Global Rules Section
| Variable | Description | Required | Data Type | Length |
|---|
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0061 | Domains referenced in data definition document (define.xml) should be included in the submission. | Find | Domain referenced in define.xml, but dataset is missing |
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| SD1020 | Demographics (DM) dataset must be included in every submission. | Find | Missing DM dataset |
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| SD1061 | Microbiology Specimen (MB) dataset should be included when a Microbiology Susceptibility Test (MS) dataset is present. | Find | Missing MB dataset when MS dataset is present |
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| SD1106 | Adverse Events (AE) dataset should be included in every submission. | Find | Missing AE dataset |
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| SD1107 | Lab Test Results (LB) dataset should be included in every submission. | Find | Missing LB dataset |
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| SD1108 | Vital Signs (VS) dataset should be included in every submission. | Find | Missing VS dataset |
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| SD1109 | Exposure (EX) dataset should be included in every submission. | Find | Missing EX dataset |
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| SD1110 | Disposition (DS) dataset should be included in every submission. | Find | Missing DS dataset |
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| SD1111 | Subject Elements (SE) dataset should be included in every submission. | Find | Missing SE dataset |
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| SD1112 | Trial Arms (TA) dataset should be included in every submission. | Find | Missing TA dataset |
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| SD1113 | Trial Elements (TE) dataset should be included in every submission. | Find | Missing TE dataset |
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| SD1115 | Trial Summary (TS) dataset must be included in every submission. | Find | Missing TS dataset |
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| SD1270 | Pharmacokinetic Concentrations (PC) dataset should be included when a Pharmacokinetic Parameters (PP) dataset is present. | Find | Missing PC dataset when PP dataset is present |
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| SD1321 | A treatment-emergent flag should be included in SUPPAE according to the FDA business rule that states, 'A treatment-emergent flag should be submitted'. | Find | No Treatment Emergent info for Adverse Event (missing SUPPAE) |
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Back to topUnrecognized
| Variable | Description | Required | Data Type | Length |
|---|
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD9999 | The structure for custom dataset should be based on one of the general observation classes (EVENTS, FINDINGS, INTERVENTIONS) defined by the SDTM model. | Property | Dataset %Domain% class not recognized |
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Trial Arms
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| ARMCD | Planned Arm Code |
|
text | 200 |
| ARM | Description of Planned Arm |
|
text | 200 |
| TAETORD | Planned Order of Element within Arm |
|
integer | 200 |
| ETCD | Element Code |
|
text | 200 |
| ELEMENT | Description of Element | text | 200 | |
| TABRANCH | Branch | text | 200 | |
| TATRANS | Transition Rule | text | 200 | |
| EPOCH | Epoch |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
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| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
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| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
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| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0011 | Description of Arm (ARM) must equal 'Screen Failure' when Arm Code (ARMCD) is 'SCRNFAIL', and vice versa. | Condition | ARM is not 'Screen Failure' when ARMCD equals 'SCRNFAIL', or vice versa |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0053 | Description of Arm (ARM) must equal 'Not Assigned' when Arm Code (ARMCD) is 'NOTASSGN', and vice versa. | Condition | ARM is not 'Not Assigned' when ARMCD equals 'NOTASSGN', or vice versa |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0067 | Element Code (ETCD) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN'). | Lookup | Invalid ETCD |
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| SD1004 | The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length. | Regex | Invalid value for ARMCD |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1009 | The value of Element Code (ETCD) should be no more than 8 characters in length. | Regex | Invalid value for ETCD |
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| SD1012 | The combination of Element Code (ETCD) and Description of Element (ELEMENT) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN'). | Lookup | Invalid ETCD/ELEMENT |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1027 | Description of Element (ELEMENT) must have a unique value for a given value of Element Code (ETCD) within the domain. | Unique | Non-unique value for ELEMENT within ETCD |
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| SD1033 | A value for Description of Planned Arm (ARM) must have a unique value for Planned Arm Code (ARMCD) with the domain. | Unique | Inconsistent value for ARM |
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| SD1034 | A value for Planned Arm Code (ARMCD) must have a unique value for Description of Planned Arm (ARM) with the domain. | Unique | Inconsistent value for ARMCD |
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| SD1050 | Element Code (ETCD) must have a unique value for a given value of Description of Element (ELEMENT) within the domain. | Unique | Non-unique value for ETCD within ELEMENT |
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| SD1052 | Order of Element within Arm (TAETORD) must have a unique value for a given value of Planned Arm Code (ARMCD) within the domain. | Unique | Non-unique value for TAETORD within ARMCD |
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| SD1053 | Records for subjects who failed a screening or were not assigned to study treatment (ARMCD is 'SCRNFAIL' or 'NOTASSGN') should not be included in the Trial Arms (TA) or Trial Visits (TV) datasets. | Condition | Unexpected value for ARMCD variable |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1267 | Planned Order of Element within Arm (TAETORD) variable value must be an integer. | Regex | Invalid value for TAETORD |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1354 | Arm Code (ARMCD) values defined in Trial Arms (TA) should be assigned to at least one subject (USUBJID) in Demographics (DM). | Lookup | ARMCD value does not present in DM |
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Trial Disease Assessments
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| TDORDER | Sequence of Planned Assessment Schedule |
|
integer | 200 |
| TDANCVAR | Anchor Variable Name |
|
text | 200 |
| TDSTOFF | Offset from the Anchor |
|
datetime | 200 |
| TDTGTPAI | Planned Assessment Interval |
|
datetime | 200 |
| TDMINPAI | Planned Assessment Interval Minimum |
|
datetime | 200 |
| TDMAXPAI | Planned Assessment Interval Maximum |
|
datetime | 200 |
| TDNUMRPT | Maximum Number of Actual Assessments |
|
integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
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| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
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| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
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| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1301 | Offset from the Anchor (TDSTOFF) variable value must be either 0, ISO 8601 format for duration (e.g., P80Y), or null. | Regex | Invalid value for TDSTOFF variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
Trial Elements
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| ETCD | Element Code |
|
text | 200 |
| ELEMENT | Description of Element |
|
text | 200 |
| TESTRL | Rule for Start of Element |
|
text | 200 |
| TEENRL | Rule for End of Element | text | 200 | |
| TEDUR | Planned Duration of Element | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
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| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0089 | At least one of Rule for End of Element (TEENRL) or Planned Duration of Element (TEDUR) should be populated. | Condition | Missing values for TEENRL and TEDUR |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1009 | The value of Element Code (ETCD) should be no more than 8 characters in length. | Regex | Invalid value for ETCD |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1064 | The value of Element Code (ETCD) variable must be unique within Trial Elements (TE) domain. | Unique | Duplicate ETCD value |
|
|
| SD1068 | The value of Element (Description of Element) variable must be unique within Trial Elements (TE) domain. | Unique | Duplicate ELEMENT value |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1271 | The combination of Description of Element (ELEMENT), Rule for Start of Element (TESTRL), Rule for End of Element (TEENRL), and Planned Duration of Element (TEDUR) should be unique for each Element Code (ETCD). | Unique | The combination of ELEMENT, TESTRL TEENRL, and TEDUR is not unique for each ETCD |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1378 | Element Code (ETCD) values defined in Trial Elements (TE) should be assigned for at least one Arm Code (ARMCD) in Trial Arms (Trial Arms). | Lookup | ETCD value does not present in TA |
|
|
| SD1379 | Element Code (ETCD) values defined in Trial Elements (TE) should be assigned to at least one subject (USUBJID) in Subject Elements (SE). | Lookup | ETCD value does not present in SE |
|
Trial Inclusion/Exclusion Criteria
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| IETESTCD | Inclusion/Exclusion Criterion Short Name |
|
text | 200 |
| IETEST | Inclusion/Exclusion Criterion |
|
text | 200 |
| IECAT | Inclusion/Exclusion Category |
|
text | 200 |
| IESCAT | Inclusion/Exclusion Subcategory | text | 200 | |
| TIRL | Inclusion/Exclusion Criterion Rule | text | 200 | |
| TIVERS | Protocol Criteria Versions | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1150 | All values of Inclusion/Exclusion Criterion (IETEST) should be the same for a given value of Inclusion/Exclusion Criterion Short Name (IETESTCD) and Protocol Criteria Versions (TIVERS). | Unique | Inconsistent value for IETEST within IETESTCD |
|
|
| SD1151 | All values of Inclusion/Exclusion Criterion Short Name (IETESTCD) should be the same for a given value of Inclusion/Exclusion Criterion (IETEST) and Protocol Criteria Versions (TIVERS). | Unique | Inconsistent value for IETESTCD within IETEST |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1286 | A value of Incl/Excl Criterion Short Name (IETESTCD) must be unique within a version of inclusion/exclusion criteria (TIVERS). | Unique | IETESTCD is not unique within TIVERS |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
Trial Summary
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| TSSEQ | Sequence Number |
|
float | 200 |
| TSGRPID | Group ID | text | 200 | |
| TSPARMCD | Trial Summary Parameter Short Name |
|
text | 200 |
| TSPARM | Trial Summary Parameter |
|
text | 200 |
| TSVAL | Parameter Value | text | 200 | |
| TSVAL1 | Parameter Value 1 | text | 200 | |
| TSVAL2 | Parameter Value 2 | text | 200 | |
| TSVAL3 | Parameter Value 3 | text | 200 | |
| TSVAL4 | Parameter Value 4 | text | 200 | |
| TSVAL5 | Parameter Value 5 | text | 200 | |
| TSVAL6 | Parameter Value 6 | text | 200 | |
| TSVAL7 | Parameter Value 7 | text | 200 | |
| TSVAL8 | Parameter Value 8 | text | 200 | |
| TSVAL9 | Parameter Value 9 | text | 200 | |
| TSVAL10 | Parameter Value 10 | text | 200 | |
| TSVALNF | Parameter Null Flavor | text | 200 | |
| TSVALCD | Parameter Value Code | text | 200 | |
| TSVCDREF | Name of the Reference Terminology | text | 200 | |
| TSVCDVER | Version of the Reference Terminology | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0019 | The value of Parameter (--PARM) variable should be no more than 40 characters in length. | Regex | Invalid value for %Domain%PARM variable |
|
|
| SD0020 | The value of Parameter Short Name (--PARMCD) variables should be no more than 8 characters in length. | Regex | Invalid value for %Domain%PARMCD variable |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1038 | Sequence Number (TSSEQ) must have a unique value for a given value of Trial Summary Parameter Short Name (TSPARMCD) within the domain. | Unique | Non-unique value for TSSEQ variable within TSPARMCD |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1069 | All values of a Parameter (--PARM) variables should be the same for a given value of a Parameter Short Name (--PARMCD) variables. | Unique | Inconsistent value for %Domain%PARM within %Domain%PARMCD |
|
|
| SD1070 | All values of a Parameter Short Name (--PARMCD) variables should be the same for a given value of a Parameter (--PARM) variables. | Unique | Inconsistent value for %Domain%PARMCD within %Domain%PARM |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1214 | Trial Summary (TS) domain must contain only one record for 'ADDON' Parameter. | Unique | Multiple ADDON records |
|
|
| SD1215 | TSVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD='AGEMAX'. | Regex | Invalid TSVAL value for AGEMAX |
|
|
| SD1216 | Trial Summary (TS) domain must contain only one record for 'AGEMAX' Parameter. | Unique | Multiple AGEMAX records |
|
|
| SD1217 | TSVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD='AGEMIN'. | Regex | Invalid TSVAL value for AGEMIN |
|
|
| SD1218 | Trial Summary (TS) domain must contain only one record for 'AGEMIN' Parameter. | Unique | Multiple AGEMIN records |
|
|
| SD1219 | TSVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD='LENGTH'. | Regex | Invalid TSVAL value for LENGTH |
|
|
| SD1220 | Trial Summary (TS) domain must contain only one record for 'LENGTH' Parameter. | Unique | Multiple LENGTH records |
|
|
| SD1221 | TSVAL for PLANSUB record must be numeric. | Condition | Invalid TSVAL value for PLANSUB |
|
|
| SD1222 | Trial Summary (TS) domain must contain only one record for 'PLANSUB' Parameter. | Unique | Multiple PLANSUB records |
|
|
| SD1223 | TSVAL for RANDOM record must be 'Y' or 'N'. | Match | Invalid TSVAL value for RANDOM |
|
|
| SD1224 | Trial Summary (TS) domain must contain only one record for 'RANDOM' Parameter. | Unique | Multiple RANDOM records |
|
|
| SD1225 | Trial Summary (TS) domain must contain only one record for 'SEXPOP' Parameter. | Unique | Multiple SEXPOP records |
|
|
| SD1227 | Trial Summary (TS) domain must contain only one record for 'NARMS' Parameter. | Unique | Multiple NARMS records |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1260 | The Version of the Reference Terminology variable (TSVCDVER) should be populated with the version number of the Reference Terminology when that Reference Terminology is versioned. | Condition | TSVCDVER is null when Reference Terminology is versioned |
|
|
| SD1268 | The Name of the Reference Terminology (TSVCDREF) must be populated when the Version of the Reference Terminology (TSVCDVER) is populated. | Condition | TSVCDREF is null when TSVCDVER is populated |
|
|
| SD1269 | For the trial summary parameter Randomization Quotient (TSPARMCD = 'RANDQT'), the value must always be a number between 0 and 1, with some cases where the ratio might be equal to 1. | Condition | TSVAL is not between 0 and 1 when TSPARMCD = 'RANDQT' |
|
|
| SD1278 | Parameter Value Code (TSVALCD) and Parameter Value (TSVAL) should have a one-to-one relationship. | Unique | Inconsistent value for TSVALCD within TSVAL |
|
|
| SD1295 | TSVAL for ADDON record must be 'Y' or 'N'. | Match | Invalid TSVAL value for ADDON parameter |
|
|
| SD1296 | TSVAL for ADAPT record must be 'Y' or 'N'. | Match | Invalid TSVAL value for ADAPT parameter |
|
|
| SD1297 | TSVAL should not be populated with a value from the ISO 21090 null flavor codelist, or synonyms of the values. The TSVALNF variable should be used to capture these values, not TSVAL. | Condition | TSVAL is populated with a value from the ISO 21090 null flavor codelist |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1306 | When the study population is healthy subjects (TSPARMCD = 'HLTSUBJI' and TSVAL = 'Y'), the Diagnosis Group parameter should be provided with a null Parameter Value (TSVAL should be null when TSPARMCD = 'TDIGRP'). | Find | The TDIGRP Trial Summary Parameter is not provided with TSVAL equal to null when HLTSUBJI parameter equals 'Y' |
|
|
| SD1307 | When the study population is not healthy subjects (TSPARMCD = 'HLTSUBJI' and TSVAL = 'N'), the Diagnosis Group parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'TDIGRP'). | Find | TSVAL is missing for the TDIGRP Trial Summary Parameter when HLTSUBJI parameter equals 'N' |
|
|
| SD1308 | When test product is added to existing treatment (TSPARMCD = 'ADDON' and TSVAL = 'Y'), the Current Therapy or Treatment parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'CURTRT'). | Find | TSVAL is missing for the CURTRT Trial Summary Parameter when ADDON parameter equals 'Y' |
|
|
| SD1309 | When the study type is interventional (TSPARMCD = 'STYPE' and TSVAL = 'INTERVENTIONAL'), the Investigational Therapy or Treatment parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'TRT'). | Find | TSVAL is missing for the TRT Trial Summary Parameter when STYPE parameter equals 'INTERVENTIONAL' |
|
|
| SD1310 | When the study type is interventional (TSPARMCD = 'STYPE' and TSVAL = 'INTERVENTIONAL'), the Intervention Model parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'INTMODEL'). | Find | TSVAL is missing for the INTMODEL Trial Summary Parameter when STYPE parameter equals 'INTERVENTIONAL' |
|
|
| SD1311 | When the study type is interventional (TSPARMCD = 'STYPE' and TSVAL = 'INTERVENTIONAL'), the Intervention Type parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'INTTYPE'). | Find | TSVAL is missing for the INTTYPE Trial Summary Parameter when STYPE parameter equals 'INTERVENTIONAL' |
|
|
| SD1312 | When the study type is interventional (TSPARMCD = 'STYPE' and TSVAL = 'INTERVENTIONAL'), the Pharmacologic Class parameter should be provided with Parameter Value populated (TSVAL should not be null when TSPARMCD = 'PCLAS'). | Find | TSVAL is missing for the PCLAS Trial Summary Parameter when STYPE parameter equals 'INTERVENTIONAL' |
|
|
| SD1323 | TSVAL for FCNTRY record must be a valid term from Geopolitical Entities, Names, and Codes (GENC) dictionary. GENC is an FDA requirement. Not that the Country code values in GENC dictionary and ISO 3166 forrmat are the same fro most cases. | Match | Invalid TSVAL value for FCNTRY |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD2017 | Value for Parameter Value (--VAL) variable must be populated. --VAL can only be null when Parameter Null Flavor (--VALNF) variable value is populated. | Condition | Missing values for both %Domain%VAL and %Domain%VALNF |
|
|
| SD2018 | Value for Parameter Null Flavor (--VALNF) variable should be NULL when Parameter Value (--VAL) variable value can be populated. | Condition | Both %Domain%VAL and %Domain%VALNF variables are populated |
|
|
| SD2201 | 'Added on to Existing Treatments' (ADDON) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing ADDON Trial Summary Parameter |
|
|
| SD2202 | 'Planned Maximum Age of Subjects' (AGEMAX) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing AGEMAX Trial Summary Parameter |
|
|
| SD2203 | 'Planned Minimum Age of Subject' (AGEMIN) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing AGEMIN Trial Summary Parameter |
|
|
| SD2204 | 'Trial Length' (LENGTH) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing LENGTH Trial Summary Parameter |
|
|
| SD2205 | 'Planned Number of Subjects' (PLANSUB) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing PLANSUB Trial Summary Parameter |
|
|
| SD2206 | 'Trial is Randomized' (RANDOM) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing RANDOM Trial Summary Parameter |
|
|
| SD2207 | 'Sex of Participants' (SEXPOP) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing SEXPOP Trial Summary Parameter |
|
|
| SD2208 | 'Study Stop Rules' (STOPRULE) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing STOPRULE Trial Summary Parameter |
|
|
| SD2209 | 'Trial Blinding Schema' (TBLIND) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TBLIND Trial Summary Parameter |
|
|
| SD2210 | 'Control Type' (TCNTRL) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TCNTRL Trial Summary Parameter |
|
|
| SD2211 | 'Diagnosis Group' (TDIGRP) record must be populated in Trial Summary (TS) domain when study population is unhealthy subjects (HLTSUBJI = 'N'). It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TDIGRP Trial Summary Parameter |
|
|
| SD2212 | 'Trial Indication Type' (TINDTP) record must be populated in Trial Summary (TS) domain when study type is 'INTERVENTIONAL'. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TINDTP Trial Summary Parameter |
|
|
| SD2213 | 'Trial Title' (TITLE) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TITLE Trial Summary Parameter |
|
|
| SD2214 | 'Trial Phase Classification' (TPHASE) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TPHASE Trial Summary Parameter |
|
|
| SD2215 | 'Trial Type (TTYPE) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TTYPE Trial Summary Parameter |
|
|
| SD2216 | 'Current Therapy or Treatment' (CURTRT) record must be populated in Trial Summary (TS) domain when ADDON is 'Y'. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing CURTRT Trial Summary Parameter |
|
|
| SD2217 | 'Trial Primary Objective' (OBJPRIM) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing OBJPRIM Trial Summary Parameter |
|
|
| SD2218 | 'Clinical Study Sponsor' (SPONSOR) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing SPONSOR Trial Summary Parameter |
|
|
| SD2219 | 'Investigational Therapy or Treatment' (TRT) record must be populated in Trial Summary (TS) domain when study type is 'INTERVENTIONAL'. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing TRT Trial Summary Parameter |
|
|
| SD2221 | 'Registry Identifier' (REGID) record may be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and all more recent SDTM versions. | Find | Missing REGID Trial Summary Parameter |
|
|
| SD2222 | 'Primary Outcome Measure' (OUTMSPRI) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing OUTMSPRI Trial Summary Parameter |
|
|
| SD2223 | 'Pharmacological Class of Investigational Therapy' (PCLAS) record must be populated in Trial Summary (TS) domain when study type is 'INTERVENTIONAL' and if Intervention Type (INTTYPE) is one for which pharmacological class is applicable. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing PCLAS Trial Summary Parameter |
|
|
| SD2224 | 'Planned Country of Investigational Sites' (FCNTRY) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing FCNTRY Trial Summary Parameter |
|
|
| SD2225 | 'Adaptive Design' (ADAPT) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing ADAPT Trial Summary Parameter |
|
|
| SD2226 | 'Data Cutoff Date' (DCUTDTC) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing DCUTDTC Trial Summary Parameter |
|
|
| SD2227 | 'Data Cutoff Description' (DCUTDESC) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing DCUTDESC Trial Summary Parameter |
|
|
| SD2228 | 'Intervention Model' (INTMODEL) record must be populated in Trial Summary (TS) domain when study type is 'INTERVENTIONAL'. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing INTMODEL Trial Summary Parameter |
|
|
| SD2229 | 'Planned Number of Arms' (NARMS) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing NARMS Trial Summary Parameter |
|
|
| SD2230 | 'Study Type' (STYPE) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing STYPE Trial Summary Parameter |
|
|
| SD2231 | 'Intervention Type' (INTTYPE) record must be populated in Trial Summary (TS) domain when study type is 'INTERVENTIONAL'. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing INTTYPE Trial Summary Parameter |
|
|
| SD2232 | 'Study Start Date' (SSTDTC) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing SSTDTC Trial Summary Parameter |
|
|
| SD2233 | 'Study End Date' (SENDTC) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing SENDTC Trial Summary Parameter |
|
|
| SD2234 | 'Actual Number of Subjects' (ACTSUB) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing ACTSUB Trial Summary Parameter |
|
|
| SD2235 | 'Healthy Subject Indicator' (HLTSUBJI) record must be populated in Trial Summary (TS) domain. It is expected for SDTM IG v3.1.2 data and required for data in all more recent SDTM versions. | Find | Missing HLTSUBJI Trial Summary Parameter |
|
|
| SD2240 | TSVCDREF variable value must be 'SNOMED' when TSPARAMCD='INDIC'. | Condition | Invalid TSVCDREF value for INDIC |
|
|
| SD2241 | TSVCDREF variable value must be 'UNII' when TSPARMCD='CURTRT'. | Condition | Invalid TSVCDREF value for CURTRT |
|
|
| SD2242 | TSVCDREF variable value must be 'UNII' when TSPARMCD='TRT'. | Condition | Invalid TSVCDREF value for TRT |
|
|
| SD2243 | TSVCDREF variable value must be either 'MED-RT' or 'NDF-RT' when TSPARMCD='PCLAS'. (Note: Any version 2018-02-05 or earlier is NDF-RT, and any version after is MED-RT). | Condition | Invalid TSVCDREF value for PCLAS |
|
|
| SD2244 | TSVCDREF variable value must be 'GENC' (for FDA submissions) or 'ISO 3166' when TSPARMCD='FCNTRY'. | Condition | Invalid TSVCDREF value for FCNTRY |
|
|
| SD2245 | TSVAL variable value must be in ISO 8601 format when TSPARMCD='DCUTDTC'. | Condition | Invalid TSVAL value for DCUTDTC |
|
|
| SD2246 | TSVAL variable value must be numeric when TSPARMCD='NARMS'. | Condition | Invalid TSVAL value for NARMS |
|
|
| SD2247 | TSVAL variable value must be in ISO 8601 format when TSPARMCD='SSTDTC'. | Condition | Invalid TSVAL value for SSTDTC |
|
|
| SD2247A | TSVAL variable value must be in ISO 8601 format and include at least full date, when TSPARMCD='SSTDTC'. | Condition | Incomplete date for study start date |
|
|
| SD2248 | TSVAL variable value must be in ISO 8601 format when TSPARMCD='SENDTC'. | Condition | Invalid TSVAL value for SENDTC |
|
|
| SD2249 | TSVAL variable value must be numeric when TSPARMCD='ACTSUB'. | Condition | Invalid TSVAL value for ACTSUB |
|
|
| SD2250 | TSVAL for CURTRT record must be a valid preferred term from FDA Substance Registration System (SRS). | Lookup | Invalid TSVAL value for CURTRT |
|
|
| SD2251 | TSVALCD for CURTRT record must be a valid unique ingredient identifier from FDA Substance Registration System (SRS). | Lookup | Invalid TSVALCD value for CURTRT |
|
|
| SD2252 | TSVAL and TSVALCD values must be populated from the same name record in FDA Substance Registration System (SRS). | Lookup | TSVAL/TSVALCD value mismatch for CURTRT |
|
|
| SD2253 | TSVAL for COMPTRT record must be a valid preferred term from FDA Substance Registration System (SRS). | Lookup | Invalid TSVAL value for COMPTRT |
|
|
| SD2254 | TSVALCD for COMPTRT record must be a valid unique ingredient identifier from FDA Substance Registration System (SRS). | Lookup | Invalid TSVALCD value for COMPTRT |
|
|
| SD2255 | TSVAL and TSVALCD values must be populated from the same name record in FDA Substance Registration System (SRS). | Lookup | TSVAL/TSVALCD value mismatch for COMPTRT |
|
|
| SD2256 | TSVCDREF variable value must be 'UNII' when TSPARMCD='COMPTRT'. | Condition | Invalid TSVCDREF value for COMPTRT |
|
|
| SD2257 | TSVAL for INDIC record must be a valid term from SNOMED CT. | Lookup | Invalid TSVAL value for INDIC |
|
|
| SD2258 | TSVALCD for INDIC record must be a valid concept ID from SNOMED CT. | Lookup | Invalid TSVALCD value for INDIC |
|
|
| SD2259 | TSVAL and TSVALCD values must be populated from the same concept description record in SNOMED CT. | Lookup | TSVAL/TSVALCD value mismatch for INDIC |
|
|
| SD2260 | TSVAL for TRT record must be a valid preferred term from FDA Substance Registration System (SRS). | Lookup | Invalid TSVAL value for TRT |
|
|
| SD2261 | TSVALCD for TRT record must be a valid unique ingredient identifier from FDA Substance Registration System (SRS). | Lookup | Invalid TSVALCD value for TRT |
|
|
| SD2262 | TSVAL and TSVALCD values must be populated from the same name record in FDA Substance Registration System (SRS). | Lookup | TSVAL/TSVALCD value mismatch for TRT |
|
|
| SD2263 | TSVAL for PCLAS record must be a valid term from MED-RT or NDF-RT (Note: Any version 2018-02-05 or earlier uses NDF-RT, and any version after is MED-RT). | Lookup | Invalid TSVAL value for PCLAS |
|
|
| SD2264 | TSVALCD for PCLAS record must be a valid code from MED-RT or NDF-RT (Note: Any version 2018-02-05 or earlier uses NDF-RT, and any version after is MED-RT). | Lookup | Invalid TSVALCD value for PCLAS |
|
|
| SD2265 | TSVAL and TSVALCD values must be populated from the same record in MED-RT or NDF-RT (Note: Any version 2018-02-05 or earlier uses NDF-RT, and any version after is MED-RT). | Lookup | TSVAL/TSVALCD value mismatch for PCLAS |
|
|
| SD2266 | TSVCDREF variable value must be 'SNOMED' when TSPARAMCD='TDIGRP'. | Condition | Invalid TSVCDREF value for TDIGRP |
|
|
| SD2267 | TSVAL for TDIGRP record must be a valid term from SNOMED CT. | Lookup | Invalid TSVAL value for TDIGRP |
|
|
| SD2268 | TSVALCD for TDIGRP record must be a valid concept ID from SNOMED CT. | Lookup | Invalid TSVALCD value for TDIGRP |
|
|
| SD2269 | TSVAL and TSVALCD values must be populated from the same concept description record in SNOMED CT. | Lookup | TSVAL/TSVALCD value mismatch for TDIGRP |
|
|
| SD2273 | 'Extension Trial Indicator' (EXTTIND) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing EXTTIND Trial Summary Parameter |
|
|
| SD2274 | 'Number of Groups/Cohorts' (NCOHORT) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing NCOHORT Trial Summary Parameter |
|
|
| SD2275 | 'Trial Secondary Objective' (OBJSEC) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing OBJSEC Trial Summary Parameter |
|
|
| SD2276 | 'Pediatric Postmarket Study Indicator' (PDPSTIND) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing PDPSTIND Trial Summary Parameter |
|
|
| SD2277 | 'Pediatric Study Indicator' (PDSTIND) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing PDSTIND Trial Summary Parameter |
|
|
| SD2278 | 'Pediatric Investigation Plan Indicator' (PIPIND) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing PIPIND Trial Summary Parameter |
|
|
| SD2279 | 'Rare Disease Indicator' (RDIND) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing RDIND Trial Summary Parameter |
|
|
| SD2280 | 'SDTM IG Version' (SDTIGVER) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing SDTIGVER Trial Summary Parameter |
|
|
| SD2281 | 'SDTM Version' (SDTMVER) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing SDTMVER Trial Summary Parameter |
|
|
| SD2282 | 'Therapeutic Area' (THERAREA) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG). | Find | Missing THERAREA Trial Summary Parameter |
|
|
| SD2283 | Value for the Null Flavor (TSVALNF) variable must be populated using terms found in ISO 21090. | Match | Value for TSVALNF not found in ISO 21090 |
|
Trial Visits
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| VISITNUM | Visit Number |
|
float | 200 |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| ARMCD | Planned Arm Code | text | 200 | |
| ARM | Description of Planned Arm | text | 200 | |
| TVSTRL | Visit Start Rule |
|
text | 200 |
| TVENRL | Visit End Rule | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD1004 | The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length. | Regex | Invalid value for ARMCD |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1033 | A value for Description of Planned Arm (ARM) must have a unique value for Planned Arm Code (ARMCD) with the domain. | Unique | Inconsistent value for ARM |
|
|
| SD1034 | A value for Planned Arm Code (ARMCD) must have a unique value for Description of Planned Arm (ARM) with the domain. | Unique | Inconsistent value for ARMCD |
|
|
| SD1053 | Records for subjects who failed a screening or were not assigned to study treatment (ARMCD is 'SCRNFAIL' or 'NOTASSGN') should not be included in the Trial Arms (TA) or Trial Visits (TV) datasets. | Condition | Unexpected value for ARMCD variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
Associated Persons Demographics
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| APID | Associated Persons Identifier |
|
text | 200 |
| RSUBJID | Related Subject | text | 200 | |
| RDEVID | Related Device | text | 200 | |
| SREL | Subject, Device or Study Relationship |
|
text | 200 |
| DTHDTC | Date/Time of Death | datetime | 200 | |
| DTHFL | Associated Persons Death Flag | text | 200 | |
| INVNAM | Investigator Name | text | 200 | |
| BRTHDTC | Date/Time of Birth | datetime | 200 | |
| AGE | Age | integer | 200 | |
| AGEU | Age Units | text | 200 | |
| SEX | Sex | text | 200 | |
| RACE | Race | text | 200 | |
| ETHNIC | Ethnicity | text | 200 | |
| COUNTRY | Country | text | 200 | |
| DMDTC | Date/Time of Collection | datetime | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1326 | Related Device Identifier (RDEVID) and Related Subject or Pool Identifier (RSUBJID) should not both be populated for the same record. | Condition | RDEVID is not null when RSUBJID is populated |
|
|
| SD1349 | Study Identifier (STUDYID) values should be consistent for all subjects in the Demographics (DM) domain for one study. | Unique | Inconsistent STUDYID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
Comments
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| RDOMAIN | Related Domain Abbreviation | text | 200 | |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| COSEQ | Sequence Number |
|
float | 200 |
| COGRPID | Group ID | text | 200 | |
| COREFID | Reference ID | text | 200 | |
| COSPID | Sponsor-Defined Identifier | text | 200 | |
| COLNKID | Link ID | text | 200 | |
| COLNKGRP | Link Group ID | text | 200 | |
| IDVAR | Identifying Variable | text | 200 | |
| IDVARVAL | Identifying Variable Value | text | 200 | |
| COREF | Comment Reference | text | 200 | |
| COVAL | Comment |
|
text | 200 |
| COVAL1 | Comment 1 | text | 200 | |
| COVAL2 | Comment 2 | text | 200 | |
| COVAL3 | Comment 3 | text | 200 | |
| COVAL4 | Comment 4 | text | 200 | |
| COVAL5 | Comment 5 | text | 200 | |
| COVAL6 | Comment 6 | text | 200 | |
| COVAL7 | Comment 7 | text | 200 | |
| COVAL8 | Comment 8 | text | 200 | |
| COVAL9 | Comment 9 | text | 200 | |
| COVAL10 | Comment 10 | text | 200 | |
| COEVAL | Evaluator | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| CODTC | Date/Time of Comment | datetime | 200 | |
| CODY | Study Day of Visit/Collection/Exam | integer | 200 | |
| COTPT | Planned Time Point Name | text | 200 | |
| COTPTNUM | Planned Time Point Number | float | 200 | |
| COELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| COTPTREF | Time Point Reference | text | 200 | |
| CORFTDTC | Date/Time of Reference Time Point | datetime | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD0072 | Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data. | Metadata | Invalid RDOMAIN |
|
|
| SD0075 | Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain. | Metadata | Invalid IDVAR |
|
|
| SD0077 | Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain. | Lookup | Invalid referenced record |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1008 | The value of Date/Time of Comment (CODTC) should be NULL when comments are related to a specific parent record or group of parent records in a domain (RDOMAIN, IDVAR and IDVARVAL are populated). | Condition | CODTC is populated when comment is a child record of another domain |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1065 | Value of Related Domain Abbreviation (RDOMAIN) variable must be populated when value of Identifying Variable (IDVAR) variable is populated. | Condition | Missing RDOMAIN value when IDVAR is populated |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1119 | In the Comments (CO) domain, the following Identifier and Timing variables are Permissible and may be populated as appropriate when comments are not related to other domain records (i.e., RDOMAIN and IDVAR variable values are not populated): COGRPID, COREFID, COSPID, VISIT, VISITNUM, VISITDY, TAETORD, CODY, COTPT, COTPTNUM, COELTM, COTPTREF, CORFTDTC. | Condition | Inappropriate usage of variables in CO domain when comment is a child record of another domain |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
Device Identifiers
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| DISEQ | Sequence Number | float | 200 | |
| DIPARMCD | Device Identifier Element Short Name |
|
text | 200 |
| DIPARM | Device Identifier Element Name |
|
text | 200 |
| DIVAL | Device Identifier Element Value |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0019 | The value of Parameter (--PARM) variable should be no more than 40 characters in length. | Regex | Invalid value for %Domain%PARM variable |
|
|
| SD0020 | The value of Parameter Short Name (--PARMCD) variables should be no more than 8 characters in length. | Regex | Invalid value for %Domain%PARMCD variable |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1069 | All values of a Parameter (--PARM) variables should be the same for a given value of a Parameter Short Name (--PARMCD) variables. | Unique | Inconsistent value for %Domain%PARM within %Domain%PARMCD |
|
|
| SD1070 | All values of a Parameter Short Name (--PARMCD) variables should be the same for a given value of a Parameter (--PARM) variables. | Unique | Inconsistent value for %Domain%PARMCD within %Domain%PARM |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1234 | Device Type (DEVTYPE) Parameter must be populated for each Medical Device in the Device Identifiers (DI) domain. | Find | Missing DEVTYPE Parameter for Device |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1453 | The value of Sequence Number (DISEQ) variable must be unique for each record within a domain and within each Sponsor Device Identifier (SPDEVID) | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
Demographics
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| SUBJID | Subject Identifier for the Study |
|
text | 200 |
| RFSTDTC | Subject Reference Start Date/Time | datetime | 200 | |
| RFENDTC | Subject Reference End Date/Time | datetime | 200 | |
| RFXSTDTC | Date/Time of First Study Treatment | datetime | 200 | |
| RFXENDTC | Date/Time of Last Study Treatment | datetime | 200 | |
| RFICDTC | Date/Time of Informed Consent | datetime | 200 | |
| RFPENDTC | Date/Time of End of Participation | datetime | 200 | |
| DTHDTC | Date/Time of Death | datetime | 200 | |
| DTHFL | Subject Death Flag | text | 200 | |
| SITEID | Study Site Identifier |
|
text | 200 |
| INVID | Investigator Identifier | text | 200 | |
| INVNAM | Investigator Name | text | 200 | |
| BRTHDTC | Date/Time of Birth | datetime | 200 | |
| AGE | Age | integer | 200 | |
| AGETXT | Age Range | text | 200 | |
| AGEU | Age Units | text | 200 | |
| SEX | Sex |
|
text | 200 |
| RACE | Race | text | 200 | |
| ETHNIC | Ethnicity | text | 200 | |
| SPECIES | Species | text | 200 | |
| STRAIN | Strain/Substrain | text | 200 | |
| SBSTRAIN | Strain/Substrain Details | text | 200 | |
| ARMCD | Planned Arm Code |
|
text | 200 |
| ARM | Description of Planned Arm |
|
text | 200 |
| ACTARMCD | Actual Arm Code |
|
text | 200 |
| ACTARM | Description of Actual Arm |
|
text | 200 |
| COUNTRY | Country |
|
text | 200 |
| DMXFN | External File Path | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DMDTC | Date/Time of Collection | datetime | 200 | |
| DMSTDTC | Start Date/Time of Observation | datetime | 200 | |
| DMENDTC | End Date/Time of Observation | datetime | 200 | |
| DMDY | Study Day of Collection | integer | 200 | |
| DMSTDY | Study Day of Start of Observation | integer | 200 | |
| DMENDY | Study Day of End of Observation | integer | 200 | |
| DMDUR | Duration | text | 200 | |
| DMTPT | Planned Time Point Name | text | 200 | |
| DMTPTNUM | Planned Time Point Number | float | 200 | |
| DMELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DMTPTREF | Time Point Reference | text | 200 | |
| DMRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DMSTRF | Start Relative to Reference Period | text | 200 | |
| DMENRF | End Relative to Reference Period | text | 200 | |
| DMEVLINT | Evaluation Interval | datetime | 200 | |
| DMEVINTX | Evaluation Interval Text | text | 200 | |
| DMSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DMSTTPT | Start Reference Time Point | text | 200 | |
| DMENRTPT | End Relative to Reference Time Point | text | 200 | |
| DMENTPT | End Reference Time Point | text | 200 | |
| DMSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DMENINT | Planned End of Assessment Interval | datetime | 200 | |
| DMDETECT | Time in Days to Detection | float | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0006 | All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, MB, MS, PC and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN') or were not treated (ACTARMCD = 'NOTTRT'). | Lookup | No baseline flag record in %Domain.From% for subject |
|
|
| SD0011 | Description of Arm (ARM) must equal 'Screen Failure' when Arm Code (ARMCD) is 'SCRNFAIL', and vice versa. | Condition | ARM is not 'Screen Failure' when ARMCD equals 'SCRNFAIL', or vice versa |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0053 | Description of Arm (ARM) must equal 'Not Assigned' when Arm Code (ARMCD) is 'NOTASSGN', and vice versa. | Condition | ARM is not 'Not Assigned' when ARMCD equals 'NOTASSGN', or vice versa |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD0066 | Planned Arm Code (ARMCD) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN'). | Lookup | Invalid ARMCD |
|
|
| SD0069 | All Demographics (DM) subjects (USUBJID) should have at least one record in the Disposition (DS) domain. The only possible exceptions for SDTMIG v3.2 (and earlier) are Screen Failures (ARMCD=SCRNFAIL) and Not Assigned Treatment (ARMCD=NOTASSGN) subjects, or subjects with ARMCD=null. There are no exceptions for SEND. | Lookup | No Disposition record found for subject |
|
|
| SD0070 | All Demographics (DM) subjects (USUBJID) participating in a study that includes investigational product should have at least one record in the Exposure (EX) domain, except for subjects who failed screening (ARMCD = 'SCRNFAIL'), were not fully assigned to an Arm (ARMCD = 'NOTASSGN') or did not receive study treatment (ACTARMCD = 'NOTTRT'). | Lookup | No Exposure record found for subject |
|
|
| SD0071 | The combination of Description of Planned Arm (ARM) and Planned Arm Code (ARMCD) values must match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN'). | Lookup | Invalid ARM/ARMCD |
|
|
| SD0083 | The value of Unique Subject Identifier (USUBJID) variable must be unique for each subject across all trials in the submission. In the Demographics (DM) domain, there should only be one record per subject. | Unique | Duplicate USUBJID in DM within STUDYID |
|
|
| SD0084 | The value of Age (AGE) cannot be less than or equal to 0. | Condition | Negative or zero value for AGE |
|
|
| SD0087 | Subject Reference Start Date/Time (RFSTDTC) should be populated for all randomized subjects, those where Planned Arm Code (ARMCD) is not equal to 'SCRNFAIL' or 'NOTASSGN' or null. | Required | RFSTDTC is not provided for a randomized subject |
|
|
| SD0088 | Subject Reference End Date/Time (RFENDTC) should be populated for all randomized subjects, those where Planned Arm Code (ARMCD) is not equal to 'SCRNFAIL' or 'NOTASSGN' or null. | Required | RFENDTC is not provided for a randomized subject |
|
|
| SD1001 | The value of Subject Identifier for the Study (SUBJID) variable must be unique for each subject within the study. | Unique | Duplicate SUBJID |
|
|
| SD1002 | Subject Reference Start Date/Time (RFSTDTC) must be less than or equal to Subject Reference End Date/Time (RFENDTC). | Condition | RFSTDTC is after RFENDTC |
|
|
| SD1004 | The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length. | Regex | Invalid value for ARMCD |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1032 | All subjects with Planned Arm Code (ARMCD) equals 'SCRNFAIL' should have records in the Inclusion/Exclusion Criteria Not Met (IE) domain. | Lookup | No records for 'SCRNFAIL' subject are found in IE domain |
|
|
| SD1033 | A value for Description of Planned Arm (ARM) must have a unique value for Planned Arm Code (ARMCD) with the domain. | Unique | Inconsistent value for ARM |
|
|
| SD1034 | A value for Planned Arm Code (ARMCD) must have a unique value for Description of Planned Arm (ARM) with the domain. | Unique | Inconsistent value for ARMCD |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1121 | Value for Age (AGE) or Age Range (AGETXT) variables should be populated for all subjects. The only exception for SDTM is for Screen Failures (ARMCD=SCRNFAIL) and Not Assigned (ARMCD=NOTASSGN) subjects, or subjects with ARMCD=null. There are no exceptions for SEND. | Condition | Neither AGE nor AGETXT values are populated |
|
|
| SD1129 | At least one of Age (AGE) or Age Text (AGETXT) variables should be included into Demographics (DM) domain. | Find | Neither AGE nor AGETXT variables are present |
|
|
| SD1133 | A value for Description of Actual Arm (ACTARM) must have a unique value for Actual Arm Code (ACTARMCD) with the domain. | Unique | Inconsistent value for ACTARM |
|
|
| SD1134 | A value for Actual Arm Code (ACTARMCD) must have a unique value for Description of Actual Arm (ACTARM) with the domain. | Unique | Inconsistent value for ACTARMCD |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1208 | Date/Time of First Study Treatment (RFXSTDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC). | Condition | RFXSTDTC date is after RFXENDTC |
|
|
| SD1209 | Value for Date/Time of Last Study Treatment (RFXENDTC) variable must be populated when Date/Time of First Study Treatment (RFXSTDTC) variable value is provided. | Condition | Missing value for RFXENDTC when RFXSTDTC is provided |
|
|
| SD1210 | Date/Time of Informed Consent (RFICDTC) variable value should be populated. It would be NULL only in studies not collecting this info. | Required | Missing value for RFICDTC |
|
|
| SD1213 | Subject Reference Start Date/Time (RFSTDTC) should be populated for all treated subjects, those where Actual Arm Code (ACTARMCD) is not equal to 'SCRNFAIL', 'NOTASSGN', 'NOTTRT', or null. | Required | RFSTDTC is not provided for a treated subject |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1240 | All subjects should have an Informed Consent record in the Disposition domain. | Lookup | No Informed Consent Obtained record in DS domain for subject |
|
|
| SD1258 | RFSTDTC must be null when actual arm indicates that the subject is a screen failure ('Screen Failure'), was not assigned to an arm ('Not Assigned'), was not treated ('NOTTRT'), or actual arm is null. This rule applies to studies where RFSTDTC is associated with a treatment date. | Condition | RFSTDTC is populated for subject who did not receive treatment |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1322 | Value for the Country (COUNTRY) variable must be populated using terms found in Geopolitical Entities, Names, and Codes (GENC) dictionary. Note that country codes in GENC and ISO 3166 are the same for most cases. | Match | Value for COUNTRY not found in GENC |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1334 | Date/Time of Informed Consent (RFICDTC) should not be after Subject Reference Start Date/Time (RFSTDTC). | Condition | RFICDTC is after RFSTDTC |
|
|
| SD1335 | Date/Time of Informed Consent (RFICDTC) should not be after Date/Time of First Study Treatment (RFXSTDTC). | Condition | RFICDTC is after RFXSTDTC |
|
|
| SD1342 | Date/Time of First Study Treatment (RFXSTDTC) variable must be populated when Date/Time of Last Study Treatment (RFXENDTC)variable value is provided. | Condition | Missing value for RFXSTDTC when RFXENDTC is provided |
|
|
| SD1343 | Date/Time of First Study Treatment (RFXSTDTC) variable must be populated when subject is treated (ACTARMCD is not 'SCRNFAIL', 'NOTTRT', 'NOTASSGN', or null). | Condition | Missing value for RFXSTDTC when subject is treated |
|
|
| SD1349 | Study Identifier (STUDYID) values should be consistent for all subjects in the Demographics (DM) domain for one study. | Unique | Inconsistent STUDYID |
|
|
| SD1375 | RFENDTC must be null when actual arm indicates that the subject is a screen failure ('Screen Failure'), was not assigned to an arm ('Not Assigned') or was not treated ('NOTTRT') (or null). This rule applies to studies where RFENDTC is associated with a treatment date. | Condition | RFENDTC is populated for subject who did not receive treatment |
|
|
| SD1376 | Subject Reference End Date/Time (RFENDTC) should be populated for all treated subjects, those where Actual Arm Code (ACTARMCD) is not equal to 'SCRNFAIL', 'NOTASSGN' or 'NOTTRT' (or null). | Required | RFENDTC is not provided for a treated subject |
|
|
| SD2001 | The value of Actual Arm Code (ACTARMCD) should be no more than 20 characters in length. | Regex | Invalid value for ACTARMCD |
|
|
| SD2002 | Actual Arm Code (ACTARMCD) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening ('SCRNFAIL'), or were not fully assigned to an Arm ('NOTASSGN'), or randomized, but not treated ('NOTTRT'), or received non-planned treatment ('UNPLAN'). | Lookup | Invalid value for ACTARMCD |
|
|
| SD2003 | Description of Actual Arm (ACTARM) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening ('Screen Failure'), or were not fully assigned to an Arm ('Not Assigned'), or randomized, but not treated ('Not Treated') or received non-planned treatment ('Unplanned Treatment'). | Lookup | Invalid value for ACTARM |
|
|
| SD2004 | Subject Death Flag (DTHFL) value must equal 'Y' when Date/Time of Death (DTHDTC) is provided. | Condition | Missing value for DTHFL when DTHDTC is populated |
|
|
| SD2005 | Date/Time of Death (DTHDTC) should be provided when subject died (DTHFL=Y). | Condition | Missing value for DTHDTC when DTHFL is populated |
|
|
| SD2019 | Age Range (AGETXT) variable values should be populated with 'number-number' format. | Regex | Invalid value for AGETXT |
|
|
| SD2020 | Age (AGE) and Age Range (AGETXT) variables should never both be populated for the same subject. | Condition | Both AGE and AGETXT variables values are populated |
|
|
| SD2021 | Either of Age (AGE) or Age Range (AGETXT) variable values should be provided when Age Units (AGEU) are populated. | Condition | Missing values for both AGE and AGETXT when AGEU is provided |
|
|
| SD2022 | Age Units (AGEU) variable values should be provided when Age (AGE) or Age Range (AGETXT) variables values are populated. | Required | Missing value for AGEU when AGE or AGETXT is populated |
|
|
| SD2023 | Age (AGE) variable values should be provided when Date/Time of Birth (BRTHDTC) variable values are populated. | Required | AGE is not provided |
|
|
| SD2236 | A value for an Actual Arm Code (ACTARMCD) variable is expected to be equal to a value of an Arm Code (ARMCD) variable. | Condition | ACTARMCD does not equal ARMCD |
|
|
| SD2237 | A value for an Actual Arm (ACTARM) variable is expected to be equal to a value of an Arm (ARM) variable. | Condition | ACTARM does not equal ARM |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
Device-Subject Relationships
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
Subject Elements
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| SESEQ | Sequence Number |
|
float | 200 |
| SEGRPID | Group ID | text | 200 | |
| SEREFID | Reference ID | text | 200 | |
| SESPID | Sponsor-Defined Identifier | text | 200 | |
| ETCD | Element Code |
|
text | 200 |
| ELEMENT | Description of Element | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SEDTC | Date/Time of Collection | datetime | 200 | |
| SESTDTC | Start Date/Time of Element |
|
datetime | 200 |
| SEENDTC | End Date/Time of Element | datetime | 200 | |
| SEDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| SESTDY | Study Day of Start of Observation | integer | 200 | |
| SEENDY | Study Day of End of Observation | integer | 200 | |
| SEDUR | Duration | text | 200 | |
| SETPT | Planned Time Point Name | text | 200 | |
| SETPTNUM | Planned Time Point Number | float | 200 | |
| SEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SETPTREF | Time Point Reference | text | 200 | |
| SERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SESTRF | Start Relative to Reference Period | text | 200 | |
| SEENRF | End Relative to Reference Period | text | 200 | |
| SEEVLINT | Evaluation Interval | text | 200 | |
| SEEVINTX | Evaluation Interval Text | text | 200 | |
| SESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SESTTPT | Start Reference Time Point | text | 200 | |
| SEENRTPT | End Relative to Reference Time Point | text | 200 | |
| SEENTPT | End Reference Time Point | text | 200 | |
| SEUPDES | Description of Unplanned Element | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD0067 | Element Code (ETCD) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN'). | Lookup | Invalid ETCD |
|
|
| SD0092 | Description of Unplanned Element (SEUPDES) should be populated when subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN'. | Condition | Missing value for SEUPDES when ETCD='UNPLAN' |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1009 | The value of Element Code (ETCD) should be no more than 8 characters in length. | Regex | Invalid value for ETCD |
|
|
| SD1010 | Description of Element (ELEMENT) should be NULL when subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN'. | Condition | ELEMENT value is populated when ETCD= 'UNPLAN' |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1012 | The combination of Element Code (ETCD) and Description of Element (ELEMENT) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN'). | Lookup | Invalid ETCD/ELEMENT |
|
|
| SD1013 | Planned Order of Elements within Arm (TAETORD) should be NULL when subject's experience for a particular period of time is represented as an unplanned Element (ETCD = 'UNPLAN'). | Condition | TAETORD is populated, ETCD = 'UNPLAN' |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1027 | Description of Element (ELEMENT) must have a unique value for a given value of Element Code (ETCD) within the domain. | Unique | Non-unique value for ELEMENT within ETCD |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1050 | Element Code (ETCD) must have a unique value for a given value of Description of Element (ELEMENT) within the domain. | Unique | Non-unique value for ETCD within ELEMENT |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1266 | When the Description of Unplanned Element (SEUPDES) is not populated, the Element Code (ETCD) should not be equal to 'UNPLAN'. | Condition | ETCD equals 'UNPLAN' when SEUPDES is null |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Subject Visits
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SVSEQ | Sequence Number | float | 200 | |
| SVGRPID | Group ID | text | 200 | |
| SVREFID | Reference ID | text | 200 | |
| SVSPID | Sponsor-Defined Identifier | text | 200 | |
| VISITNUM | Visit Number |
|
float | 200 |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SVDTC | Date/Time of Collection | datetime | 200 | |
| SVSTDTC | Start Date/Time of Visit | datetime | 200 | |
| SVENDTC | End Date/Time of Visit | datetime | 200 | |
| SVDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| SVSTDY | Study Day of Start of Visit | integer | 200 | |
| SVENDY | Study Day of End of Visit | integer | 200 | |
| SVDUR | Duration | text | 200 | |
| SVTPT | Planned Time Point Name | text | 200 | |
| SVTPTNUM | Planned Time Point Number | float | 200 | |
| SVELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SVTPTREF | Time Point Reference | text | 200 | |
| SVRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SVSTRF | Start Relative to Reference Period | text | 200 | |
| SVENRF | End Relative to Reference Period | text | 200 | |
| SVEVLINT | Evaluation Interval | text | 200 | |
| SVEVINTX | Evaluation Interval Text | text | 200 | |
| SVSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SVSTTPT | Start Reference Time Point | text | 200 | |
| SVENRTPT | End Relative to Reference Time Point | text | 200 | |
| SVENTPT | End Reference Time Point | text | 200 | |
| SVSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| SVENINT | Planned End of Assessment Interval | datetime | 200 | |
| SVDETECT | Time in Days to Detection | integer | 200 | |
| SVUPDES | Description of Unplanned Visit | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1017 | Visit Number (VISITNUM) values should match entries in the Trial Visits (TV) dataset when they are planned visits (SVUPDES = NULL). | Lookup | VISITNUM value does not match TV domain data |
|
|
| SD1018 | The combination of Visit Number (VISITNUM), Visit Name (VISIT), and Planned Study Day of Visit (VISITDY) values should match entries in the Trial Visits (TV) dataset when they are planned visits (SVUPDES = NULL). | Lookup | VISITNUM/VISIT/VISITDY values do not match TV domain data |
|
|
| SD1019 | Planned Study Day of Visit (VISITDY) should equal NULL for unplanned visits, where Description of Unplanned Visit (SVUPDES) is populated. | Condition | VISITDY is populated for unplanned visit |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1060 | The value of Visit Number (VISITNUM) variable should be unique for each record within a subject. | Unique | Duplicate VISITNUM |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Interventions
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TRT | Name of Treatment |
|
text | 200 |
| __MODIFY | Modified Treatment Name | text | 200 | |
| __DECOD | Standardized Treatment Name | text | 200 | |
| __MOOD | Mood | text | 200 | |
| __CAT | Category | text | 200 | |
| __SCAT | Subcategory | text | 200 | |
| __PRESP | Pre-specified | text | 200 | |
| __OCCUR | Occurrence | text | 200 | |
| __STAT | Completion Status | text | 200 | |
| __REASND | Reason Not Done | text | 200 | |
| __INDC | Indication | text | 200 | |
| __CLAS | Class | text | 200 | |
| __CLASCD | Class Code | text | 200 | |
| __DOSE | Dose | float | 200 | |
| __DOSTXT | Dose Description | text | 200 | |
| __DOSU | Dose Units | text | 200 | |
| __DOSFRM | Dose Form | text | 200 | |
| __DOSFRQ | Dosing Frequency per Interval | text | 200 | |
| __DOSTOT | Total Daily Dose | float | 200 | |
| __DOSRGM | Intended Dose Regimen | text | 200 | |
| __ROUTE | Route of Administration | text | 200 | |
| __LOT | Lot Number | text | 200 | |
| __LOC | Location of Dose Administration | text | 200 | |
| __LAT | Laterality | text | 200 | |
| __DIR | Directionality | text | 200 | |
| __PORTOT | Portion or Totality | text | 200 | |
| __FAST | Fasting Status | text | 200 | |
| __PSTRG | Pharmaceutical Strength | float | 200 | |
| __PSTRGU | Pharmaceutical Strength Units | text | 200 | |
| __TRTV | Treatment Vehicle | text | 200 | |
| __VAMT | Treatment Vehicle Amount | float | 200 | |
| __VAMTU | Treatment Vehicle Amount Units | text | 200 | |
| __ADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| __DTC | Date/Time of Collection | datetime | 200 | |
| __STDTC | Start Date/Time of Observation | datetime | 200 | |
| __ENDTC | End Date/Time of Observation | datetime | 200 | |
| __DY | Study Day of Visit/Collection/Exam | integer | 200 | |
| __STDY | Study Day of Start of Observation | integer | 200 | |
| __ENDY | Study Day of End of Observation | integer | 200 | |
| __DUR | Duration | text | 200 | |
| __TPT | Planned Time Point Name | text | 200 | |
| __TPTNUM | Planned Time Point Number | float | 200 | |
| __ELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| __TPTREF | Time Point Reference | text | 200 | |
| __RFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| __STRF | Start Relative to Reference Period | text | 200 | |
| __ENRF | End Relative to Reference Period | text | 200 | |
| __EVLINT | Evaluation Interval | text | 200 | |
| __EVINTX | Evaluation Interval Text | text | 200 | |
| __STRTPT | Start Relative to Reference Time Point | text | 200 | |
| __STTPT | Start Reference Time Point | text | 200 | |
| __ENRTPT | End Relative to Reference Time Point | text | 200 | |
| __ENTPT | End Reference Time Point | text | 200 | |
| __STINT | Planned Start of Assessment Interval | datetime | 200 | |
| __ENINT | Planned End of Assessment Interval | datetime | 200 | |
| __DETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
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| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
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|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
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|
| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
|
|
| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
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|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
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| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Concomitant Medications
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| CMSEQ | Sequence Number |
|
float | 200 |
| CMGRPID | Group ID | text | 200 | |
| CMREFID | Reference ID | text | 200 | |
| CMSPID | Sponsor-Defined Identifier | text | 200 | |
| CMLNKID | Link ID | text | 200 | |
| CMLNKGRP | Link Group ID | text | 200 | |
| CMTRT | Reported Name of Drug, Med, or Therapy |
|
text | 200 |
| CMMODIFY | Modified Reported Name | text | 200 | |
| CMDECOD | Standardized Medication Name | text | 200 | |
| CMMOOD | Mood | text | 200 | |
| CMCAT | Category for Medication | text | 200 | |
| CMSCAT | Subcategory for Medication | text | 200 | |
| CMPRESP | CM Pre-Specified | text | 200 | |
| CMOCCUR | CM Occurrence | text | 200 | |
| CMSTAT | Completion Status | text | 200 | |
| CMREASND | Reason Medication Not Collected | text | 200 | |
| CMINDC | Indication | text | 200 | |
| CMCLAS | Medication Class | text | 200 | |
| CMCLASCD | Medication Class Code | text | 200 | |
| CMDOSE | Dose per Administration | float | 200 | |
| CMDOSTXT | Dose Description | text | 200 | |
| CMDOSU | Dose Units | text | 200 | |
| CMDOSFRM | Dose Form | text | 200 | |
| CMDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| CMDOSTOT | Total Daily Dose | float | 200 | |
| CMDOSRGM | Intended Dose Regimen | text | 200 | |
| CMROUTE | Route of Administration | text | 200 | |
| CMLOT | Lot Number | text | 200 | |
| CMLOC | Location of Dose Administration | text | 200 | |
| CMLAT | Laterality | text | 200 | |
| CMDIR | Directionality | text | 200 | |
| CMPORTOT | Portion or Totality | text | 200 | |
| CMFAST | Fasting Status | text | 200 | |
| CMPSTRG | Pharmaceutical Strength | float | 200 | |
| CMPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| CMTRTV | Treatment Vehicle | text | 200 | |
| CMVAMT | Treatment Vehicle Amount | float | 200 | |
| CMVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| CMADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| CMDTC | Date/Time of Collection | datetime | 200 | |
| CMSTDTC | Start Date/Time of Medication | datetime | 200 | |
| CMENDTC | End Date/Time of Medication | datetime | 200 | |
| CMDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| CMSTDY | Study Day of Start of Medication | integer | 200 | |
| CMENDY | Study Day of End of Medication | integer | 200 | |
| CMDUR | Duration of Medication | text | 200 | |
| CMTPT | Planned Time Point Name | text | 200 | |
| CMTPTNUM | Planned Time Point Number | float | 200 | |
| CMELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| CMTPTREF | Time Point Reference | text | 200 | |
| CMRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| CMSTRF | Start Relative to Reference Period | text | 200 | |
| CMENRF | End Relative to Reference Period | text | 200 | |
| CMEVLINT | Evaluation Interval | text | 200 | |
| CMEVINTX | Evaluation Interval Text | text | 200 | |
| CMSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| CMSTTPT | Start Reference Time Point | text | 200 | |
| CMENRTPT | End Relative to Reference Time Point | text | 200 | |
| CMENTPT | End Reference Time Point | text | 200 | |
| CMSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| CMENINT | Planned End of Assessment Interval | datetime | 200 | |
| CMDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
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| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
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| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
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| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
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| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
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| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
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| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
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| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
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| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
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| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
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| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
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| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
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| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
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| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
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| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
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| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
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| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
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| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
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| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
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| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
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| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
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| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
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| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
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| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1344 | Value for the Standardized Medication Name (--DECOD) variable must be populated using a Drug Name from the WHO Drug dictionary version specified in the define.xml. | Lookup | Value for %Domain%DECOD not found in WHODrug dictionary |
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| SD1345 | Value for the Medication Class (--CLAS) variable must be populated using ATC Text from the WHO Drug dictionary version specified in the define.xml. | Lookup | Value for %Domain%CLAS not found in WHODrug dictionary |
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| SD1346 | Value for the Medication Class Code (--CLASCD) variable must be populated using ATC Code from the WHO Drug dictionary version specified in the define.xml. | Lookup | Value for %Domain%CLASCD not found in WHODrug dictionary |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Device Exposure
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| DXSEQ | Sequence Number |
|
float | 200 |
| DXGRPID | Group ID | text | 200 | |
| DXREFID | Reference ID | text | 200 | |
| DXSPID | Sponsor-Defined Identifier | text | 200 | |
| DXLNKID | Link ID | text | 200 | |
| DXLNKGRP | Link Group ID | text | 200 | |
| DXTRT | Name of Device Exposure or Output |
|
text | 200 |
| DXMODIFY | Modified Treatment Name | text | 200 | |
| DXDECOD | Standardized Treatment Name | text | 200 | |
| DXMOOD | Mood | text | 200 | |
| DXCAT | Category for Device Exposure | text | 200 | |
| DXSCAT | Subcategory for Device Exposure | text | 200 | |
| DXPRESP | Pre-specified | text | 200 | |
| DXOCCUR | Occurrence | text | 200 | |
| DXSTAT | Completion Status | text | 200 | |
| DXREASND | Reason Not Done | text | 200 | |
| DXINDC | Indication | text | 200 | |
| DXCLAS | Class | text | 200 | |
| DXCLASCD | Class Code | text | 200 | |
| DXDOSE | Exposure per Administration | float | 200 | |
| DXDOSTXT | Device Exposure Description | text | 200 | |
| DXDOSU | Device Exposure Units | text | 200 | |
| DXDOSFRM | Dose Form | text | 200 | |
| DXDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| DXDOSTOT | Total Daily Device Exposure | float | 200 | |
| DXDOSRGM | Intended Device Exposure Regimen | text | 200 | |
| DXROUTE | Route of Administration | text | 200 | |
| DXLOT | Lot Number | text | 200 | |
| DXLOC | Location of Device Exposure | text | 200 | |
| DXLAT | Laterality of Device Exposure | text | 200 | |
| DXDIR | Directionality | text | 200 | |
| DXPORTOT | Portion or Totality | text | 200 | |
| DXFAST | Fasting Status | text | 200 | |
| DXPSTRG | Pharmaceutical Strength | float | 200 | |
| DXPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| DXTRTV | Treatment Vehicle | text | 200 | |
| DXVAMT | Treatment Vehicle Amount | float | 200 | |
| DXVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| DXADJ | Reason for Exposure Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DXDTC | Date/Time of Collection | datetime | 200 | |
| DXSTDTC | Start Date/Time of Device Exposure | datetime | 200 | |
| DXENDTC | End Date/Time of Device Exposure | datetime | 200 | |
| DXDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DXSTDY | Study Day of Start of Device Exposure | integer | 200 | |
| DXENDY | Study Day of End of Device Exposure | integer | 200 | |
| DXDUR | Duration of Device Exposure | text | 200 | |
| DXTPT | Planned Time Point Name | text | 200 | |
| DXTPTNUM | Planned Time Point Number | float | 200 | |
| DXELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DXTPTREF | Time Point Reference | text | 200 | |
| DXRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DXSTRF | Start Relative to Reference Period | text | 200 | |
| DXENRF | End Relative to Reference Period | text | 200 | |
| DXEVLINT | Evaluation Interval | text | 200 | |
| DXEVINTX | Evaluation Interval Text | text | 200 | |
| DXSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DXSTTPT | Start Reference Time Point | text | 200 | |
| DXENRTPT | End Relative to Reference Time Point | text | 200 | |
| DXENTPT | End Reference Time Point | text | 200 | |
| DXSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DXENINT | Planned End of Assessment Interval | datetime | 200 | |
| DXDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1236 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each combination of Sponsor Device Identifier (SPDEVID) and Unique Subject Identifier (USUBJID) variables' values. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
|
|
| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
|
|
| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Exposure as Collected
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| ECSEQ | Sequence Number |
|
float | 200 |
| ECGRPID | Group ID | text | 200 | |
| ECREFID | Reference ID | text | 200 | |
| ECSPID | Sponsor-Defined Identifier | text | 200 | |
| ECLNKID | Link ID | text | 200 | |
| ECLNKGRP | Link Group ID | text | 200 | |
| ECTRT | Name of Treatment |
|
text | 200 |
| ECMODIFY | Modified Treatment Name | text | 200 | |
| ECDECOD | Standardized Treatment Name | text | 200 | |
| ECMOOD | Mood | text | 200 | |
| ECCAT | Category of Treatment | text | 200 | |
| ECSCAT | Subcategory of Treatment | text | 200 | |
| ECPRESP | Pre-Specified | text | 200 | |
| ECOCCUR | Occurrence | text | 200 | |
| ECSTAT | Completion Status | text | 200 | |
| ECREASND | Reason Not Done | text | 200 | |
| ECINDC | Indication | text | 200 | |
| ECCLAS | Class | text | 200 | |
| ECCLASCD | Class Code | text | 200 | |
| ECDOSE | Dose | float | 200 | |
| ECDOSTXT | Dose Description | text | 200 | |
| ECDOSU | Dose Units | text | 200 | |
| ECDOSFRM | Dose Form | text | 200 | |
| ECDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| ECDOSTOT | Total Daily Dose | float | 200 | |
| ECDOSRGM | Intended Dose Regimen | text | 200 | |
| ECROUTE | Route of Administration | text | 200 | |
| ECLOT | Lot Number | text | 200 | |
| ECLOC | Location of Dose Administration | text | 200 | |
| ECLAT | Laterality | text | 200 | |
| ECDIR | Directionality | text | 200 | |
| ECPORTOT | Portion or Totality | text | 200 | |
| ECFAST | Fasting Status | text | 200 | |
| ECPSTRG | Pharmaceutical Strength | float | 200 | |
| ECPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| ECTRTV | Treatment Vehicle | text | 200 | |
| ECVAMT | Treatment Vehicle Amount | float | 200 | |
| ECVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| ECADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| ECDTC | Date/Time of Collection | datetime | 200 | |
| ECSTDTC | Start Date/Time of Treatment | datetime | 200 | |
| ECENDTC | End Date/Time of Treatment | datetime | 200 | |
| ECDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| ECSTDY | Study Day of Start of Treatment | integer | 200 | |
| ECENDY | Study Day of End of Treatment | integer | 200 | |
| ECDUR | Duration of Treatment | text | 200 | |
| ECTPT | Planned Time Point Name | text | 200 | |
| ECTPTNUM | Planned Time Point Number | float | 200 | |
| ECELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| ECTPTREF | Time Point Reference | text | 200 | |
| ECRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| ECSTRF | Start Relative to Reference Period | text | 200 | |
| ECENRF | End Relative to Reference Period | text | 200 | |
| ECEVLINT | Evaluation Interval | text | 200 | |
| ECEVINTX | Evaluation Interval Text | text | 200 | |
| ECSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| ECSTTPT | Start Reference Time Point | text | 200 | |
| ECENRTPT | End Relative to Reference Time Point | text | 200 | |
| ECENTPT | End Reference Time Point | text | 200 | |
| ECSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| ECENINT | Planned End of Assessment Interval | datetime | 200 | |
| ECDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1135 | Study Day variables (*DY) value should not be negative in Exposure (EX) and Exposure As Collected (EC) datasets. | Regex | Negative value of %Variable% Study Day variable |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1247 | ECDOSE must be greater than zero when ECOCCUR does not equal 'N', ECSTAT does not equal 'NOT DONE', and ECDOSTXT is null. ECDOSE must not be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed. | Condition | ECDOSE is not greater than 0 when ECOCCUR does not equal 'N' and ECDOSTXT is null |
|
|
| SD1248 | ECDOSE must either be null when ECOCCUR equals 'N', or ECDOSE must be greater than 0. ECDOSE would be greater than 0 (when ECOCCUR equals N) for records that represent specific dose amounts that are not taken, not given, or missed. | Condition | ECDOSE is not null or greater than 0 when ECOCCUR = 'N' |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
|
|
| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
|
|
| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
|
|
| SD1279 | Dose Description (ECDOSTXT) should be populated when Dose (ECDOSE) is null, ECOCCUR does not equal 'N', and ECSTAT does not equal 'NOT DONE'. | Condition | ECDOSTXT is null when ECDOSE is null and ECOCCUR does not equal 'N' |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1352 | The structure of Interventions class domains should be one record per Intervention Episode per subject. No Interventions with the same Treatment (--TRT), Decoded Term (--DECOD), Mood (--MOOD), Category (--CAT), Subcategory (--SCAT), Route (--ROUTE), Location (--LOC) and Treatment Vehicle (--TRTV) values for the same Subject (USUBJID) with the same Start Date (--STDTC), Planned Time Point Name (--TPT), and Planned Time Point Number (--TPTNUM) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Exposure
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| EXSEQ | Sequence Number |
|
float | 200 |
| EXGRPID | Group ID | text | 200 | |
| EXREFID | Reference ID | text | 200 | |
| EXSPID | Sponsor-Defined Identifier | text | 200 | |
| EXLNKID | Link ID | text | 200 | |
| EXLNKGRP | Link Group ID | text | 200 | |
| EXTRT | Name of Treatment |
|
text | 200 |
| EXMODIFY | Modified Treatment Name | text | 200 | |
| EXDECOD | Standardized Treatment Name | text | 200 | |
| EXMOOD | Mood | text | 200 | |
| EXCAT | Category of Treatment | text | 200 | |
| EXSCAT | Subcategory of Treatment | text | 200 | |
| EXPRESP | Pre-specified | text | 200 | |
| EXOCCUR | Occurrence | text | 200 | |
| EXSTAT | Completion Status | text | 200 | |
| EXREASND | Reason Not Done | text | 200 | |
| EXINDC | Indication | text | 200 | |
| EXCLAS | Class | text | 200 | |
| EXCLASCD | Class Code | text | 200 | |
| EXDOSE | Dose | float | 200 | |
| EXDOSTXT | Dose Description | text | 200 | |
| EXDOSU | Dose Units | text | 200 | |
| EXDOSFRM | Dose Form | text | 200 | |
| EXDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| EXDOSTOT | Total Daily Dose | float | 200 | |
| EXDOSRGM | Intended Dose Regimen | text | 200 | |
| EXROUTE | Route of Administration | text | 200 | |
| EXLOT | Lot Number | text | 200 | |
| EXLOC | Location of Dose Administration | text | 200 | |
| EXLAT | Laterality | text | 200 | |
| EXDIR | Directionality | text | 200 | |
| EXPORTOT | Portion or Totality | text | 200 | |
| EXFAST | Fasting Status | text | 200 | |
| EXPSTRG | Pharmaceutical Strength | float | 200 | |
| EXPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| EXTRTV | Treatment Vehicle | text | 200 | |
| EXVAMT | Treatment Vehicle Amount | float | 200 | |
| EXVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| EXADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| EXDTC | Date/Time of Collection | datetime | 200 | |
| EXSTDTC | Start Date/Time of Treatment | datetime | 200 | |
| EXENDTC | End Date/Time of Treatment | datetime | 200 | |
| EXDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| EXSTDY | Study Day of Start of Treatment | integer | 200 | |
| EXENDY | Study Day of End of Treatment | integer | 200 | |
| EXDUR | Duration of Treatment | text | 200 | |
| EXTPT | Planned Time Point Name | text | 200 | |
| EXTPTNUM | Planned Time Point Number | float | 200 | |
| EXELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| EXTPTREF | Time Point Reference | text | 200 | |
| EXRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| EXSTRF | Start Relative to Reference Period | text | 200 | |
| EXENRF | End Relative to Reference Period | text | 200 | |
| EXEVLINT | Evaluation Interval | text | 200 | |
| EXEVINTX | Evaluation Interval Text | text | 200 | |
| EXSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| EXSTTPT | Start Reference Time Point | text | 200 | |
| EXENRTPT | End Relative to Reference Time Point | text | 200 | |
| EXENTPT | End Reference Time Point | text | 200 | |
| EXSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| EXENINT | Planned End of Assessment Interval | datetime | 200 | |
| EXDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD0079 | Subjects that are not assigned to an Arm (ARMCD='NOTASSGN') or are screen failures (ARMCD='SCRNFAIL'), or ARM=null, should not have any Exposure records. Run-in records (EPOCH='RUN-IN') are excluded from firing for this validation rule. | Lookup | EX record is present when subject is not assigned to an arm |
|
|
| SD0082 | End Date/Time of Treatment (EXENDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). Investigator should provide a date of study discontinuation for each subject in Disposition (DS) domain. | Condition | Exposure end date is after the latest Disposition date |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
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| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1135 | Study Day variables (*DY) value should not be negative in Exposure (EX) and Exposure As Collected (EC) datasets. | Regex | Negative value of %Variable% Study Day variable |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1205 | Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of First Study Treatment (RFXSTDTC). | Condition | EXSTDTC date is before RFXSTDTC |
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| SD1206 | Start Date/Time of Treatment (EXSTDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC). | Condition | EXSTDTC date is after RFXENDTC |
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| SD1207 | End Date/Time of Treatment (EXENDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC). | Condition | EXENDTC date is after RFXENDTC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1249 | EXDOSE must be equal to 0 when EXTRT = 'PLACEBO'. | Condition | EXDOSE does not equal 0 when EXTRT = 'PLACEBO' |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
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| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
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| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1340 | Subjects that are not treated (ACTARMCD='NOTTRT' or null) should not have any Exposure records. Run-in records (EPOCH='RUN-IN') are excluded from firing for this validation rule. | Lookup | EX record is present when subject is not treated |
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| SD1352 | The structure of Interventions class domains should be one record per Intervention Episode per subject. No Interventions with the same Treatment (--TRT), Decoded Term (--DECOD), Mood (--MOOD), Category (--CAT), Subcategory (--SCAT), Route (--ROUTE), Location (--LOC) and Treatment Vehicle (--TRTV) values for the same Subject (USUBJID) with the same Start Date (--STDTC), Planned Time Point Name (--TPT), and Planned Time Point Number (--TPTNUM) are expected. | Unique | Duplicate records in %Domain% domain |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1446 | Start Date/Time of Treatment (EXSTDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | Exposure start date is after the latest Disposition date |
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| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
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Procedures
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| PRSEQ | Sequence Number |
|
float | 200 |
| PRGRPID | Group ID | text | 200 | |
| PRREFID | Reference ID | text | 200 | |
| PRSPID | Sponsor-Defined Identifier | text | 200 | |
| PRLNKID | Link ID | text | 200 | |
| PRLNKGRP | Link Group ID | text | 200 | |
| PRTRT | Reported Name of Procedure |
|
text | 200 |
| PRMODIFY | Modified Treatment Name | text | 200 | |
| PRDECOD | Standardized Procedure Name | text | 200 | |
| PRMOOD | Mood | text | 200 | |
| PRCAT | Category | text | 200 | |
| PRSCAT | Subcategory | text | 200 | |
| PRPRESP | Pre-specified | text | 200 | |
| PROCCUR | Occurrence | text | 200 | |
| PRSTAT | Completion Status | text | 200 | |
| PRREASND | Reason Not Done | text | 200 | |
| PRINDC | Indication | text | 200 | |
| PRCLAS | Class | text | 200 | |
| PRCLASCD | Class Code | text | 200 | |
| PRDOSE | Dose | float | 200 | |
| PRDOSTXT | Dose Description | text | 200 | |
| PRDOSU | Dose Units | text | 200 | |
| PRDOSFRM | Dose Form | text | 200 | |
| PRDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| PRDOSTOT | Total Daily Dose | float | 200 | |
| PRDOSRGM | Intended Dose Regimen | text | 200 | |
| PRROUTE | Route of Administration | text | 200 | |
| PRLOT | Lot Number | text | 200 | |
| PRLOC | Location of Procedure | text | 200 | |
| PRLAT | Laterality | text | 200 | |
| PRDIR | Directionality | text | 200 | |
| PRPORTOT | Portion or Totality | text | 200 | |
| PRFAST | Fasting Status | text | 200 | |
| PRPSTRG | Pharmaceutical Strength | float | 200 | |
| PRPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| PRTRTV | Treatment Vehicle | text | 200 | |
| PRVAMT | Treatment Vehicle Amount | float | 200 | |
| PRVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| PRADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PRDTC | Date/Time of Collection | datetime | 200 | |
| PRSTDTC | Start Date/Time of Procedure | datetime | 200 | |
| PRENDTC | End Date/Time of Procedure | datetime | 200 | |
| PRDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| PRSTDY | Study Day of Start of Procedure | integer | 200 | |
| PRENDY | Study Day of End of Procedure | integer | 200 | |
| PRDUR | Duration of Procedure | text | 200 | |
| PRTPT | Planned Time Point Name | text | 200 | |
| PRTPTNUM | Planned Time Point Number | float | 200 | |
| PRELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| PRTPTREF | Time Point Reference | text | 200 | |
| PRRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| PRSTRF | Start Relative to Reference Period | text | 200 | |
| PRENRF | End Relative to Reference Period | text | 200 | |
| PREVLINT | Evaluation Interval | text | 200 | |
| PREVINTX | Evaluation Interval Text | text | 200 | |
| PRSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| PRSTTPT | Start Reference Time Point | text | 200 | |
| PRENRTPT | End Relative to Reference Time Point | text | 200 | |
| PRENTPT | End Reference Time Point | text | 200 | |
| PRSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| PRENINT | Planned End of Assessment Interval | datetime | 200 | |
| PRDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
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| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
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| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
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| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
|
|
| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
|
|
| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Substance Use
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| SUSEQ | Sequence Number |
|
float | 200 |
| SUGRPID | Group ID | text | 200 | |
| SUREFID | Reference ID | text | 200 | |
| SUSPID | Sponsor-Defined Identifier | text | 200 | |
| SULNKID | Link ID | text | 200 | |
| SULNKGRP | Link Group ID | text | 200 | |
| SUTRT | Reported Name of Substance |
|
text | 200 |
| SUMODIFY | Modified Substance Name | text | 200 | |
| SUDECOD | Standardized Substance Name | text | 200 | |
| SUMOOD | Mood | text | 200 | |
| SUCAT | Category for Substance Use | text | 200 | |
| SUSCAT | Subcategory for Substance Use | text | 200 | |
| SUPRESP | SU Pre-Specified | text | 200 | |
| SUOCCUR | SU Occurrence | text | 200 | |
| SUSTAT | Completion Status | text | 200 | |
| SUREASND | Reason Substance Use Not Collected | text | 200 | |
| SUINDC | Indication | text | 200 | |
| SUCLAS | Substance Use Class | text | 200 | |
| SUCLASCD | Substance Use Class Code | text | 200 | |
| SUDOSE | Substance Use Consumption | float | 200 | |
| SUDOSTXT | Substance Use Consumption Text | text | 200 | |
| SUDOSU | Consumption Units | text | 200 | |
| SUDOSFRM | Dose Form | text | 200 | |
| SUDOSFRQ | Use Frequency Per Interval | text | 200 | |
| SUDOSTOT | Total Daily Consumption | float | 200 | |
| SUDOSRGM | Intended Dose Regimen | text | 200 | |
| SUROUTE | Route of Administration | text | 200 | |
| SULOT | Lot Number | text | 200 | |
| SULOC | Location of Dose Administration | text | 200 | |
| SULAT | Laterality | text | 200 | |
| SUDIR | Directionality | text | 200 | |
| SUPORTOT | Portion or Totality | text | 200 | |
| SUFAST | Fasting Status | text | 200 | |
| SUPSTRG | Pharmaceutical Strength | float | 200 | |
| SUPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| SUTRTV | Treatment Vehicle | text | 200 | |
| SUVAMT | Treatment Vehicle Amount | float | 200 | |
| SUVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| SUADJ | Reason for Dose Adjustment | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SUDTC | Date/Time of Collection | datetime | 200 | |
| SUSTDTC | Start Date/Time of Substance Use | datetime | 200 | |
| SUENDTC | End Date/Time of Substance Use | datetime | 200 | |
| SUDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| SUSTDY | Study Day of Start of Substance Use | integer | 200 | |
| SUENDY | Study Day of End of Substance Use | integer | 200 | |
| SUDUR | Duration of Substance Use | text | 200 | |
| SUTPT | Planned Time Point Name | text | 200 | |
| SUTPTNUM | Planned Time Point Number | float | 200 | |
| SUELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SUTPTREF | Time Point Reference | text | 200 | |
| SURFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SUSTRF | Start Relative to Reference Period | text | 200 | |
| SUENRF | End Relative to Reference Period | text | 200 | |
| SUEVLINT | Evaluation Interval | text | 200 | |
| SUEVINTX | Evaluation Interval Text | text | 200 | |
| SUSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SUSTTPT | Start Reference Time Point | text | 200 | |
| SUENRTPT | End Relative to Reference Time Point | text | 200 | |
| SUENTPT | End Reference Time Point | text | 200 | |
| SUSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| SUENINT | Planned End of Assessment Interval | datetime | 200 | |
| SUDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0014 | Non-missing Dose (--DOSE) value must be greater than or equal to 0. | Condition | Negative value for %Domain%DOSE |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0035 | Dose Units (--DOSU) must be populated when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided. | Required | Missing value for %Domain%DOSU when %Domain%DOSE, %Domain%DOSTXT or %Domain%DOSTOT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0043 | Treatment Vehicle (--TRTV) should be provided when Treatment Vehicle Amount (--VAMT) is specified. | Required | Missing value for %Domain%TRTV when %Domain%VAMT is not NULL |
|
|
| SD0044 | Treatment Vehicle Amount Units (--VAMTU) should not be NULL when Treatment Vehicle Amount (--VAMT) is populated. | Required | Missing value for %Domain%VAMTU when %Domain%VAMT is populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1047 | Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record. | Condition | Both %Domain%DOSE and %Domain%DOSTXT values are populated |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1251 | Treatment Vehicle Amount Units (--VAMTU) value must be null when Treatment Vehicle Amount (--TRTV) value is null. | Condition | %Domain%VAMTU is not null when %Domain%TRTV is null |
|
|
| SD1273 | Name of Treatment variables (--TRT) should not be populated with values of 'OTHER'. | Condition | %Domain%TRT equals 'OTHER' |
|
|
| SD1276 | Name of Treatment variables (--TRT) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TRT equals 'MULTIPLE' |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1452 | Non-missing Treatment Vehicle Amount (--VAMT) value must be greater than or equal to 0. | Condition | Negative value for %Domain%VAMT |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TERM | Reported Term |
|
text | 200 |
| __MODIFY | Modified Reported Term | text | 200 | |
| __LLT | Lowest Level Term | text | 200 | |
| __LLTCD | Lowest Level Term Code | integer | 200 | |
| __DECOD | Dictionary-Derived Term | text | 200 | |
| __PTCD | Preferred Term Code | integer | 200 | |
| __HLT | High Level Term | text | 200 | |
| __HLTCD | High Level Term Code | integer | 200 | |
| __HLGT | High Level Group Term | text | 200 | |
| __HLGTCD | High Level Group Term Code | integer | 200 | |
| __CAT | Category | text | 200 | |
| __SCAT | Subcategory | text | 200 | |
| __PRESP | Pre-specified | text | 200 | |
| __OCCUR | Occurrence | text | 200 | |
| __STAT | Completion Status | text | 200 | |
| __REASND | Reason Not Done | text | 200 | |
| __BODSYS | Body System or Organ Class | text | 200 | |
| __BDSYCD | Body System or Organ Class Code | integer | 200 | |
| __SOC | Primary System Organ Class | text | 200 | |
| __SOCCD | Primary System Organ Class Code | integer | 200 | |
| __LOC | Location of Event | text | 200 | |
| __LAT | Laterality | text | 200 | |
| __DIR | Directionality | text | 200 | |
| __PORTOT | Portion or Totality | text | 200 | |
| __PARTY | Accountable Party | text | 200 | |
| __PRTYID | Identification of Accountable Party | text | 200 | |
| __SEV | Severity/Intensity | text | 200 | |
| __SER | Serious Event | text | 200 | |
| __ACN | Action Taken with Study Treatment | text | 200 | |
| __ACNOTH | Other Action Taken | text | 200 | |
| __ACNDEV | Action Taken with Device | text | 200 | |
| __REL | Causality | text | 200 | |
| __RELNST | Relationship to Non-Study Treatment | text | 200 | |
| __PATT | Pattern of Event | text | 200 | |
| __OUT | Outcome of Event | text | 200 | |
| __SCAN | Involves Cancer | text | 200 | |
| __SCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| __SDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| __SDTH | Results in Death | text | 200 | |
| __SHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| __SLIFE | Is Life Threatening | text | 200 | |
| __SOD | Occurred with Overdose | text | 200 | |
| __SMIE | Other Medically Important Serious Event | text | 200 | |
| __CONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| __TOX | Toxicity | text | 200 | |
| __TOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| __DTC | Date/Time of Collection | datetime | 200 | |
| __STDTC | Start Date/Time of Observation | datetime | 200 | |
| __ENDTC | End Date/Time of Observation | datetime | 200 | |
| __DY | Study Day of Visit/Collection/Exam | integer | 200 | |
| __STDY | Study Day of Start of Observation | integer | 200 | |
| __ENDY | Study Day of End of Observation | integer | 200 | |
| __DUR | Duration | text | 200 | |
| __TPT | Planned Time Point Name | text | 200 | |
| __TPTNUM | Planned Time Point Number | float | 200 | |
| __ELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| __TPTREF | Time Point Reference | text | 200 | |
| __RFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| __STRF | Start Relative to Reference Period | text | 200 | |
| __ENRF | End Relative to Reference Period | text | 200 | |
| __EVLINT | Evaluation Interval | text | 200 | |
| __EVINTX | Evaluation Interval Text | text | 200 | |
| __STRTPT | Start Relative to Reference Time Point | text | 200 | |
| __STTPT | Start Reference Time Point | text | 200 | |
| __ENRTPT | End Relative to Reference Time Point | text | 200 | |
| __ENTPT | End Reference Time Point | text | 200 | |
| __STINT | Planned Start of Assessment Interval | datetime | 200 | |
| __ENINT | Planned End of Assessment Interval | datetime | 200 | |
| __DETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
|
|
| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Adverse Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| AESEQ | Sequence Number |
|
float | 200 |
| AEGRPID | Group ID | text | 200 | |
| AEREFID | Reference ID | text | 200 | |
| AESPID | Sponsor-Defined Identifier | text | 200 | |
| AELNKID | Link ID | text | 200 | |
| AELNKGRP | Link Group ID | text | 200 | |
| AETERM | Reported Term for the Adverse Event |
|
text | 200 |
| AEMODIFY | Modified Reported Term | text | 200 | |
| AELLT | Lowest Level Term | text | 200 | |
| AELLTCD | Lowest Level Term Code | integer | 200 | |
| AEDECOD | Dictionary-Derived Term |
|
text | 200 |
| AEPTCD | Preferred Term Code | integer | 200 | |
| AEHLT | High Level Term | text | 200 | |
| AEHLTCD | High Level Term Code | integer | 200 | |
| AEHLGT | High Level Group Term | text | 200 | |
| AEHLGTCD | High Level Group Term Code | integer | 200 | |
| AECAT | Category for Adverse Event | text | 200 | |
| AESCAT | Subcategory for Adverse Event | text | 200 | |
| AEPRESP | Pre-Specified Adverse Event | text | 200 | |
| AEOCCUR | Occurrence | text | 200 | |
| AESTAT | Completion Status | text | 200 | |
| AEREASND | Reason Not Done | text | 200 | |
| AEBODSYS | Body System or Organ Class | text | 200 | |
| AEBDSYCD | Body System or Organ Class Code | integer | 200 | |
| AESOC | Primary System Organ Class | text | 200 | |
| AESOCCD | Primary System Organ Class Code | integer | 200 | |
| AELOC | Location of Event | text | 200 | |
| AELAT | Laterality | text | 200 | |
| AEDIR | Directionality | text | 200 | |
| AEPORTOT | Portion or Totality | text | 200 | |
| AEPARTY | Accountable Party | text | 200 | |
| AEPRTYID | Identification of Accountable Party | text | 200 | |
| AESEV | Severity/Intensity | text | 200 | |
| AESER | Serious Event | text | 200 | |
| AEACN | Action Taken with Study Treatment | text | 200 | |
| AEACNOTH | Other Action Taken | text | 200 | |
| AEACNDEV | Action Taken with Device | text | 200 | |
| AEREL | Causality | text | 200 | |
| AERELNST | Relationship to Non-Study Treatment | text | 200 | |
| AEPATT | Pattern of Adverse Event | text | 200 | |
| AEOUT | Outcome of Adverse Event | text | 200 | |
| AESCAN | Involves Cancer | text | 200 | |
| AESCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| AESDTH | Results in Death | text | 200 | |
| AESHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| AESLIFE | Is Life Threatening | text | 200 | |
| AESOD | Occurred with Overdose | text | 200 | |
| AESMIE | Other Medically Important Serious Event | text | 200 | |
| AECONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| AETOX | Toxicity | text | 200 | |
| AETOXGR | Standard Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| AEDTC | Date/Time of Collection | datetime | 200 | |
| AESTDTC | Start Date/Time of Adverse Event | datetime | 200 | |
| AEENDTC | End Date/Time of Adverse Event | datetime | 200 | |
| AEDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| AESTDY | Study Day of Start of Adverse Event | integer | 200 | |
| AEENDY | Study Day of End of Adverse Event | integer | 200 | |
| AEDUR | Duration of Adverse Event | text | 200 | |
| AETPT | Planned Time Point Name | text | 200 | |
| AETPTNUM | Planned Time Point Number | float | 200 | |
| AEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| AETPTREF | Time Point Reference | text | 200 | |
| AERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| AESTRF | Start Relative to Reference Period | text | 200 | |
| AEENRF | End Relative to Reference Period | text | 200 | |
| AEEVLINT | Evaluation Interval | text | 200 | |
| AEEVINTX | Evaluation Interval Text | text | 200 | |
| AESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| AESTTPT | Start Reference Time Point | text | 200 | |
| AEENRTPT | End Relative to Reference Time Point | text | 200 | |
| AEENTPT | End Reference Time Point | text | 200 | |
| AESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| AEENINT | Planned End of Assessment Interval | datetime | 200 | |
| AEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0008 | Value for the Dictionary-Derived Term (--DECOD) variable must be populated using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%DECOD not found in MedDRA dictionary |
|
|
| SD0008C | Case for the Dictionary-Derived Term (--DECOD) variable must be sentence case using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%DECOD is in incorrect case |
|
|
| SD0009 | When Serious Event (AESER) variable value is 'Y', then at least one of seriousness criteria variables is expected to have value 'Y' (Involves Cancer (AESCAN), Congenital Anomaly or Birth Defect (AESCONG), Persist or Signif Disability/Incapacity (AESDISAB), Results in Death (AESDTH), Requires or Prolongs Hospitalization (AESHOSP), Is Life Threatening (AESLIFE), or Other Medically Important Serious Event (AESMIE)). | Condition | No qualifiers set to 'Y' when AE is Serious |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD0080 | Start Date/Time of Adverse Event (AESTDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). Investigator should provide a date of study discontinuation for each subject in Disposition (DS) domain. | Condition | AE start date is after the latest Disposition date |
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| SD0090 | Results in Death (AESDTH) should equal 'Y' when Outcome of Adverse Event (AEOUT) is 'FATAL'. | Condition | AESDTH is not 'Y' when AEOUT='FATAL' |
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| SD0091 | Outcome of Adverse Event should equal 'FATAL' when Results in Death (AESDTH) is 'Y'. | Condition | AEOUT is not 'FATAL' when AESDTH='Y' |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
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| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
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| SD1062 | Serious Event (AESER) variable value is expected to be 'Y' when Occurred with Overdose (AESOD) variable value equals 'Y'. | Condition | AESER is not 'Y' when AESOD equals 'Y' |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
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| SD1097 | A treatment-emergent flag should be included in SUPPAE according to the FDA business rule that states, 'A treatment-emergent flag should be submitted'. | Lookup | No Treatment Emergent info for Adverse Event |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1114 | Value for Body System or Organ Class (--BODSYS) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%BODSYS not found in MedDRA dictionary |
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| SD1114C | Case for Body System or Organ Class (--BODSYS) variable must follow MedDRA sentence case and be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%BODSYS is in incorrect case |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1132 | Serious Event (AESER) variable value is expected to be 'Y' when either of Seriousness Criteria variables (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESMIE) has value 'Y'. | Condition | AESER is not 'Y' |
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| SD1143 | When a description of Other Medically Important Serious Adverse Events category is collected on a CRF, sponsors should place the description in the SUPPAE dataset using the standard supplemental qualifier name code AESOSP. | Lookup | No Details info for AESMIE Adverse Event in SUPPAE domain |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1241 | Body System or Organ Class (--BODSYS) must be populated when Body System or Organ Class Code (--BDSYCD) is populated. | Condition | %Domain%BODSYS is not populated when %Domain%BDSYCD is populated |
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| SD1242 | All values of Body System or Organ Class (--BODSYS) should be the same for a given value of Body System or Organ Class Code (--BDSYCD). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%BDSYCD |
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| SD1243 | All values of Body System or Organ Class Code (--BDSYCD) should be the same for a given value of Body System or Organ Class (--BODSYS). | Unique | Inconsistent value for %Domain%BDSYCD within %Domain%BODSYS |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1254 | DTHFL must equal 'Y' when there is a record in the Adverse Events (AE) domain with AEOUT = 'FATAL'. | Lookup | DTHFL does not equal 'Y' when AE.AEOUT = 'FATAL' |
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| SD1255 | DTHFL must equal 'Y' when there is a record in the Adverse Events (AE) domain with AESDTH = 'Y'. | Lookup | DTHFL does not equal 'Y' when AE.AESDTH = 'Y' |
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| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
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| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
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| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
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| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
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| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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| SD1332 | The Outcome of Adverse Event (AEOUT) variable is populated with the value NOT RECOVERED/NOT RESOLVED, however the End Date/Time of Adverse Event (AEENDTC) variable is populated with an end date for the adverse event. If the adverse event has an outcome of NOT RECOVERED/NOT RESOLVED, it is expected that no end date is available. | Condition | AEOUT = NOT RECOVERED/NOT RESOLVED, but an end date is provided |
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| SD1333 | The Outcome of Adverse Event (AEOUT) variable is populated with the value RECOVERED/RESOLVED, however the End Date/Time of Adverse Event (AEENDTC) or Duration of Adverse Event (AEDUR) variables are null. If the adverse event has an outcome of RECOVERED/RESOLVED, it is expected that an end date or a collected duration be provided. | Condition | AEOUT = RECOVERED/RESOLVED, but an end date or collected duration is not provided |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1347 | Fatal Adverse Event records (AEOUT = 'FATAL') in the Adverse Events (AE) domain should have End Date/Time of Adverse Event (AEENDTC) equal to subject's Date/Time of Death (DTHDTC) populated in the Demographics (DM) domain. Subject's Date/Time of Death info should be consistent across all domains. | Condition | AEENDTC for fatal AE is not the same as DM.DTHDTC |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1440 | MedDRA coding Preferred Term (--DECOD) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%DECOD within %Domain%TERM |
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| SD1441 | MedDRA coding High Level Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLT within %Domain%TERM |
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| SD1442 | MedDRA coding High Level Group Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLGT within %Domain%TERM |
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| SD1443 | Body System (--BODSYS) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%TERM |
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| SD1444 | MedDRA System Organ Class (--SOC) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%SOC within %Domain%TERM |
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| SD1449 | Reported Term for the Adverse Event (AETERM) is expected to be coded using the Medical Dictionary for Regulatory Affairs (MedDRA). Sponsors should code each term to the MedDRA-specified hierarchy of terms. These terms/codes are represented in SDTM variables that are subject to MedDRA: AELLT, AELLTCD, AEDECOD, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLGTCD, AEBODSYS, AEBDSYCD, AESOC, AESOCCD. | Condition | Missing values for one or more variables subject to MedDRA: %Domain%LLT, %Domain%LLTCD, %Domain%DECOD, %Domain%PTCD, %Domain%HLT, %Domain%HLTCD, %Domain%HLGT, %Domain%HLGTCD, %Domain%BODSYS, %Domain%BDSYCD, %Domain%SOC, %Domain%SOCCD |
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| SD2007 | Value for Preferred Term Code (--PTCD) variable must be populated using a Preferred Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%PTCD not found in MedDRA dictionary |
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| SD2008 | Value for Lowest Level Term (--LLT) variable must be populated using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%LLT not found in MedDRA dictionary |
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| SD2008C | Case for Lowest Level Term (--LLT) variable must be sentence case using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%LLT is in incorrect case |
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| SD2009 | Value for Lowest Level Term Code (--LLTCD) variable must be populated using a Lowest Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%LLTCD not found in MedDRA dictionary |
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| SD2010 | Value for High Level Term (--HLT) variable must be populated using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLT not found in MedDRA dictionary |
|
|
| SD2010C | Case for High Level Term (--HLT) variable must be sentence case using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLT is in incorrect case |
|
|
| SD2011 | Value for High Level Term Code (--HLTCD) variable must be populated using a High Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLTCD not found in MedDRA dictionary |
|
|
| SD2012 | Value for High Level Group Term (--HLGT) variable must be populated using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLGT not found in MedDRA dictionary |
|
|
| SD2012C | Case for High Level Group Term (--HLGT) variable must be sentence case using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLGT is in incorrect case |
|
|
| SD2013 | Value for High Level Group Term Code (--HLGTCD) variable must be populated using a High Level Group Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLGTCD not found in MedDRA dictionary |
|
|
| SD2014 | Value for Body System or Organ Class Code (--BDSYCD) variable should be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%BDSYCD not found in MedDRA dictionary |
|
|
| SD2015 | Value for System Organ Class (--SOC) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%SOC not found in MedDRA dictionary |
|
|
| SD2015C | Case for System Organ Class (--SOC) variable must be sentence case using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%SOC is in incorrect case |
|
|
| SD2016 | Value for System Organ Class Code (--SOCCD) variable must be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%SOCCD not found in MedDRA dictionary |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Associated Persons Adverse Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| APID | Associated Persons Identifier |
|
text | 200 |
| AESEQ | Sequence Number |
|
float | 200 |
| RSUBJID | Related Subject | text | 200 | |
| RDEVID | Related Device Identifier | text | 200 | |
| SREL | Subject, Device, or Study Relationship |
|
text | 200 |
| AEGRPID | Group ID | text | 200 | |
| AEREFID | Reference ID | text | 200 | |
| AESPID | Sponsor-Defined Identifier | text | 200 | |
| AELNKID | Link ID | text | 200 | |
| AELNKGRP | Link Group ID | text | 200 | |
| AETERM | Reported Term for the Adverse Event |
|
text | 200 |
| AEMODIFY | Modified Reported Term | text | 200 | |
| AELLT | Lowest Level Term | text | 200 | |
| AELLTCD | Lowest Level Term Code | integer | 200 | |
| AEDECOD | Dictionary-Derived Term |
|
text | 200 |
| AEPTCD | Preferred Term Code | integer | 200 | |
| AEHLT | High Level Term | text | 200 | |
| AEHLTCD | High Level Term Code | integer | 200 | |
| AEHLGT | High Level Group Term | text | 200 | |
| AEHLGTCD | High Level Group Term Code | integer | 200 | |
| AECAT | Category for Adverse Event | text | 200 | |
| AESCAT | Subcategory for Adverse Event | text | 200 | |
| AEPRESP | Pre-Specified Adverse Event | text | 200 | |
| AEOCCUR | Occurrence | text | 200 | |
| AESTAT | Completion Status | text | 200 | |
| AEREASND | Reason Not Done | text | 200 | |
| AEBODSYS | Body System or Organ Class | text | 200 | |
| AEBDSYCD | Body System or Organ Class Code | integer | 200 | |
| AESOC | Primary System Organ Class | text | 200 | |
| AESOCCD | Primary System Organ Class Code | integer | 200 | |
| AELOC | Location of Event | text | 200 | |
| AELAT | Laterality | text | 200 | |
| AEDIR | Directionality | text | 200 | |
| AEPORTOT | Portion or Totality | text | 200 | |
| AEPARTY | Accountable Party | text | 200 | |
| AEPRTYID | Identification of Accountable Party | text | 200 | |
| AESEV | Severity/Intensity | text | 200 | |
| AESER | Serious Event | text | 200 | |
| AEACN | Action Taken with Study Treatment | text | 200 | |
| AEACNOTH | Other Action Taken | text | 200 | |
| AEACNDEV | Action Taken with Device | text | 200 | |
| AEREL | Causality | text | 200 | |
| AERELNST | Relationship to Non-Study Treatment | text | 200 | |
| AEPATT | Pattern of Adverse Event | text | 200 | |
| AEOUT | Outcome of Adverse Event | text | 200 | |
| AESCAN | Involves Cancer | text | 200 | |
| AESCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| AESDTH | Results in Death | text | 200 | |
| AESHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| AESLIFE | Is Life Threatening | text | 200 | |
| AESOD | Occurred with Overdose | text | 200 | |
| AESMIE | Other Medically Important Serious Event | text | 200 | |
| AECONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| AETOX | Toxicity | text | 200 | |
| AETOXGR | Standard Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| AEDTC | Date/Time of Collection | datetime | 200 | |
| AESTDTC | Start Date/Time of Adverse Event | datetime | 200 | |
| AEENDTC | End Date/Time of Adverse Event | datetime | 200 | |
| AEDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| AESTDY | Study Day of Start of Adverse Event | integer | 200 | |
| AEENDY | Study Day of End of Adverse Event | integer | 200 | |
| AEDUR | Duration of Adverse Event | text | 200 | |
| AETPT | Planned Time Point Name | text | 200 | |
| AETPTNUM | Planned Time Point Number | float | 200 | |
| AEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| AETPTREF | Time Point Reference | text | 200 | |
| AERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| AESTRF | Start Relative to Reference Period | text | 200 | |
| AEENRF | End Relative to Reference Period | text | 200 | |
| AEEVLINT | Evaluation Interval | text | 200 | |
| AEEVINTX | Evaluation Interval Text | text | 200 | |
| AESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| AESTTPT | Start Reference Time Point | text | 200 | |
| AEENRTPT | End Relative to Reference Time Point | text | 200 | |
| AEENTPT | End Reference Time Point | text | 200 | |
| AESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| AEENINT | Planned End of Assessment Interval | datetime | 200 | |
| AEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1326 | Related Device Identifier (RDEVID) and Related Subject or Pool Identifier (RSUBJID) should not both be populated for the same record. | Condition | RDEVID is not null when RSUBJID is populated |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1440 | MedDRA coding Preferred Term (--DECOD) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%DECOD within %Domain%TERM |
|
|
| SD1441 | MedDRA coding High Level Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLT within %Domain%TERM |
|
|
| SD1442 | MedDRA coding High Level Group Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLGT within %Domain%TERM |
|
|
| SD1443 | Body System (--BODSYS) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%TERM |
|
|
| SD1444 | MedDRA System Organ Class (--SOC) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%SOC within %Domain%TERM |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Associated Persons Medical History
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| APID | Associated Persons Identifier |
|
text | 200 |
| MHSEQ | Sequence Number |
|
float | 200 |
| RSUBJID | Related Subject | text | 200 | |
| RDEVID | Related Device Identifier | text | 200 | |
| SREL | Subject, Device, or Study Relationship |
|
text | 200 |
| MHGRPID | Group ID | text | 200 | |
| MHREFID | Reference ID | text | 200 | |
| MHSPID | Sponsor-Defined Identifier | text | 200 | |
| MHLNKID | Link ID | text | 200 | |
| MHLNKGRP | Link Group ID | text | 200 | |
| MHTERM | Reported Term for the Medical History |
|
text | 200 |
| MHMODIFY | Modified Reported Term | text | 200 | |
| MHLLT | Lowest Level Term | text | 200 | |
| MHLLTCD | Lowest Level Term Code | integer | 200 | |
| MHDECOD | Dictionary-Derived Term | text | 200 | |
| MHPTCD | Preferred Term Code | integer | 200 | |
| MHHLT | High Level Term | text | 200 | |
| MHHLTCD | High Level Term Code | integer | 200 | |
| MHHLGT | High Level Group Term | text | 200 | |
| MHHLGTCD | High Level Group Term Code | integer | 200 | |
| MHCAT | Category for Medical History | text | 200 | |
| MHSCAT | Subcategory for Medical History | text | 200 | |
| MHPRESP | Medical History Event Pre-Specified | text | 200 | |
| MHOCCUR | Medical History Occurrence | text | 200 | |
| MHSTAT | Completion Status | text | 200 | |
| MHREASND | Reason Not Done | text | 200 | |
| MHBODSYS | Body System or Organ Class | text | 200 | |
| MHBDSYCD | Body System or Organ Class Code | integer | 200 | |
| MHSOC | Primary System Organ Class | text | 200 | |
| MHSOCCD | Primary System Organ Class Code | integer | 200 | |
| MHLOC | Location of Event | text | 200 | |
| MHLAT | Laterality | text | 200 | |
| MHDIR | Directionality | text | 200 | |
| MHPORTOT | Portion or Totality | text | 200 | |
| MHPARTY | Accountable Party | text | 200 | |
| MHPRTYID | Identification of Accountable Party | text | 200 | |
| MHSEV | Severity/Intensity | text | 200 | |
| MHSER | Serious Event | text | 200 | |
| MHACN | Action Taken with Study Treatment | text | 200 | |
| MHACNOTH | Other Action Taken | text | 200 | |
| MHACNDEV | Action Taken with Device | text | 200 | |
| MHREL | Causality | text | 200 | |
| MHRELNST | Relationship to Non-Study Treatment | text | 200 | |
| MHPATT | Pattern of Event | text | 200 | |
| MHOUT | Outcome of Event | text | 200 | |
| MHSCAN | Involves Cancer | text | 200 | |
| MHSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| MHSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| MHSDTH | Results in Death | text | 200 | |
| MHSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| MHSLIFE | Is Life Threatening | text | 200 | |
| MHSOD | Occurred with Overdose | text | 200 | |
| MHSMIE | Other Medically Important Serious Event | text | 200 | |
| MHCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| MHTOX | Toxicity | text | 200 | |
| MHTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MHDTC | Date/Time of History Collection | datetime | 200 | |
| MHSTDTC | Start Date/Time of Medical History Event | datetime | 200 | |
| MHENDTC | End Date/Time of Medical History Event | datetime | 200 | |
| MHDY | Study Day of History Collection | integer | 200 | |
| MHSTDY | Study Day of Start of Observation | integer | 200 | |
| MHENDY | Study Day of End of Observation | integer | 200 | |
| MHDUR | Duration | text | 200 | |
| MHTPT | Planned Time Point Name | text | 200 | |
| MHTPTNUM | Planned Time Point Number | float | 200 | |
| MHELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MHTPTREF | Time Point Reference | text | 200 | |
| MHRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MHSTRF | Start Relative to Reference Period | text | 200 | |
| MHENRF | End Relative to Reference Period | text | 200 | |
| MHEVLINT | Evaluation Interval | text | 200 | |
| MHEVINTX | Evaluation Interval Text | text | 200 | |
| MHSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MHSTTPT | Start Reference Time Point | text | 200 | |
| MHENRTPT | End Relative to Reference Time Point | text | 200 | |
| MHENTPT | End Reference Time Point | text | 200 | |
| MHSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MHENINT | Planned End of Assessment Interval | datetime | 200 | |
| MHDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1326 | Related Device Identifier (RDEVID) and Related Subject or Pool Identifier (RSUBJID) should not both be populated for the same record. | Condition | RDEVID is not null when RSUBJID is populated |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1440 | MedDRA coding Preferred Term (--DECOD) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%DECOD within %Domain%TERM |
|
|
| SD1441 | MedDRA coding High Level Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLT within %Domain%TERM |
|
|
| SD1442 | MedDRA coding High Level Group Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLGT within %Domain%TERM |
|
|
| SD1443 | Body System (--BODSYS) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%TERM |
|
|
| SD1444 | MedDRA System Organ Class (--SOC) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%SOC within %Domain%TERM |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Clinical Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| CESEQ | Sequence Number |
|
float | 200 |
| CEGRPID | Group ID | text | 200 | |
| CEREFID | Reference ID | text | 200 | |
| CESPID | Sponsor-Defined Identifier | text | 200 | |
| CELNKID | Link ID | text | 200 | |
| CELNKGRP | Link Group ID | text | 200 | |
| CETERM | Reported Term for the Clinical Event |
|
text | 200 |
| CEMODIFY | Modified Reported Term | text | 200 | |
| CELLT | Lowest Level Term | text | 200 | |
| CELLTCD | Lowest Level Term Code | integer | 200 | |
| CEDECOD | Dictionary-Derived Term | text | 200 | |
| CEPTCD | Preferred Term Code | integer | 200 | |
| CEHLT | High Level Term | text | 200 | |
| CEHLTCD | High Level Term Code | integer | 200 | |
| CEHLGT | High Level Group Term | text | 200 | |
| CEHLGTCD | High Level Group Term Code | integer | 200 | |
| CECAT | Category for Clinical Event | text | 200 | |
| CESCAT | Subcategory for Clinical Event | text | 200 | |
| CEPRESP | Clinical Event Pre-Specified | text | 200 | |
| CEOCCUR | Clinical Event Occurrence | text | 200 | |
| CESTAT | Completion Status | text | 200 | |
| CEREASND | Reason Clinical Event Not Collected | text | 200 | |
| CEBODSYS | Body System or Organ Class | text | 200 | |
| CEBDSYCD | Body System or Organ Class Code | integer | 200 | |
| CESOC | Primary System Organ Class | text | 200 | |
| CESOCCD | Primary System Organ Class Code | integer | 200 | |
| CELOC | Location of Event | text | 200 | |
| CELAT | Laterality | text | 200 | |
| CEDIR | Directionality | text | 200 | |
| CEPORTOT | Portion or Totality | text | 200 | |
| CEPARTY | Accountable Party | text | 200 | |
| CEPRTYID | Identification of Accountable Party | text | 200 | |
| CESEV | Severity/Intensity | text | 200 | |
| CESER | Serious Event | text | 200 | |
| CEACN | Action Taken with Study Treatment | text | 200 | |
| CEACNOTH | Other Action Taken | text | 200 | |
| CEACNDEV | Action Taken with Device | text | 200 | |
| CEREL | Causality | text | 200 | |
| CERELNST | Relationship to Non-Study Treatment | text | 200 | |
| CEPATT | Pattern of Event | text | 200 | |
| CEOUT | Outcome of Event | text | 200 | |
| CESCAN | Involves Cancer | text | 200 | |
| CESCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| CESDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| CESDTH | Results in Death | text | 200 | |
| CESHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| CESLIFE | Is Life Threatening | text | 200 | |
| CESOD | Occurred with Overdose | text | 200 | |
| CESMIE | Other Medically Important Serious Event | text | 200 | |
| CECONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| CETOX | Toxicity | text | 200 | |
| CETOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| CEDTC | Date/Time of Event Collection | datetime | 200 | |
| CESTDTC | Start Date/Time of Clinical Event | datetime | 200 | |
| CEENDTC | End Date/Time of Clinical Event | datetime | 200 | |
| CEDY | Study Day of Event Collection | integer | 200 | |
| CESTDY | Study Day of Start of Observation | integer | 200 | |
| CEENDY | Study Day of End of Observation | integer | 200 | |
| CEDUR | Duration | text | 200 | |
| CETPT | Planned Time Point Name | text | 200 | |
| CETPTNUM | Planned Time Point Number | float | 200 | |
| CEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| CETPTREF | Time Point Reference | text | 200 | |
| CERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| CESTRF | Start Relative to Reference Period | text | 200 | |
| CEENRF | End Relative to Reference Period | text | 200 | |
| CEEVLINT | Evaluation Interval | text | 200 | |
| CEEVINTX | Evaluation Interval Text | text | 200 | |
| CESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| CESTTPT | Start Reference Time Point | text | 200 | |
| CEENRTPT | End Relative to Reference Time Point | text | 200 | |
| CEENTPT | End Reference Time Point | text | 200 | |
| CESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| CEENINT | Planned End of Assessment Interval | datetime | 200 | |
| CEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0008 | Value for the Dictionary-Derived Term (--DECOD) variable must be populated using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%DECOD not found in MedDRA dictionary |
|
|
| SD0008C | Case for the Dictionary-Derived Term (--DECOD) variable must be sentence case using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%DECOD is in incorrect case |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
|
|
| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1114 | Value for Body System or Organ Class (--BODSYS) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%BODSYS not found in MedDRA dictionary |
|
|
| SD1114C | Case for Body System or Organ Class (--BODSYS) variable must follow MedDRA sentence case and be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%BODSYS is in incorrect case |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1241 | Body System or Organ Class (--BODSYS) must be populated when Body System or Organ Class Code (--BDSYCD) is populated. | Condition | %Domain%BODSYS is not populated when %Domain%BDSYCD is populated |
|
|
| SD1242 | All values of Body System or Organ Class (--BODSYS) should be the same for a given value of Body System or Organ Class Code (--BDSYCD). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%BDSYCD |
|
|
| SD1243 | All values of Body System or Organ Class Code (--BDSYCD) should be the same for a given value of Body System or Organ Class (--BODSYS). | Unique | Inconsistent value for %Domain%BDSYCD within %Domain%BODSYS |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1440 | MedDRA coding Preferred Term (--DECOD) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%DECOD within %Domain%TERM |
|
|
| SD1441 | MedDRA coding High Level Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLT within %Domain%TERM |
|
|
| SD1442 | MedDRA coding High Level Group Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLGT within %Domain%TERM |
|
|
| SD1443 | Body System (--BODSYS) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%TERM |
|
|
| SD1444 | MedDRA System Organ Class (--SOC) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%SOC within %Domain%TERM |
|
|
| SD2007 | Value for Preferred Term Code (--PTCD) variable must be populated using a Preferred Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%PTCD not found in MedDRA dictionary |
|
|
| SD2008 | Value for Lowest Level Term (--LLT) variable must be populated using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%LLT not found in MedDRA dictionary |
|
|
| SD2008C | Case for Lowest Level Term (--LLT) variable must be sentence case using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%LLT is in incorrect case |
|
|
| SD2009 | Value for Lowest Level Term Code (--LLTCD) variable must be populated using a Lowest Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%LLTCD not found in MedDRA dictionary |
|
|
| SD2010 | Value for High Level Term (--HLT) variable must be populated using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLT not found in MedDRA dictionary |
|
|
| SD2010C | Case for High Level Term (--HLT) variable must be sentence case using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLT is in incorrect case |
|
|
| SD2011 | Value for High Level Term Code (--HLTCD) variable must be populated using a High Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLTCD not found in MedDRA dictionary |
|
|
| SD2012 | Value for High Level Group Term (--HLGT) variable must be populated using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLGT not found in MedDRA dictionary |
|
|
| SD2012C | Case for High Level Group Term (--HLGT) variable must be sentence case using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLGT is in incorrect case |
|
|
| SD2013 | Value for High Level Group Term Code (--HLGTCD) variable must be populated using a High Level Group Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLGTCD not found in MedDRA dictionary |
|
|
| SD2014 | Value for Body System or Organ Class Code (--BDSYCD) variable should be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%BDSYCD not found in MedDRA dictionary |
|
|
| SD2015 | Value for System Organ Class (--SOC) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%SOC not found in MedDRA dictionary |
|
|
| SD2015C | Case for System Organ Class (--SOC) variable must be sentence case using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%SOC is in incorrect case |
|
|
| SD2016 | Value for System Organ Class Code (--SOCCD) variable must be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%SOCCD not found in MedDRA dictionary |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Device Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| DESEQ | Device Events Sequence Number |
|
float | 200 |
| DEGRPID | Group ID | text | 200 | |
| DEREFID | Reference ID | text | 200 | |
| DESPID | Sponsor-Defined Identifier | text | 200 | |
| DELNKID | Link ID | text | 200 | |
| DELNKGRP | Link Group ID | text | 200 | |
| DETERM | Reported Term for Device Event |
|
text | 200 |
| DEMODIFY | Modified Device Event Name | text | 200 | |
| DELLT | Lowest Level Term | text | 200 | |
| DELLTCD | Lowest Level Term Code | integer | 200 | |
| DEDECOD | Device Events Dictionary-Derived Term |
|
text | 200 |
| DEPTCD | Preferred Term Code | integer | 200 | |
| DEHLT | High Level Term | text | 200 | |
| DEHLTCD | High Level Term Code | integer | 200 | |
| DEHLGT | High Level Group Term | text | 200 | |
| DEHLGTCD | High Level Group Term Code | integer | 200 | |
| DECAT | Category of Device Event | text | 200 | |
| DESCAT | Subcategory of Device Event | text | 200 | |
| DEPRESP | Pre-Specified Device Event | text | 200 | |
| DEOCCUR | Device Event Occurrence | text | 200 | |
| DESTAT | Device Event Collection Status | text | 200 | |
| DEREASND | Reason Device Event Not Collected | text | 200 | |
| DEBODSYS | Body System or Organ Class | text | 200 | |
| DEBDSYCD | Body System or Organ Class Code | integer | 200 | |
| DESOC | Primary System Organ Class | text | 200 | |
| DESOCCD | Primary System Organ Class Code | integer | 200 | |
| DELOC | Location of Event | text | 200 | |
| DELAT | Laterality | text | 200 | |
| DEDIR | Directionality | text | 200 | |
| DEPORTOT | Portion or Totality | text | 200 | |
| DEPARTY | Accountable Party | text | 200 | |
| DEPRTYID | Identification of Accountable Party | text | 200 | |
| DESEV | Device Event Severity | text | 200 | |
| DESER | Serious Event | text | 200 | |
| DEACN | Action Taken with Study Treatment | text | 200 | |
| DEACNOTH | Other Action Taken | text | 200 | |
| DEACNDEV | Action Taken with Device | text | 200 | |
| DEREL | Causality | text | 200 | |
| DERELNST | Relationship to Non-Study Treatment | text | 200 | |
| DEPATT | Pattern of Event | text | 200 | |
| DEOUT | Outcome of Event | text | 200 | |
| DESCAN | Involves Cancer | text | 200 | |
| DESCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| DESDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| DESDTH | Results in Death | text | 200 | |
| DESHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| DESLIFE | Is Life Threatening | text | 200 | |
| DESOD | Occurred with Overdose | text | 200 | |
| DESMIE | Other Medically Important Serious Event | text | 200 | |
| DECONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| DETOX | Toxicity | text | 200 | |
| DETOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DEDTC | Date of Device Event Data Collection | datetime | 200 | |
| DESTDTC | Start Date/Time of Device Event | datetime | 200 | |
| DEENDTC | End Date/Time of Device Event | datetime | 200 | |
| DEDY | Study Day of DE Data Collection | integer | 200 | |
| DESTDY | Study Day of DE Start Date/Time | integer | 200 | |
| DEENDY | Study Day of Device Event End Date/Time | integer | 200 | |
| DEDUR | Duration | text | 200 | |
| DETPT | Planned Time Point Name | text | 200 | |
| DETPTNUM | Planned Time Point Number | float | 200 | |
| DEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DETPTREF | Time Point Reference | text | 200 | |
| DERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DESTRF | Start Relative to Reference Period | text | 200 | |
| DEENRF | End Relative to Reference Period | text | 200 | |
| DEEVLINT | Evaluation Interval | text | 200 | |
| DEEVINTX | Evaluation Interval Text | text | 200 | |
| DESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DESTTPT | Start Reference Time Point | text | 200 | |
| DEENRTPT | End Relative to Reference Time Point | text | 200 | |
| DEENTPT | End Reference Time Point | text | 200 | |
| DESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DEENINT | Planned End of Assessment Interval | datetime | 200 | |
| DEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1236 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each combination of Sponsor Device Identifier (SPDEVID) and Unique Subject Identifier (USUBJID) variables' values. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Disposition
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| DSSEQ | Sequence Number |
|
float | 200 |
| DSGRPID | Group ID | text | 200 | |
| DSREFID | Reference ID | text | 200 | |
| DSSPID | Sponsor-Defined Identifier | text | 200 | |
| DSLNKID | Link ID | text | 200 | |
| DSLNKGRP | Link Group ID | text | 200 | |
| DSTERM | Reported Term for the Disposition Event |
|
text | 200 |
| DSMODIFY | Modified Reported Term | text | 200 | |
| DSLLT | Lowest Level Term | text | 200 | |
| DSLLTCD | Lowest Level Term Code | integer | 200 | |
| DSDECOD | Standardized Disposition Term |
|
text | 200 |
| DSPTCD | Preferred Term Code | integer | 200 | |
| DSHLT | High Level Term | text | 200 | |
| DSHLTCD | High Level Term Code | integer | 200 | |
| DSHLGT | High Level Group Term | text | 200 | |
| DSHLGTCD | High Level Group Term Code | integer | 200 | |
| DSCAT | Category for Disposition Event | text | 200 | |
| DSSCAT | Subcategory for Disposition Event | text | 200 | |
| DSPRESP | Pre-specified | text | 200 | |
| DSOCCUR | Occurrence | text | 200 | |
| DSSTAT | Completion Status | text | 200 | |
| DSREASND | Reason Not Done | text | 200 | |
| DSBODSYS | Body System or Organ Class | text | 200 | |
| DSBDSYCD | Body System or Organ Class Code | integer | 200 | |
| DSSOC | Primary System Organ Class | text | 200 | |
| DSSOCCD | Primary System Organ Class Code | integer | 200 | |
| DSLOC | Location of Event | text | 200 | |
| DSLAT | Laterality | text | 200 | |
| DSDIR | Directionality | text | 200 | |
| DSPORTOT | Portion or Totality | text | 200 | |
| DSPARTY | Accountable Party | text | 200 | |
| DSPRTYID | Identification of Accountable Party | text | 200 | |
| DSSEV | Severity/Intensity | text | 200 | |
| DSSER | Serious Event | text | 200 | |
| DSACN | Action Taken with Study Treatment | text | 200 | |
| DSACNOTH | Other Action Taken | text | 200 | |
| DSACNDEV | Action Taken with Device | text | 200 | |
| DSREL | Causality | text | 200 | |
| DSRELNST | Relationship to Non-Study Treatment | text | 200 | |
| DSPATT | Pattern of Event | text | 200 | |
| DSOUT | Outcome of Event | text | 200 | |
| DSSCAN | Involves Cancer | text | 200 | |
| DSSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| DSSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| DSSDTH | Results in Death | text | 200 | |
| DSSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| DSSLIFE | Is Life Threatening | text | 200 | |
| DSSOD | Occurred with Overdose | text | 200 | |
| DSSMIE | Other Medically Important Serious Event | text | 200 | |
| DSCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| DSTOX | Toxicity | text | 200 | |
| DSTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DSDTC | Date/Time of Collection | datetime | 200 | |
| DSSTDTC | Start Date/Time of Disposition Event | datetime | 200 | |
| DSENDTC | End Date/Time of Observation | datetime | 200 | |
| DSDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DSSTDY | Study Day of Start of Disposition Event | integer | 200 | |
| DSENDY | Study Day of End of Observation | integer | 200 | |
| DSDUR | Duration | text | 200 | |
| DSTPT | Planned Time Point Name | text | 200 | |
| DSTPTNUM | Planned Time Point Number | float | 200 | |
| DSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DSTPTREF | Time Point Reference | text | 200 | |
| DSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DSSTRF | Start Relative to Reference Period | text | 200 | |
| DSENRF | End Relative to Reference Period | text | 200 | |
| DSEVLINT | Evaluation Interval | text | 200 | |
| DSEVINTX | Evaluation Interval Text | text | 200 | |
| DSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DSSTTPT | Start Reference Time Point | text | 200 | |
| DSENRTPT | End Relative to Reference Time Point | text | 200 | |
| DSENTPT | End Reference Time Point | text | 200 | |
| DSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DSENINT | Planned End of Assessment Interval | datetime | 200 | |
| DSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1035 | Category for Disposition Event (DSCAT) should be populated. | Condition | Missing value for DSCAT |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1105 | Epoch (EPOCH) variable value should not be populated when Category for Disposition Event (DSCAT) variable value equals 'PROTOCOL MILESTONE'. | Condition | EPOCH variable is populated when DSCAT equals 'PROTOCOL MILESTONE' |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1118 | At least one value of three variables Start Date/Time (--STDTC), Collection Date/Time (--DTC) or Start Study Day (--STDY) should be populated. | Condition | Neither %Domain%STDTC, %Domain%DTC nor %Domain%STDY are populated |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1256 | DTHFL must equal 'Y' when there is a record in the Disposition (DS) domain with DSDECOD = 'DEATH'. | Lookup | DTHFL does not equal 'Y' when DS.DSDECOD = 'DEATH' |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1290 | If multiple disposition events are reported for an EPOCH, the sponsor should identify a primary reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS. | Unique | Multiple disposition events for the same EPOCH |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1313 | Epoch (EPOCH) variable should be provided when Category for Disposition Event (DSCAT) equals 'DISPOSITION EVENT'. | Condition | Missing EPOCH value when DSCAT is 'DISPOSITION EVENT' |
|
|
| SD1314 | When Reported Term for the Disposition Event (DSTERM) is 'COMPLETED', Standardized Disposition Term (DSDECOD) should have the same value 'COMPLETED'. | Condition | DSDECOD is not 'COMPLETED' when DSTERM='COMPLETED' |
|
|
| SD1315 | Reported Term for the Disposition Event (DSTERM) and Standardized Disposition Term (DSDECOD) should contain the same value when Category for Disposition Event (DSCAT) is 'PROTOCOL MILESTONE'. | Condition | DSDECOD is not the same as DSTERM when DSCAT='PROTOCOL MILESTONE' |
|
|
| SD1317 | DEATH records (DSDECOD='DEATH') in the Disposition (DS) domain should have Start Date of Event (DSSTDTC) equal to subject's Date/Time of Death (DTHDTC) populated in the Demographics (DM) domain. Subject's Date/Time of Death info should be consistent across all domains. | Condition | DSSTDTC for DEATH record is not the same as DM.DTHDTC |
|
|
| SD1318 | Subjects who have DSDECOD = 'PROTOCOL VIOLATION' or DSDECOD = 'PROTOCOL DEVIATION' records in the Disposition (DS) domain should have supportive records with details in the Protocol Deviations (DV) domain. | Lookup | No records for subject are found in DV domain |
|
|
| SD1319 | All records in the Disposition (DS) and Protocol Deviations (DV) domains should have the Start Date/Time of Event (--STDTC) equal to or after a subject's Date/Time of Informed Consent (RFICDTC) in the Demographics (DM) domain. | Condition | %Domain%STDTC is before RFICDTC |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Device Tracking and Disposition
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| DTSEQ | Sequence Number |
|
float | 200 |
| DTGRPID | Group ID | text | 200 | |
| DTREFID | Reference ID | text | 200 | |
| DTSPID | Sponsor-Defined Identifier | text | 200 | |
| DTLNKID | Link ID | text | 200 | |
| DTLNKGRP | Link Group ID | text | 200 | |
| DTTERM | Reported Term for the Tracking Event |
|
text | 200 |
| DTMODIFY | Modified Reported Term | text | 200 | |
| DTLLT | Lowest Level Term | text | 200 | |
| DTLLTCD | Lowest Level Term Code | integer | 200 | |
| DTDECOD | Dictionary-Derived Term | text | 200 | |
| DTPTCD | Preferred Term Code | integer | 200 | |
| DTHLT | High Level Term | text | 200 | |
| DTHLTCD | High Level Term Code | integer | 200 | |
| DTHLGT | High Level Group Term | text | 200 | |
| DTHLGTCD | High Level Group Term Code | integer | 200 | |
| DTCAT | Category for Device Tracking Event | text | 200 | |
| DTSCAT | Subcategory for Device Tracking Event | text | 200 | |
| DTPRESP | Pre-specified | text | 200 | |
| DTOCCUR | Occurrence | text | 200 | |
| DTSTAT | Completion Status | text | 200 | |
| DTREASND | Reason Not Done | text | 200 | |
| DTBODSYS | Body System or Organ Class | text | 200 | |
| DTBDSYCD | Body System or Organ Class Code | integer | 200 | |
| DTSOC | Primary System Organ Class | text | 200 | |
| DTSOCCD | Primary System Organ Class Code | integer | 200 | |
| DTLOC | Location of Event | text | 200 | |
| DTLAT | Laterality | text | 200 | |
| DTDIR | Directionality | text | 200 | |
| DTPORTOT | Portion or Totality | text | 200 | |
| DTPARTY | Party Responsible for the Device |
|
text | 200 |
| DTPRTYID | Responsible Party Identifier | text | 200 | |
| DTSEV | Severity/Intensity | text | 200 | |
| DTSER | Serious Event | text | 200 | |
| DTACN | Action Taken with Study Treatment | text | 200 | |
| DTACNOTH | Other Action Taken | text | 200 | |
| DTACNDEV | Action Taken with Device | text | 200 | |
| DTREL | Causality | text | 200 | |
| DTRELNST | Relationship to Non-Study Treatment | text | 200 | |
| DTPATT | Pattern of Event | text | 200 | |
| DTOUT | Outcome of Event | text | 200 | |
| DTSCAN | Involves Cancer | text | 200 | |
| DTSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| DTSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| DTSDTH | Results in Death | text | 200 | |
| DTSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| DTSLIFE | Is Life Threatening | text | 200 | |
| DTSOD | Occurred with Overdose | text | 200 | |
| DTSMIE | Other Medically Important Serious Event | text | 200 | |
| DTCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| DTTOX | Toxicity | text | 200 | |
| DTTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DTDTC | Date/Time of DT Event Collection | datetime | 200 | |
| DTSTDTC | Start Date/Time of Device Tracking Event |
|
datetime | 200 |
| DTENDTC | End Date/Time of Observation | datetime | 200 | |
| DTDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DTSTDY | Study Day of Start of Observation | integer | 200 | |
| DTENDY | Study Day of End of Observation | integer | 200 | |
| DTDUR | Duration | text | 200 | |
| DTTPT | Planned Time Point Name | text | 200 | |
| DTTPTNUM | Planned Time Point Number | float | 200 | |
| DTELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DTTPTREF | Time Point Reference | text | 200 | |
| DTRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DTSTRF | Start Relative to Reference Period | text | 200 | |
| DTENRF | End Relative to Reference Period | text | 200 | |
| DTEVLINT | Evaluation Interval | text | 200 | |
| DTEVINTX | Evaluation Interval Text | text | 200 | |
| DTSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DTSTTPT | Start Reference Time Point | text | 200 | |
| DTENRTPT | End Relative to Reference Time Point | text | 200 | |
| DTENTPT | End Reference Time Point | text | 200 | |
| DTSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DTENINT | Planned End of Assessment Interval | datetime | 200 | |
| DTDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1236 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each combination of Sponsor Device Identifier (SPDEVID) and Unique Subject Identifier (USUBJID) variables' values. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Protocol Deviations
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| DVSEQ | Sequence Number |
|
float | 200 |
| DVGRPID | Group ID | text | 200 | |
| DVREFID | Reference ID | text | 200 | |
| DVSPID | Sponsor-Defined Identifier | text | 200 | |
| DVLNKID | Link ID | text | 200 | |
| DVLNKGRP | Link Group ID | text | 200 | |
| DVTERM | Protocol Deviation Term |
|
text | 200 |
| DVMODIFY | Modified Reported Term | text | 200 | |
| DVLLT | Lowest Level Term | text | 200 | |
| DVLLTCD | Lowest Level Term Code | integer | 200 | |
| DVDECOD | Protocol Deviation Coded Term | text | 200 | |
| DVPTCD | Preferred Term Code | integer | 200 | |
| DVHLT | High Level Term | text | 200 | |
| DVHLTCD | High Level Term Code | integer | 200 | |
| DVHLGT | High Level Group Term | text | 200 | |
| DVHLGTCD | High Level Group Term Code | integer | 200 | |
| DVCAT | Category for Protocol Deviation | text | 200 | |
| DVSCAT | Subcategory for Protocol Deviation | text | 200 | |
| DVPRESP | Pre-specified | text | 200 | |
| DVOCCUR | Occurrence | text | 200 | |
| DVSTAT | Completion Status | text | 200 | |
| DVREASND | Reason Not Done | text | 200 | |
| DVBODSYS | Body System or Organ Class | text | 200 | |
| DVBDSYCD | Body System or Organ Class Code | integer | 200 | |
| DVSOC | Primary System Organ Class | text | 200 | |
| DVSOCCD | Primary System Organ Class Code | integer | 200 | |
| DVLOC | Location of Event | text | 200 | |
| DVLAT | Laterality | text | 200 | |
| DVDIR | Directionality | text | 200 | |
| DVPORTOT | Portion or Totality | text | 200 | |
| DVPARTY | Accountable Party | text | 200 | |
| DVPRTYID | Identification of Accountable Party | text | 200 | |
| DVSEV | Severity/Intensity | text | 200 | |
| DVSER | Serious Event | text | 200 | |
| DVACN | Action Taken with Study Treatment | text | 200 | |
| DVACNOTH | Other Action Taken | text | 200 | |
| DVACNDEV | Action Taken with Device | text | 200 | |
| DVREL | Causality | text | 200 | |
| DVRELNST | Relationship to Non-Study Treatment | text | 200 | |
| DVPATT | Pattern of Event | text | 200 | |
| DVOUT | Outcome of Event | text | 200 | |
| DVSCAN | Involves Cancer | text | 200 | |
| DVSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| DVSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| DVSDTH | Results in Death | text | 200 | |
| DVSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| DVSLIFE | Is Life Threatening | text | 200 | |
| DVSOD | Occurred with Overdose | text | 200 | |
| DVSMIE | Other Medically Important Serious Event | text | 200 | |
| DVCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| DVTOX | Toxicity | text | 200 | |
| DVTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DVDTC | Date/Time of Collection | datetime | 200 | |
| DVSTDTC | Start Date/Time of Deviation | datetime | 200 | |
| DVENDTC | End Date/Time of Deviation | datetime | 200 | |
| DVDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DVSTDY | Study Day of Start of Deviation | integer | 200 | |
| DVENDY | Study Day of End of Deviation | integer | 200 | |
| DVDUR | Duration | text | 200 | |
| DVTPT | Planned Time Point Name | text | 200 | |
| DVTPTNUM | Planned Time Point Number | float | 200 | |
| DVELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DVTPTREF | Time Point Reference | text | 200 | |
| DVRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DVSTRF | Start Relative to Reference Period | text | 200 | |
| DVENRF | End Relative to Reference Period | text | 200 | |
| DVEVLINT | Evaluation Interval | text | 200 | |
| DVEVINTX | Evaluation Interval Text | text | 200 | |
| DVSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DVSTTPT | Start Reference Time Point | text | 200 | |
| DVENRTPT | End Relative to Reference Time Point | text | 200 | |
| DVENTPT | End Reference Time Point | text | 200 | |
| DVSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DVENINT | Planned End of Assessment Interval | datetime | 200 | |
| DVDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
|
|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
|
|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
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| SD1319 | All records in the Disposition (DS) and Protocol Deviations (DV) domains should have the Start Date/Time of Event (--STDTC) equal to or after a subject's Date/Time of Informed Consent (RFICDTC) in the Demographics (DM) domain. | Condition | %Domain%STDTC is before RFICDTC |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Healthcare Encounters
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| HOSEQ | Sequence Number |
|
float | 200 |
| HOGRPID | Group ID | text | 200 | |
| HOREFID | Reference ID | text | 200 | |
| HOSPID | Sponsor-Defined Identifier | text | 200 | |
| HOLNKID | Link ID | text | 200 | |
| HOLNKGRP | Link Group ID | text | 200 | |
| HOTERM | Reported Term for Healthcare Encounter |
|
text | 200 |
| HOMODIFY | Modified Reported Term | text | 200 | |
| HOLLT | Lowest Level Term | text | 200 | |
| HOLLTCD | Lowest Level Term Code | integer | 200 | |
| HODECOD | Dictionary-Derived Term | text | 200 | |
| HOPTCD | Preferred Term Code | integer | 200 | |
| HOHLT | High Level Term | text | 200 | |
| HOHLTCD | High Level Term Code | integer | 200 | |
| HOHLGT | High Level Group Term | text | 200 | |
| HOHLGTCD | High Level Group Term Code | integer | 200 | |
| HOCAT | Category for Healthcare Encounter | text | 200 | |
| HOSCAT | Subcategory for Healthcare Encounter | text | 200 | |
| HOPRESP | Pre-Specified Healthcare Encounter | text | 200 | |
| HOOCCUR | Healthcare Encounter Occurrence | text | 200 | |
| HOSTAT | Completion Status | text | 200 | |
| HOREASND | Reason Healthcare Encounter Not Done | text | 200 | |
| HOBODSYS | Body System or Organ Class | text | 200 | |
| HOBDSYCD | Body System or Organ Class Code | integer | 200 | |
| HOSOC | Primary System Organ Class | text | 200 | |
| HOSOCCD | Primary System Organ Class Code | integer | 200 | |
| HOLOC | Location of Event | text | 200 | |
| HOLAT | Laterality | text | 200 | |
| HODIR | Directionality | text | 200 | |
| HOPORTOT | Portion or Totality | text | 200 | |
| HOPARTY | Accountable Party | text | 200 | |
| HOPRTYID | Identification of Accountable Party | text | 200 | |
| HOSEV | Severity/Intensity | text | 200 | |
| HOSER | Serious Event | text | 200 | |
| HOACN | Action Taken with Study Treatment | text | 200 | |
| HOACNOTH | Other Action Taken | text | 200 | |
| HOACNDEV | Action Taken with Device | text | 200 | |
| HOREL | Causality | text | 200 | |
| HORELNST | Relationship to Non-Study Treatment | text | 200 | |
| HOPATT | Pattern of Event | text | 200 | |
| HOOUT | Outcome of Event | text | 200 | |
| HOSCAN | Involves Cancer | text | 200 | |
| HOSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| HOSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| HOSDTH | Results in Death | text | 200 | |
| HOSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| HOSLIFE | Is Life Threatening | text | 200 | |
| HOSOD | Occurred with Overdose | text | 200 | |
| HOSMIE | Other Medically Important Serious Event | text | 200 | |
| HOCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| HOTOX | Toxicity | text | 200 | |
| HOTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| HODTC | Date/Time of Event Collection | datetime | 200 | |
| HOSTDTC | Start Date/Time of Healthcare Encounter | datetime | 200 | |
| HOENDTC | End Date/Time of Healthcare Encounter | datetime | 200 | |
| HODY | Study Day of Event Collection | integer | 200 | |
| HOSTDY | Study Day of Start of Observation | integer | 200 | |
| HOENDY | Study Day of End of Healthcare Encounter | integer | 200 | |
| HODUR | Duration of Healthcare Encounter | text | 200 | |
| HOTPT | Planned Time Point Name | text | 200 | |
| HOTPTNUM | Planned Time Point Number | float | 200 | |
| HOELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| HOTPTREF | Time Point Reference | text | 200 | |
| HORFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| HOSTRF | Start Relative to Reference Period | text | 200 | |
| HOENRF | End Relative to Reference Period | text | 200 | |
| HOEVLINT | Evaluation Interval | text | 200 | |
| HOEVINTX | Evaluation Interval Text | text | 200 | |
| HOSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| HOSTTPT | Start Reference Time Point | text | 200 | |
| HOENRTPT | End Relative to Reference Time Point | text | 200 | |
| HOENTPT | End Reference Time Point | text | 200 | |
| HOSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| HOENINT | Planned End of Assessment Interval | datetime | 200 | |
| HODETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
|
|
| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
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|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
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|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
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|
| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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|
| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
|
|
| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
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|
| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
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| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Medical History
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| MHSEQ | Sequence Number |
|
float | 200 |
| MHGRPID | Group ID | text | 200 | |
| MHREFID | Reference ID | text | 200 | |
| MHSPID | Sponsor-Defined Identifier | text | 200 | |
| MHLNKID | Link ID | text | 200 | |
| MHLNKGRP | Link Group ID | text | 200 | |
| MHTERM | Reported Term for the Medical History |
|
text | 200 |
| MHMODIFY | Modified Reported Term | text | 200 | |
| MHLLT | Lowest Level Term | text | 200 | |
| MHLLTCD | Lowest Level Term Code | integer | 200 | |
| MHDECOD | Dictionary-Derived Term | text | 200 | |
| MHPTCD | Preferred Term Code | integer | 200 | |
| MHHLT | High Level Term | text | 200 | |
| MHHLTCD | High Level Term Code | integer | 200 | |
| MHHLGT | High Level Group Term | text | 200 | |
| MHHLGTCD | High Level Group Term Code | integer | 200 | |
| MHCAT | Category for Medical History | text | 200 | |
| MHSCAT | Subcategory for Medical History | text | 200 | |
| MHPRESP | Medical History Event Pre-Specified | text | 200 | |
| MHOCCUR | Medical History Occurrence | text | 200 | |
| MHSTAT | Completion Status | text | 200 | |
| MHREASND | Reason Not Done | text | 200 | |
| MHBODSYS | Body System or Organ Class | text | 200 | |
| MHBDSYCD | Body System or Organ Class Code | integer | 200 | |
| MHSOC | Primary System Organ Class | text | 200 | |
| MHSOCCD | Primary System Organ Class Code | integer | 200 | |
| MHLOC | Location of Event | text | 200 | |
| MHLAT | Laterality | text | 200 | |
| MHDIR | Directionality | text | 200 | |
| MHPORTOT | Portion or Totality | text | 200 | |
| MHPARTY | Accountable Party | text | 200 | |
| MHPRTYID | Identification of Accountable Party | text | 200 | |
| MHSEV | Severity/Intensity | text | 200 | |
| MHSER | Serious Event | text | 200 | |
| MHACN | Action Taken with Study Treatment | text | 200 | |
| MHACNOTH | Other Action Taken | text | 200 | |
| MHACNDEV | Action Taken with Device | text | 200 | |
| MHREL | Causality | text | 200 | |
| MHRELNST | Relationship to Non-Study Treatment | text | 200 | |
| MHPATT | Pattern of Event | text | 200 | |
| MHOUT | Outcome of Event | text | 200 | |
| MHSCAN | Involves Cancer | text | 200 | |
| MHSCONG | Congenital Anomaly or Birth Defect | text | 200 | |
| MHSDISAB | Persist or Signif Disability/Incapacity | text | 200 | |
| MHSDTH | Results in Death | text | 200 | |
| MHSHOSP | Requires or Prolongs Hospitalization | text | 200 | |
| MHSLIFE | Is Life Threatening | text | 200 | |
| MHSOD | Occurred with Overdose | text | 200 | |
| MHSMIE | Other Medically Important Serious Event | text | 200 | |
| MHCONTRT | Concomitant or Additional Trtmnt Given | text | 200 | |
| MHTOX | Toxicity | text | 200 | |
| MHTOXGR | Toxicity Grade | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MHDTC | Date/Time of History Collection | datetime | 200 | |
| MHSTDTC | Start Date/Time of Medical History Event | datetime | 200 | |
| MHENDTC | End Date/Time of Medical History Event | datetime | 200 | |
| MHDY | Study Day of History Collection | integer | 200 | |
| MHSTDY | Study Day of Start of Observation | integer | 200 | |
| MHENDY | Study Day of End of Observation | integer | 200 | |
| MHDUR | Duration | text | 200 | |
| MHTPT | Planned Time Point Name | text | 200 | |
| MHTPTNUM | Planned Time Point Number | float | 200 | |
| MHELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MHTPTREF | Time Point Reference | text | 200 | |
| MHRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MHSTRF | Start Relative to Reference Period | text | 200 | |
| MHENRF | End Relative to Reference Period | text | 200 | |
| MHEVLINT | Evaluation Interval | text | 200 | |
| MHEVINTX | Evaluation Interval Text | text | 200 | |
| MHSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MHSTTPT | Start Reference Time Point | text | 200 | |
| MHENRTPT | End Relative to Reference Time Point | text | 200 | |
| MHENTPT | End Reference Time Point | text | 200 | |
| MHSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MHENINT | Planned End of Assessment Interval | datetime | 200 | |
| MHDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0008 | Value for the Dictionary-Derived Term (--DECOD) variable must be populated using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%DECOD not found in MedDRA dictionary |
|
|
| SD0008C | Case for the Dictionary-Derived Term (--DECOD) variable must be sentence case using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%DECOD is in incorrect case |
|
|
| SD0012 | Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY). | Condition | %Domain%STDY is after %Domain%ENDY |
|
|
| SD0013 | Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC). | Condition | %Domain%STDTC is after %Domain%ENDTC |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0021 | One End Time-Point variable is expected to be populated when an event or an intervention occurred. (E.g., End Date/Time of Event or Intervention (--ENDTC), or End Relative to Reference Period (--ENRF), or End Relative to Reference Period (--ENRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '') or Duration (--DUR) != ''). | Condition | Missing End Time-Point value |
|
|
| SD0022 | One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != ''). | Condition | Missing Start Time-Point value |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0031 | Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL. | Condition | Missing values for %Domain%STDTC, %Domain%STRF and %Domain%STRTPT when %Domain%ENDTC, %Domain%ENRF or %Domain%ENRTPT is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0041 | Occurrence (--OCCUR) may only be populated when a given Intervention or Event has been pre-specified (--PRESP = 'Y'). | Condition | Value for %Domain%OCCUR is populated for unsolicited Intervention or Event |
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| SD0042 | When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE'. | Condition | %Domain%STAT does not equal 'NOT DONE' when %Domain%PRESP='Y' and %Domain%OCCUR is NULL |
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| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
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| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
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| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
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| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
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| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1042 | Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated when an event or intervention is marked as not occurred (--OCCUR='N'). | Condition | Time point for non-occurred event or intervention is provided |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1096 | SAS v5 export format has a limitation on variables length up to 200 characters. If the collected value was more than 200 characters, then SUPPQUAL dataset should be used to store additional 200+ characters. Variable QNAM should have --TERM1, ---TERM2, etc. values for those records. Value splitting should be performed between words or numbers. See SDTM IG #4.1.5.3.2 for details. This risk-assessment check is triggered based on assumption that if original value was truncated, then the actual data value length is exactly 200 characters. | Lookup | High risk of truncated value for %Domain%TERM variable |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1114 | Value for Body System or Organ Class (--BODSYS) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%BODSYS not found in MedDRA dictionary |
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| SD1114C | Case for Body System or Organ Class (--BODSYS) variable must follow MedDRA sentence case and be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%BODSYS is in incorrect case |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1144 | The medical history dataset includes the subject's prior history at the start of the trial. Start Date/Time of Medical History Event (MHSTDTC) should be before Subject Reference Start Date/Time (RFSTDTC). | Condition | MHSTDTC date is after RFSTDTC |
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| SD1147 | Pre-specified (--PRESP) variable should be included into dataset when Occurrence (--OCCUR) variable is present. (--PRESP/Events) Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events. (--PRESP/Interventions) Used when a specific intervention is pre-specified on a CRF. Values should be 'Y' or null. (--OCCUR) Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited. | Find | Missing %Domain%PRESP variable when %Domain%OCCUR variable is present |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1201 | The structure of Events class domains should be one record per Event per subject. No Events with the same Collected Term (--TERM), Decoded Term (--DECOD), Category (--CAT), Subcategory (--SCAT), Occurrence (--OCCUR), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Severity (--SEV), Toxicity Grade (--TOXGR), Visit Number (VISITNUM), Visit Day (VISITDY), and Start Reference Time Point (--STTPT) values for the same Subject (USUBJID) and the same Start Date (--STDTC) are expected. | Unique | Duplicate records in %Domain% domain |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1241 | Body System or Organ Class (--BODSYS) must be populated when Body System or Organ Class Code (--BDSYCD) is populated. | Condition | %Domain%BODSYS is not populated when %Domain%BDSYCD is populated |
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| SD1242 | All values of Body System or Organ Class (--BODSYS) should be the same for a given value of Body System or Organ Class Code (--BDSYCD). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%BDSYCD |
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| SD1243 | All values of Body System or Organ Class Code (--BDSYCD) should be the same for a given value of Body System or Organ Class (--BODSYS). | Unique | Inconsistent value for %Domain%BDSYCD within %Domain%BODSYS |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1274 | Reported Term variables (--TERM) should not be populated with values of 'OTHER'. | Condition | %Domain%TERM equals 'OTHER' |
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| SD1277 | Reported Term variables (--TERM) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TERM equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1287 | All values of Dictionary-Derived Term (--DECOD) should be the same for a given value of Preferred Term Code (--PTCD). | Unique | Inconsistent value for %Domain%DECOD within %Domain%PTCD |
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| SD1288 | All values of Preferred Term Code (--PTCD) should be the same for a given value of Dictionary-Derived Term (--DECOD). | Unique | Inconsistent value for %Domain%PTCD within %Domain%DECOD |
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| SD1289 | Dictionary-Derived Term (--DECOD) should be populated when Preferred Term Code (--PTCD) is populated. | Required | Missing value for %Domain%DECOD when %Domain%PTCD is populated |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1293 | Reason Not Done (--REASND) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%REASND variable is present when %Domain%PRESP variable is missing |
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| SD1294 | Completion Status (--STAT) variable should not be present in the domain when the Pre-specified (--PRESP) variable is missing. | Find | %Domain%STAT variable is present when %Domain%PRESP variable is missing |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1331 | Start Date/Time of Event, Exposure (--STDTC) must be less or equal to Date/Time of Collection(--DTC). | Condition | %Domain%STDTC is after %Domain%DTC |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1440 | MedDRA coding Preferred Term (--DECOD) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%DECOD within %Domain%TERM |
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| SD1441 | MedDRA coding High Level Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLT within %Domain%TERM |
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| SD1442 | MedDRA coding High Level Group Term (--HLT) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%HLGT within %Domain%TERM |
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| SD1443 | Body System (--BODSYS) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%BODSYS within %Domain%TERM |
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| SD1444 | MedDRA System Organ Class (--SOC) should be consistent for the same collected term (--TERM). | Unique | Inconsistent value for %Domain%SOC within %Domain%TERM |
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| SD2007 | Value for Preferred Term Code (--PTCD) variable must be populated using a Preferred Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%PTCD not found in MedDRA dictionary |
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| SD2008 | Value for Lowest Level Term (--LLT) variable must be populated using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%LLT not found in MedDRA dictionary |
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| SD2008C | Case for Lowest Level Term (--LLT) variable must be sentence case using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%LLT is in incorrect case |
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| SD2009 | Value for Lowest Level Term Code (--LLTCD) variable must be populated using a Lowest Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%LLTCD not found in MedDRA dictionary |
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| SD2010 | Value for High Level Term (--HLT) variable must be populated using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLT not found in MedDRA dictionary |
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| SD2010C | Case for High Level Term (--HLT) variable must be sentence case using a High Level Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLT is in incorrect case |
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| SD2011 | Value for High Level Term Code (--HLTCD) variable must be populated using a High Level Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLTCD not found in MedDRA dictionary |
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| SD2012 | Value for High Level Group Term (--HLGT) variable must be populated using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%HLGT not found in MedDRA dictionary |
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| SD2012C | Case for High Level Group Term (--HLGT) variable must be sentence case using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%HLGT is in incorrect case |
|
|
| SD2013 | Value for High Level Group Term Code (--HLGTCD) variable must be populated using a High Level Group Term Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%HLGTCD not found in MedDRA dictionary |
|
|
| SD2014 | Value for Body System or Organ Class Code (--BDSYCD) variable should be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%BDSYCD not found in MedDRA dictionary |
|
|
| SD2015 | Value for System Organ Class (--SOC) variable must be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-insensitive). | Lookup | Value for %Domain%SOC not found in MedDRA dictionary |
|
|
| SD2015C | Case for System Organ Class (--SOC) variable must be sentence case using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml (Case-sensitive). | Lookup | Value for %Domain%SOC is in incorrect case |
|
|
| SD2016 | Value for System Organ Class Code (--SOCCD) variable must be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml. | Lookup | Value for %Domain%SOCCD not found in MedDRA dictionary |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2238 | Start Reference Time Point (--STTPT) value must be consistent for all records with same Subject (USUBJID) and Start Date/Time (--STDTC) values. | Unique | Inconsistent value for %Domain%STTPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TESTCD | Short Name of Measurement, Test or Exam |
|
text | 200 |
| __TEST | Name of Measurement, Test or Examination |
|
text | 200 |
| __MODIFY | Modified Term | text | 200 | |
| __TSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| __CAT | Category | text | 200 | |
| __SCAT | Subcategory | text | 200 | |
| __POS | Position of Subject During Observation | text | 200 | |
| __BODSYS | Body System or Organ Class | text | 200 | |
| __ORRES | Result or Finding in Original Units | text | 200 | |
| __ORRESU | Original Units | text | 200 | |
| __ORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| __ORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| __STRESC | Result or Finding in Standard Format | text | 200 | |
| __STRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| __STRESU | Standard Units | text | 200 | |
| __STNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| __STNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| __STNRC | Normal Range for Character Results | text | 200 | |
| __NRIND | Normal/Reference Range Indicator | text | 200 | |
| __RESCAT | Result Category | text | 200 | |
| __STAT | Completion Status | text | 200 | |
| __REASND | Reason Not Done | text | 200 | |
| __XFN | External File Path | text | 200 | |
| __NAM | Laboratory/Vendor Name | text | 200 | |
| __LOINC | LOINC Code | text | 200 | |
| __SPEC | Specimen Material Type | text | 200 | |
| __ANTREG | Anatomical Region | text | 200 | |
| __SPCCND | Specimen Condition | text | 200 | |
| __SPCUFL | Specimen Usability for the Test | text | 200 | |
| __LOC | Location Used for the Measurement | text | 200 | |
| __LAT | Laterality | text | 200 | |
| __DIR | Directionality | text | 200 | |
| __PORTOT | Portion or Totality | text | 200 | |
| __METHOD | Method of Test or Examination | text | 200 | |
| __RUNID | Run ID | text | 200 | |
| __ANMETH | Analysis Method | text | 200 | |
| __LEAD | Lead Identified to Collect Measurements | text | 200 | |
| __CSTATE | Consciousness State | text | 200 | |
| __BLFL | Baseline Flag | text | 200 | |
| __FAST | Fasting Status | text | 200 | |
| __DRVFL | Derived Flag | text | 200 | |
| __EVAL | Evaluator | text | 200 | |
| __EVALID | Evaluator Identifier | text | 200 | |
| __ACPTFL | Accepted Record Flag | text | 200 | |
| __TOX | Toxicity | text | 200 | |
| __TOXGR | Toxicity Grade | text | 200 | |
| __SEV | Severity | text | 200 | |
| __DTHREL | Relationship to Death | text | 200 | |
| __LLOQ | Lower Limit of Quantitation | float | 200 | |
| __ULOQ | Upper Limit of Quantitation | float | 200 | |
| __EXCLFL | Exclude from Statistics | text | 200 | |
| __REASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| __DTC | Date/Time of Collection | datetime | 200 | |
| __STDTC | Start Date/Time of Observation | datetime | 200 | |
| __ENDTC | End Date/Time of Observation | datetime | 200 | |
| __DY | Study Day of Visit/Collection/Exam | integer | 200 | |
| __STDY | Study Day of Start of Observation | integer | 200 | |
| __ENDY | Study Day of End of Observation | integer | 200 | |
| __DUR | Duration | text | 200 | |
| __TPT | Planned Time Point Name | text | 200 | |
| __TPTNUM | Planned Time Point Number | float | 200 | |
| __ELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| __TPTREF | Time Point Reference | text | 200 | |
| __RFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| __STRF | Start Relative to Reference Period | text | 200 | |
| __ENRF | End Relative to Reference Period | text | 200 | |
| __EVLINT | Evaluation Interval | text | 200 | |
| __EVINTX | Evaluation Interval Text | text | 200 | |
| __STRTPT | Start Relative to Reference Time Point | text | 200 | |
| __STTPT | Start Reference Time Point | text | 200 | |
| __ENRTPT | End Relative to Reference Time Point | text | 200 | |
| __ENTPT | End Reference Time Point | text | 200 | |
| __STINT | Planned Start of Assessment Interval | datetime | 200 | |
| __ENINT | Planned End of Assessment Interval | datetime | 200 | |
| __DETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
|
|
| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1044 | Baseline Flag (--BLFL) should be present in all custom Findings domains. | Find | No %Domain%BLFL variable in custom Findings domain |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Drug Accountability
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| DASEQ | Sequence Number |
|
float | 200 |
| DAGRPID | Group ID | text | 200 | |
| DAREFID | Reference ID | text | 200 | |
| DASPID | Sponsor-Defined Identifier | text | 200 | |
| DALNKID | Link ID | text | 200 | |
| DALNKGRP | Link Group ID | text | 200 | |
| DATESTCD | Short Name of Accountability Assessment |
|
text | 200 |
| DATEST | Name of Accountability Assessment |
|
text | 200 |
| DAMODIFY | Modified Term | text | 200 | |
| DATSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| DACAT | Category of Assessment | text | 200 | |
| DASCAT | Subcategory of Assessment | text | 200 | |
| DAPOS | Position of Subject During Observation | text | 200 | |
| DABODSYS | Body System or Organ Class | text | 200 | |
| DAORRES | Assessment Result in Original Units | text | 200 | |
| DAORRESU | Original Units | text | 200 | |
| DAORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| DAORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| DASTRESC | Assessment Result in Std Format | text | 200 | |
| DASTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| DASTRESU | Assessment Standard Units | text | 200 | |
| DASTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| DASTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| DASTNRC | Normal Range for Character Results | text | 200 | |
| DANRIND | Normal/Reference Range Indicator | text | 200 | |
| DARESCAT | Result Category | text | 200 | |
| DASTAT | Completion Status | text | 200 | |
| DAREASND | Reason Not Performed | text | 200 | |
| DAXFN | External File Path | text | 200 | |
| DANAM | Laboratory/Vendor Name | text | 200 | |
| DALOINC | LOINC Code | text | 200 | |
| DASPEC | Specimen Material Type | text | 200 | |
| DAANTREG | Anatomical Region | text | 200 | |
| DASPCCND | Specimen Condition | text | 200 | |
| DASPCUFL | Specimen Usability for the Test | text | 200 | |
| DALOC | Location Used for the Measurement | text | 200 | |
| DALAT | Laterality | text | 200 | |
| DADIR | Directionality | text | 200 | |
| DAPORTOT | Portion or Totality | text | 200 | |
| DAMETHOD | Method of Test or Examination | text | 200 | |
| DARUNID | Run ID | text | 200 | |
| DAANMETH | Analysis Method | text | 200 | |
| DALEAD | Lead Identified to Collect Measurements | text | 200 | |
| DACSTATE | Consciousness State | text | 200 | |
| DABLFL | Baseline Flag | text | 200 | |
| DAFAST | Fasting Status | text | 200 | |
| DADRVFL | Derived Flag | text | 200 | |
| DAEVAL | Evaluator | text | 200 | |
| DAEVALID | Evaluator Identifier | text | 200 | |
| DAACPTFL | Accepted Record Flag | text | 200 | |
| DATOX | Toxicity | text | 200 | |
| DATOXGR | Toxicity Grade | text | 200 | |
| DASEV | Severity | text | 200 | |
| DADTHREL | Relationship to Death | text | 200 | |
| DALLOQ | Lower Limit of Quantitation | float | 200 | |
| DAULOQ | Upper Limit of Quantitation | float | 200 | |
| DAEXCLFL | Exclude from Statistics | text | 200 | |
| DAREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DADTC | Date/Time of Accountability Assessment | datetime | 200 | |
| DASTDTC | Start Date/Time of Observation | datetime | 200 | |
| DAENDTC | End Date/Time of Observation | datetime | 200 | |
| DADY | Study Day of Accountability Assessment | integer | 200 | |
| DASTDY | Study Day of Start of Assessment | integer | 200 | |
| DAENDY | Study Day of End of Assessment | integer | 200 | |
| DADUR | Duration | text | 200 | |
| DATPT | Planned Time Point Name | text | 200 | |
| DATPTNUM | Planned Time Point Number | float | 200 | |
| DAELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DATPTREF | Time Point Reference | text | 200 | |
| DARFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DASTRF | Start Relative to Reference Period | text | 200 | |
| DAENRF | End Relative to Reference Period | text | 200 | |
| DAEVLINT | Evaluation Interval | text | 200 | |
| DAEVINTX | Evaluation Interval Text | text | 200 | |
| DASTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DASTTPT | Start Reference Time Point | text | 200 | |
| DAENRTPT | End Relative to Reference Time Point | text | 200 | |
| DAENTPT | End Reference Time Point | text | 200 | |
| DASTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DAENINT | Planned End of Assessment Interval | datetime | 200 | |
| DADETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Death Details
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| DDSEQ | Sequence Number |
|
float | 200 |
| DDGRPID | Group ID | text | 200 | |
| DDREFID | Reference ID | text | 200 | |
| DDSPID | Sponsor-Defined Identifier | text | 200 | |
| DDLNKID | Link ID | text | 200 | |
| DDLNKGRP | Link Group ID | text | 200 | |
| DDTESTCD | Death Detail Assessment Short Name |
|
text | 200 |
| DDTEST | Death Detail Assessment Name |
|
text | 200 |
| DDMODIFY | Modified Term | text | 200 | |
| DDTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| DDCAT | Category | text | 200 | |
| DDSCAT | Subcategory | text | 200 | |
| DDPOS | Position of Subject During Observation | text | 200 | |
| DDBODSYS | Body System or Organ Class | text | 200 | |
| DDORRES | Result or Finding as Collected | text | 200 | |
| DDORRESU | Original Units | text | 200 | |
| DDORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| DDORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| DDSTRESC | Character Result/Finding in Std Format | text | 200 | |
| DDSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| DDSTRESU | Standard Units | text | 200 | |
| DDSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| DDSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| DDSTNRC | Normal Range for Character Results | text | 200 | |
| DDNRIND | Normal/Reference Range Indicator | text | 200 | |
| DDRESCAT | Result Category | text | 200 | |
| DDSTAT | Completion Status | text | 200 | |
| DDREASND | Reason Not Done | text | 200 | |
| DDXFN | External File Path | text | 200 | |
| DDNAM | Laboratory/Vendor Name | text | 200 | |
| DDLOINC | LOINC Code | text | 200 | |
| DDSPEC | Specimen Material Type | text | 200 | |
| DDANTREG | Anatomical Region | text | 200 | |
| DDSPCCND | Specimen Condition | text | 200 | |
| DDSPCUFL | Specimen Usability for the Test | text | 200 | |
| DDLOC | Location Used for the Measurement | text | 200 | |
| DDLAT | Laterality | text | 200 | |
| DDDIR | Directionality | text | 200 | |
| DDPORTOT | Portion or Totality | text | 200 | |
| DDMETHOD | Method of Test or Examination | text | 200 | |
| DDRUNID | Run ID | text | 200 | |
| DDANMETH | Analysis Method | text | 200 | |
| DDLEAD | Lead Identified to Collect Measurements | text | 200 | |
| DDCSTATE | Consciousness State | text | 200 | |
| DDBLFL | Baseline Flag | text | 200 | |
| DDFAST | Fasting Status | text | 200 | |
| DDDRVFL | Derived Flag | text | 200 | |
| DDEVAL | Evaluator | text | 200 | |
| DDEVALID | Evaluator Identifier | text | 200 | |
| DDACPTFL | Accepted Record Flag | text | 200 | |
| DDTOX | Toxicity | text | 200 | |
| DDTOXGR | Toxicity Grade | text | 200 | |
| DDSEV | Severity | text | 200 | |
| DDDTHREL | Relationship to Death | text | 200 | |
| DDLLOQ | Lower Limit of Quantitation | float | 200 | |
| DDULOQ | Upper Limit of Quantitation | float | 200 | |
| DDEXCLFL | Exclude from Statistics | text | 200 | |
| DDREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DDDTC | Date/Time of Collection | datetime | 200 | |
| DDSTDTC | Start Date/Time of Observation | datetime | 200 | |
| DDENDTC | End Date/Time of Observation | datetime | 200 | |
| DDDY | Study Day of Collection | integer | 200 | |
| DDSTDY | Study Day of Start of Observation | integer | 200 | |
| DDENDY | Study Day of End of Observation | integer | 200 | |
| DDDUR | Duration | text | 200 | |
| DDTPT | Planned Time Point Name | text | 200 | |
| DDTPTNUM | Planned Time Point Number | float | 200 | |
| DDELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DDTPTREF | Time Point Reference | text | 200 | |
| DDRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DDSTRF | Start Relative to Reference Period | text | 200 | |
| DDENRF | End Relative to Reference Period | text | 200 | |
| DDEVLINT | Evaluation Interval | text | 200 | |
| DDEVINTX | Evaluation Interval Text | text | 200 | |
| DDSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DDSTTPT | Start Reference Time Point | text | 200 | |
| DDENRTPT | End Relative to Reference Time Point | text | 200 | |
| DDENTPT | End Reference Time Point | text | 200 | |
| DDSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DDENINT | Planned End of Assessment Interval | datetime | 200 | |
| DDDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1253 | DTHFL must equal 'Y' when there is a record in the Death Details (DD) domain. | Lookup | DTHFL does not equal 'Y' when DD record is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Device Properties
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier |
|
text | 200 |
| DOSEQ | Sequence Number |
|
float | 200 |
| DOGRPID | Group ID | text | 200 | |
| DOREFID | Reference ID | text | 200 | |
| DOSPID | Sponsor-Defined Identifier | text | 200 | |
| DOLNKID | Link ID | text | 200 | |
| DOLNKGRP | Link Group ID | text | 200 | |
| DOTESTCD | Device Property Short Name |
|
text | 200 |
| DOTEST | Device Property Test Name |
|
text | 200 |
| DOMODIFY | Modified Term | text | 200 | |
| DOTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| DOCAT | Category for Device In-Use | text | 200 | |
| DOSCAT | Subcategory for Device In-Use | text | 200 | |
| DOPOS | Position of Subject During Observation | text | 200 | |
| DOBODSYS | Body System or Organ Class | text | 200 | |
| DOORRES | Result or Finding in Original Units | text | 200 | |
| DOORRESU | Original Units | text | 200 | |
| DOORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| DOORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| DOSTRESC | Result or Finding in Standard Format | text | 200 | |
| DOSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| DOSTRESU | Standard Units | text | 200 | |
| DOSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| DOSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| DOSTNRC | Normal Range for Character Results | text | 200 | |
| DONRIND | Normal/Reference Range Indicator | text | 200 | |
| DORESCAT | Result Category | text | 200 | |
| DOSTAT | Completion Status | text | 200 | |
| DOREASND | Reason Not Done | text | 200 | |
| DOXFN | External File Path | text | 200 | |
| DONAM | Laboratory/Vendor Name | text | 200 | |
| DOLOINC | LOINC Code | text | 200 | |
| DOSPEC | Specimen Material Type | text | 200 | |
| DOANTREG | Anatomical Region | text | 200 | |
| DOSPCCND | Specimen Condition | text | 200 | |
| DOSPCUFL | Specimen Usability for the Test | text | 200 | |
| DOLOC | Location Used for the Measurement | text | 200 | |
| DOLAT | Laterality | text | 200 | |
| DODIR | Directionality | text | 200 | |
| DOPORTOT | Portion or Totality | text | 200 | |
| DOMETHOD | Method of Test or Examination | text | 200 | |
| DORUNID | Run ID | text | 200 | |
| DOANMETH | Analysis Method | text | 200 | |
| DOLEAD | Lead Identified to Collect Measurements | text | 200 | |
| DOCSTATE | Consciousness State | text | 200 | |
| DOBLFL | Baseline Flag | text | 200 | |
| DOFAST | Fasting Status | text | 200 | |
| DODRVFL | Derived Flag | text | 200 | |
| DOEVAL | Evaluator | text | 200 | |
| DOEVALID | Evaluator Identifier | text | 200 | |
| DOACPTFL | Accepted Record Flag | text | 200 | |
| DOTOX | Toxicity | text | 200 | |
| DOTOXGR | Toxicity Grade | text | 200 | |
| DOSEV | Severity | text | 200 | |
| DODTHREL | Relationship to Death | text | 200 | |
| DOLLOQ | Lower Limit of Quantitation | float | 200 | |
| DOULOQ | Upper Limit of Quantitation | float | 200 | |
| DOEXCLFL | Exclude from Statistics | text | 200 | |
| DOREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DODTC | Date/Time of Collection | datetime | 200 | |
| DOSTDTC | Start Date/Time of Observation | datetime | 200 | |
| DOENDTC | End Date/Time of Observation | datetime | 200 | |
| DODY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DOSTDY | Study Day of Start of Observation | integer | 200 | |
| DOENDY | Study Day of End of Observation | integer | 200 | |
| DODUR | Duration | text | 200 | |
| DOTPT | Planned Time Point Name | text | 200 | |
| DOTPTNUM | Planned Time Point Number | float | 200 | |
| DOELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DOTPTREF | Time Point Reference | text | 200 | |
| DORFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DOSTRF | Start Relative to Reference Period | text | 200 | |
| DOENRF | End Relative to Reference Period | text | 200 | |
| DOEVLINT | Evaluation Interval | text | 200 | |
| DOEVINTX | Evaluation Interval Text | text | 200 | |
| DOSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DOSTTPT | Start Reference Time Point | text | 200 | |
| DOENRTPT | End Relative to Reference Time Point | text | 200 | |
| DOENTPT | End Reference Time Point | text | 200 | |
| DOSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DOENINT | Planned End of Assessment Interval | datetime | 200 | |
| DODETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1236 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each combination of Sponsor Device Identifier (SPDEVID) and Unique Subject Identifier (USUBJID) variables' values. | Unique | Duplicate value for %Domain%SEQ variable |
|
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| SD1237 | There should be one record per device property defined by SPDEVID and DOTESTCD variables. | Unique | Duplicate records in Device Property |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Device In-Use
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| DUSEQ | Sequence Number |
|
float | 200 |
| DUGRPID | Group ID | text | 200 | |
| DUREFID | Reference ID | text | 200 | |
| DUSPID | Sponsor-Defined Identifier | text | 200 | |
| DULNKID | Link ID | text | 200 | |
| DULNKGRP | Link Group ID | text | 200 | |
| DUTESTCD | Device In-Use Test Short Name |
|
text | 200 |
| DUTEST | Device In-Use Test Name |
|
text | 200 |
| DUMODIFY | Modified Term | text | 200 | |
| DUTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| DUCAT | Category for Device In-Use | text | 200 | |
| DUSCAT | Subcategory for Device In-Use | text | 200 | |
| DUPOS | Position of Subject During Observation | text | 200 | |
| DUBODSYS | Body System or Organ Class | text | 200 | |
| DUORRES | Result or Finding in Original Units | text | 200 | |
| DUORRESU | Original Units | text | 200 | |
| DUORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| DUORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| DUSTRESC | Character Result/Finding in Std Format | text | 200 | |
| DUSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| DUSTRESU | Standard Units | text | 200 | |
| DUSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| DUSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| DUSTNRC | Normal Range for Character Results | text | 200 | |
| DUNRIND | Normal/Reference Range Indicator | text | 200 | |
| DURESCAT | Result Category | text | 200 | |
| DUSTAT | Completion Status | text | 200 | |
| DUREASND | Reason Not Done | text | 200 | |
| DUXFN | External File Path | text | 200 | |
| DUNAM | Laboratory/Vendor Name | text | 200 | |
| DULOINC | LOINC Code | text | 200 | |
| DUSPEC | Specimen Material Type | text | 200 | |
| DUANTREG | Anatomical Region | text | 200 | |
| DUSPCCND | Specimen Condition | text | 200 | |
| DUSPCUFL | Specimen Usability for the Test | text | 200 | |
| DULOC | Location Used for the Measurement | text | 200 | |
| DULAT | Laterality | text | 200 | |
| DUDIR | Directionality | text | 200 | |
| DUPORTOT | Portion or Totality | text | 200 | |
| DUMETHOD | Method of Test or Examination | text | 200 | |
| DURUNID | Run ID | text | 200 | |
| DUANMETH | Analysis Method | text | 200 | |
| DULEAD | Lead Identified to Collect Measurements | text | 200 | |
| DUCSTATE | Consciousness State | text | 200 | |
| DUBLFL | Baseline Flag | text | 200 | |
| DUFAST | Fasting Status | text | 200 | |
| DUDRVFL | Derived Flag | text | 200 | |
| DUEVAL | Evaluator | text | 200 | |
| DUEVALID | Evaluator Identifier | text | 200 | |
| DUACPTFL | Accepted Record Flag | text | 200 | |
| DUTOX | Toxicity | text | 200 | |
| DUTOXGR | Toxicity Grade | text | 200 | |
| DUSEV | Severity | text | 200 | |
| DUDTHREL | Relationship to Death | text | 200 | |
| DULLOQ | Lower Limit of Quantitation | float | 200 | |
| DUULOQ | Upper Limit of Quantitation | float | 200 | |
| DUEXCLFL | Exclude from Statistics | text | 200 | |
| DUREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DUDTC | Date/Time Device Used With Test/Setting | datetime | 200 | |
| DUSTDTC | Start Date/Time of Observation | datetime | 200 | |
| DUENDTC | End Date/Time of Observation | datetime | 200 | |
| DUDY | Study Day of Observation | integer | 200 | |
| DUSTDY | Study Day of Start of Observation | integer | 200 | |
| DUENDY | Study Day of End of Observation | integer | 200 | |
| DUDUR | Duration | text | 200 | |
| DUTPT | Planned Time Point Name | text | 200 | |
| DUTPTNUM | Planned Time Point Number | float | 200 | |
| DUELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| DUTPTREF | Time Point Reference | text | 200 | |
| DURFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| DUSTRF | Start Relative to Reference Period | text | 200 | |
| DUENRF | End Relative to Reference Period | text | 200 | |
| DUEVLINT | Evaluation Interval | text | 200 | |
| DUEVINTX | Evaluation Interval Text | text | 200 | |
| DUSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| DUSTTPT | Start Reference Time Point | text | 200 | |
| DUENRTPT | End Relative to Reference Time Point | text | 200 | |
| DUENTPT | End Reference Time Point | text | 200 | |
| DUSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| DUENINT | Planned End of Assessment Interval | datetime | 200 | |
| DUDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
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| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
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|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1235 | Value for Sponsor Device Identifier (SPDEVID) or Unique Subject Identifier (USUBJID) variables should be populated for all records in Device In-Use (DU) domain. | Condition | Neither SPDEVID nor USUBJID values are populated |
|
|
| SD1236 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each combination of Sponsor Device Identifier (SPDEVID) and Unique Subject Identifier (USUBJID) variables' values. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
ECG Test Results
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| EGSEQ | Sequence Number |
|
float | 200 |
| EGGRPID | Group ID | text | 200 | |
| EGREFID | ECG Reference ID | text | 200 | |
| EGSPID | Sponsor-Defined Identifier | text | 200 | |
| EGLNKID | Link ID | text | 200 | |
| EGLNKGRP | Link Group ID | text | 200 | |
| EGTESTCD | ECG Test or Examination Short Name |
|
text | 200 |
| EGTEST | ECG Test or Examination Name |
|
text | 200 |
| EGMODIFY | Modified Term | text | 200 | |
| EGTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| EGCAT | Category for ECG | text | 200 | |
| EGSCAT | Subcategory for ECG | text | 200 | |
| EGPOS | ECG Position of Subject | text | 200 | |
| EGBODSYS | Body System or Organ Class | text | 200 | |
| EGORRES | Result or Finding in Original Units | text | 200 | |
| EGORRESU | Original Units | text | 200 | |
| EGORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| EGORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| EGSTRESC | Character Result/Finding in Std Format | text | 200 | |
| EGSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| EGSTRESU | Standard Units | text | 200 | |
| EGSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| EGSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| EGSTNRC | Normal Range for Character Results | text | 200 | |
| EGNRIND | Normal/Reference Range Indicator | text | 200 | |
| EGRESCAT | Result Category | text | 200 | |
| EGSTAT | Completion Status | text | 200 | |
| EGREASND | Reason ECG Not Performed | text | 200 | |
| EGXFN | ECG External File Path | text | 200 | |
| EGNAM | Vendor Name | text | 200 | |
| EGLOINC | LOINC Code | text | 200 | |
| EGSPEC | Specimen Material Type | text | 200 | |
| EGANTREG | Anatomical Region | text | 200 | |
| EGSPCCND | Specimen Condition | text | 200 | |
| EGSPCUFL | Specimen Usability for the Test | text | 200 | |
| EGLOC | Location Used for the Measurement | text | 200 | |
| EGLAT | Laterality | text | 200 | |
| EGDIR | Directionality | text | 200 | |
| EGPORTOT | Portion or Totality | text | 200 | |
| EGMETHOD | Method of ECG Test | text | 200 | |
| EGRUNID | Run ID | text | 200 | |
| EGANMETH | Analysis Method | text | 200 | |
| EGLEAD | Lead Location Used for Measurement | text | 200 | |
| EGCSTATE | Consciousness State | text | 200 | |
| EGBLFL | Baseline Flag | text | 200 | |
| EGFAST | Fasting Status | text | 200 | |
| EGDRVFL | Derived Flag | text | 200 | |
| EGEVAL | Evaluator | text | 200 | |
| EGEVALID | Evaluator Identifier | text | 200 | |
| EGACPTFL | Accepted Record Flag | text | 200 | |
| EGTOX | Toxicity | text | 200 | |
| EGTOXGR | Toxicity Grade | text | 200 | |
| EGSEV | Severity | text | 200 | |
| EGDTHREL | Relationship to Death | text | 200 | |
| EGLLOQ | Lower Limit of Quantitation | float | 200 | |
| EGULOQ | Upper Limit of Quantitation | float | 200 | |
| EGEXCLFL | Exclude from Statistics | text | 200 | |
| EGREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| EGDTC | Date/Time of ECG | datetime | 200 | |
| EGSTDTC | Start Date/Time of Observation | datetime | 200 | |
| EGENDTC | End Date/Time of Observation | datetime | 200 | |
| EGDY | Study Day of ECG | integer | 200 | |
| EGSTDY | Study Day of Start of Observation | integer | 200 | |
| EGENDY | Study Day of End of Observation | integer | 200 | |
| EGDUR | Duration | text | 200 | |
| EGTPT | Planned Time Point Name | text | 200 | |
| EGTPTNUM | Planned Time Point Number | float | 200 | |
| EGELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| EGTPTREF | Time Point Reference | text | 200 | |
| EGRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| EGSTRF | Start Relative to Reference Period | text | 200 | |
| EGENRF | End Relative to Reference Period | text | 200 | |
| EGEVLINT | Evaluation Interval | text | 200 | |
| EGEVINTX | Evaluation Interval Text | text | 200 | |
| EGSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| EGSTTPT | Start Reference Time Point | text | 200 | |
| EGENRTPT | End Relative to Reference Time Point | text | 200 | |
| EGENTPT | End Reference Time Point | text | 200 | |
| EGSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| EGENINT | Planned End of Assessment Interval | datetime | 200 | |
| EGDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
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| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
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| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
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| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
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| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
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| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
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| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
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| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
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| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
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| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
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| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
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| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
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| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
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| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
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| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
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| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
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| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
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| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
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| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
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| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
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| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
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| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
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| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
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| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
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| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
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| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
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| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
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| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
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| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Inclusion/Exclusion Criteria Not Met
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| IESEQ | Sequence Number |
|
float | 200 |
| IEGRPID | Group ID | text | 200 | |
| IEREFID | Reference ID | text | 200 | |
| IESPID | Sponsor-Defined Identifier | text | 200 | |
| IELNKID | Link ID | text | 200 | |
| IELNKGRP | Link Group ID | text | 200 | |
| IETESTCD | Inclusion/Exclusion Criterion Short Name |
|
text | 200 |
| IETEST | Inclusion/Exclusion Criterion |
|
text | 200 |
| IEMODIFY | Modified Term | text | 200 | |
| IETSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| IECAT | Inclusion/Exclusion Category |
|
text | 200 |
| IESCAT | Inclusion/Exclusion Subcategory | text | 200 | |
| IEPOS | Position of Subject During Observation | text | 200 | |
| IEBODSYS | Body System or Organ Class | text | 200 | |
| IEORRES | I/E Criterion Original Result |
|
text | 200 |
| IEORRESU | Original Units | text | 200 | |
| IEORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| IEORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| IESTRESC | I/E Criterion Result in Std Format |
|
text | 200 |
| IESTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| IESTRESU | Standard Units | text | 200 | |
| IESTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| IESTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| IESTNRC | Normal Range for Character Results | text | 200 | |
| IENRIND | Normal/Reference Range Indicator | text | 200 | |
| IERESCAT | Result Category | text | 200 | |
| IESTAT | Completion Status | text | 200 | |
| IEREASND | Reason Not Done | text | 200 | |
| IEXFN | External File Path | text | 200 | |
| IENAM | Laboratory/Vendor Name | text | 200 | |
| IELOINC | LOINC Code | text | 200 | |
| IESPEC | Specimen Material Type | text | 200 | |
| IEANTREG | Anatomical Region | text | 200 | |
| IESPCCND | Specimen Condition | text | 200 | |
| IESPCUFL | Specimen Usability for the Test | text | 200 | |
| IELOC | Location Used for the Measurement | text | 200 | |
| IELAT | Laterality | text | 200 | |
| IEDIR | Directionality | text | 200 | |
| IEPORTOT | Portion or Totality | text | 200 | |
| IEMETHOD | Method of Test or Examination | text | 200 | |
| IERUNID | Run ID | text | 200 | |
| IEANMETH | Analysis Method | text | 200 | |
| IELEAD | Lead Identified to Collect Measurements | text | 200 | |
| IECSTATE | Consciousness State | text | 200 | |
| IEBLFL | Baseline Flag | text | 200 | |
| IEFAST | Fasting Status | text | 200 | |
| IEDRVFL | Derived Flag | text | 200 | |
| IEEVAL | Evaluator | text | 200 | |
| IEEVALID | Evaluator Identifier | text | 200 | |
| IEACPTFL | Accepted Record Flag | text | 200 | |
| IETOX | Toxicity | text | 200 | |
| IETOXGR | Toxicity Grade | text | 200 | |
| IESEV | Severity | text | 200 | |
| IEDTHREL | Relationship to Death | text | 200 | |
| IELLOQ | Lower Limit of Quantitation | float | 200 | |
| IEULOQ | Upper Limit of Quantitation | float | 200 | |
| IEEXCLFL | Exclude from Statistics | text | 200 | |
| IEREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| IEDTC | Date/Time of Collection | datetime | 200 | |
| IESTDTC | Start Date/Time of Observation | datetime | 200 | |
| IEENDTC | End Date/Time of Observation | datetime | 200 | |
| IEDY | Study Day of Collection | integer | 200 | |
| IESTDY | Study Day of Start of Observation | integer | 200 | |
| IEENDY | Study Day of End of Observation | integer | 200 | |
| IEDUR | Duration | text | 200 | |
| IETPT | Planned Time Point Name | text | 200 | |
| IETPTNUM | Planned Time Point Number | float | 200 | |
| IEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| IETPTREF | Time Point Reference | text | 200 | |
| IERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| IESTRF | Start Relative to Reference Period | text | 200 | |
| IEENRF | End Relative to Reference Period | text | 200 | |
| IEEVLINT | Evaluation Interval | text | 200 | |
| IEEVINTX | Evaluation Interval Text | text | 200 | |
| IESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| IESTTPT | Start Reference Time Point | text | 200 | |
| IEENRTPT | End Relative to Reference Time Point | text | 200 | |
| IEENTPT | End Reference Time Point | text | 200 | |
| IESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| IEENINT | Planned End of Assessment Interval | datetime | 200 | |
| IEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD0068 | A value for Inclusion/Exclusion Criterion Short Name (IETESTCD) must be present the Trial Inclusion/Exclusion Criteria (TI) domain. | Lookup | Invalid IETESTCD |
|
|
| SD0085 | I/E Criterion Original Result (IEORRES) and I/E Criterion Result in Std Format (IESTRESC) should have the same value. | Condition | Mismatch between IEORRES and IESTRESC values |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1016 | The combination of Inclusion/Exclusion Criterion Short Name (IETESTCD), Criterion (IETEST), and Category (IECAT) values should match entries in the Trial Inclusion/Exclusion Criteria (TI) dataset. | Lookup | Invalid IETESTCD/IETEST/IECAT |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1045 | I/E Criterion Original Result (IEORRES) must equal 'Y' when Inclusion/Exclusion Category (IECAT) is 'EXCLUSION'. | Condition | Inconsistent values for IEORRES/IECAT |
|
|
| SD1046 | I/E Criterion Original Result (IEORRES) must equal 'N' when Inclusion/Exclusion Category (IECAT) is 'INCLUSION'. | Condition | Inconsistent values for IEORRES/IECAT |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Immunogenicity Specimen Assessments
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| ISSEQ | Sequence Number |
|
float | 200 |
| ISGRPID | Group ID | text | 200 | |
| ISREFID | Reference ID | text | 200 | |
| ISSPID | Sponsor-Defined Identifier | text | 200 | |
| ISLNKID | Link ID | text | 200 | |
| ISLNKGRP | Link Group ID | text | 200 | |
| ISTESTCD | Immunogenicity Test/Exam Short Name |
|
text | 200 |
| ISTEST | Immunogenicity Test or Examination Name |
|
text | 200 |
| ISMODIFY | Modified Term | text | 200 | |
| ISTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| ISCAT | Category for Immunogenicity Test | text | 200 | |
| ISSCAT | Subcategory for Immunogenicity Test | text | 200 | |
| ISPOS | Position of Subject During Observation | text | 200 | |
| ISBODSYS | Body System or Organ Class | text | 200 | |
| ISORRES | Results or Findings in Original Units | text | 200 | |
| ISORRESU | Original Units | text | 200 | |
| ISORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| ISORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| ISSTRESC | Result or Finding in Standard Format | text | 200 | |
| ISSTRESN | Numeric Results/Findings in Std. Units | float | 200 | |
| ISSTRESU | Standard Units | text | 200 | |
| ISSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| ISSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| ISSTNRC | Normal Range for Character Results | text | 200 | |
| ISNRIND | Normal/Reference Range Indicator | text | 200 | |
| ISRESCAT | Result Category | text | 200 | |
| ISSTAT | Completion Status | text | 200 | |
| ISREASND | Reason Not Done | text | 200 | |
| ISXFN | External File Path | text | 200 | |
| ISNAM | Vendor Name | text | 200 | |
| ISLOINC | LOINC Code | text | 200 | |
| ISSPEC | Specimen Type | text | 200 | |
| ISANTREG | Anatomical Region | text | 200 | |
| ISSPCCND | Specimen Condition | text | 200 | |
| ISSPCUFL | Specimen Usability for the Test | text | 200 | |
| ISLOC | Location Used for the Measurement | text | 200 | |
| ISLAT | Laterality | text | 200 | |
| ISDIR | Directionality | text | 200 | |
| ISPORTOT | Portion or Totality | text | 200 | |
| ISMETHOD | Method of Test or Examination | text | 200 | |
| ISRUNID | Run ID | text | 200 | |
| ISANMETH | Analysis Method | text | 200 | |
| ISLEAD | Lead Identified to Collect Measurements | text | 200 | |
| ISCSTATE | Consciousness State | text | 200 | |
| ISBLFL | Baseline Flag | text | 200 | |
| ISFAST | Fasting Status | text | 200 | |
| ISDRVFL | Derived Flag | text | 200 | |
| ISEVAL | Evaluator | text | 200 | |
| ISEVALID | Evaluator Identifier | text | 200 | |
| ISACPTFL | Accepted Record Flag | text | 200 | |
| ISTOX | Toxicity | text | 200 | |
| ISTOXGR | Toxicity Grade | text | 200 | |
| ISSEV | Severity | text | 200 | |
| ISDTHREL | Relationship to Death | text | 200 | |
| ISLLOQ | Lower Limit of Quantitation | float | 200 | |
| ISULOQ | Upper Limit of Quantitation | float | 200 | |
| ISEXCLFL | Exclude from Statistics | text | 200 | |
| ISREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| ISDTC | Date/Time of Collection | datetime | 200 | |
| ISSTDTC | Start Date/Time of Observation | datetime | 200 | |
| ISENDTC | End Date/Time of Observation | datetime | 200 | |
| ISDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| ISSTDY | Study Day of Start of Observation | integer | 200 | |
| ISENDY | Study Day of End of Observation | integer | 200 | |
| ISDUR | Duration | text | 200 | |
| ISTPT | Planned Time Point Name | text | 200 | |
| ISTPTNUM | Planned Time Point Number | float | 200 | |
| ISELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| ISTPTREF | Time Point Reference | text | 200 | |
| ISRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| ISSTRF | Start Relative to Reference Period | text | 200 | |
| ISENRF | End Relative to Reference Period | text | 200 | |
| ISEVLINT | Evaluation Interval | text | 200 | |
| ISEVINTX | Evaluation Interval Text | text | 200 | |
| ISSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| ISSTTPT | Start Reference Time Point | text | 200 | |
| ISENRTPT | End Relative to Reference Time Point | text | 200 | |
| ISENTPT | End Reference Time Point | text | 200 | |
| ISSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| ISENINT | Planned End of Assessment Interval | datetime | 200 | |
| ISDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Laboratory Test Results
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| LBSEQ | Sequence Number |
|
float | 200 |
| LBGRPID | Group ID | text | 200 | |
| LBREFID | Specimen ID | text | 200 | |
| LBSPID | Sponsor-Defined Identifier | text | 200 | |
| LBLNKID | Link ID | text | 200 | |
| LBLNKGRP | Link Group ID | text | 200 | |
| LBTESTCD | Lab Test or Examination Short Name |
|
text | 200 |
| LBTEST | Lab Test or Examination Name |
|
text | 200 |
| LBMODIFY | Modified Term | text | 200 | |
| LBTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| LBCAT | Category for Lab Test | text | 200 | |
| LBSCAT | Subcategory for Lab Test | text | 200 | |
| LBPOS | Position of Subject During Observation | text | 200 | |
| LBBODSYS | Body System or Organ Class | text | 200 | |
| LBORRES | Result or Finding in Original Units | text | 200 | |
| LBORRESU | Original Units | text | 200 | |
| LBORNRLO | Reference Range Lower Limit in Orig Unit | text | 200 | |
| LBORNRHI | Reference Range Upper Limit in Orig Unit | text | 200 | |
| LBSTRESC | Character Result/Finding in Std Format | text | 200 | |
| LBSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| LBSTRESU | Standard Units | text | 200 | |
| LBSTNRLO | Reference Range Lower Limit-Std Units | float | 200 | |
| LBSTNRHI | Reference Range Upper Limit-Std Units | float | 200 | |
| LBSTNRC | Reference Range for Char Rslt-Std Units | text | 200 | |
| LBNRIND | Reference Range Indicator | text | 200 | |
| LBRESCAT | Result Category | text | 200 | |
| LBSTAT | Completion Status | text | 200 | |
| LBREASND | Reason Test Not Done | text | 200 | |
| LBXFN | External File Path | text | 200 | |
| LBNAM | Vendor Name | text | 200 | |
| LBLOINC | LOINC Code | text | 200 | |
| LBSPEC | Specimen Type | text | 200 | |
| LBANTREG | Anatomical Region | text | 200 | |
| LBSPCCND | Specimen Condition | text | 200 | |
| LBSPCUFL | Specimen Usability for the Test | text | 200 | |
| LBLOC | Location Used for the Measurement | text | 200 | |
| LBLAT | Laterality | text | 200 | |
| LBDIR | Directionality | text | 200 | |
| LBPORTOT | Portion or Totality | text | 200 | |
| LBMETHOD | Method of Test or Examination | text | 200 | |
| LBRUNID | Run ID | text | 200 | |
| LBANMETH | Analysis Method | text | 200 | |
| LBLEAD | Lead Identified to Collect Measurements | text | 200 | |
| LBCSTATE | Consciousness State | text | 200 | |
| LBBLFL | Baseline Flag | text | 200 | |
| LBFAST | Fasting Status | text | 200 | |
| LBDRVFL | Derived Flag | text | 200 | |
| LBEVAL | Evaluator | text | 200 | |
| LBEVALID | Evaluator Identifier | text | 200 | |
| LBACPTFL | Accepted Record Flag | text | 200 | |
| LBTOX | Toxicity | text | 200 | |
| LBTOXGR | Standard Toxicity Grade | text | 200 | |
| LBSEV | Severity | text | 200 | |
| LBDTHREL | Relationship to Death | text | 200 | |
| LBLLOQ | Lower Limit of Quantitation | float | 200 | |
| LBULOQ | Upper Limit of Quantitation | float | 200 | |
| LBEXCLFL | Exclude from Statistics | text | 200 | |
| LBREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| LBDTC | Date/Time of Specimen Collection | datetime | 200 | |
| LBSTDTC | Start Date/Time of Specimen Collection | datetime | 200 | |
| LBENDTC | End Date/Time of Specimen Collection | datetime | 200 | |
| LBDY | Study Day of Specimen Collection | integer | 200 | |
| LBSTDY | Study Day of Start of Observation | integer | 200 | |
| LBENDY | Study Day of End of Specimen Collection | integer | 200 | |
| LBDUR | Duration | text | 200 | |
| LBTPT | Planned Time Point Name | text | 200 | |
| LBTPTNUM | Planned Time Point Number | float | 200 | |
| LBELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| LBTPTREF | Time Point Reference | text | 200 | |
| LBRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| LBSTRF | Start Relative to Reference Period | text | 200 | |
| LBENRF | End Relative to Reference Period | text | 200 | |
| LBEVLINT | Evaluation Interval | text | 200 | |
| LBEVINTX | Evaluation Interval Text | text | 200 | |
| LBSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| LBSTTPT | Start Reference Time Point | text | 200 | |
| LBENRTPT | End Relative to Reference Time Point | text | 200 | |
| LBENTPT | End Reference Time Point | text | 200 | |
| LBSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| LBENINT | Planned End of Assessment Interval | datetime | 200 | |
| LBDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
|
|
| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1298 | When a numeric scale is used (Grade 1, Grade 2, etc.), LBTOXGR should only contain the number. | Condition | LBTOXGR is not a numeric value when a numeric scale is used |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
|
| SD2285 | Value for the LOINC Code (--LOINC) variable must be populated using a LOINC coding system version specified in the define.xml. | Lookup | Value for %Domain%LOINC not found in LOINC coding system |
|
Microbiology Specimen
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| MBSEQ | Sequence Number |
|
float | 200 |
| MBGRPID | Group ID | text | 200 | |
| MBREFID | Reference ID | text | 200 | |
| MBSPID | Sponsor-Defined Identifier | text | 200 | |
| MBLNKID | Link ID | text | 200 | |
| MBLNKGRP | Link Group ID | text | 200 | |
| MBTESTCD | Microbiology Test or Finding Short Name |
|
text | 200 |
| MBTEST | Microbiology Test or Finding Name |
|
text | 200 |
| MBMODIFY | Modified Term | text | 200 | |
| MBTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| MBCAT | Category for Microbiology Finding | text | 200 | |
| MBSCAT | Subcategory for Microbiology Finding | text | 200 | |
| MBPOS | Position of Subject During Observation | text | 200 | |
| MBBODSYS | Body System or Organ Class | text | 200 | |
| MBORRES | Result or Finding in Original Units | text | 200 | |
| MBORRESU | Original Units | text | 200 | |
| MBORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| MBORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| MBSTRESC | Character Result/Finding in Std Format | text | 200 | |
| MBSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| MBSTRESU | Standard Units | text | 200 | |
| MBSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| MBSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| MBSTNRC | Normal Range for Character Results | text | 200 | |
| MBNRIND | Normal/Reference Range Indicator | text | 200 | |
| MBRESCAT | Result Category | text | 200 | |
| MBSTAT | Completion Status | text | 200 | |
| MBREASND | Reason Microbiology Not Performed | text | 200 | |
| MBXFN | External File Path | text | 200 | |
| MBNAM | Vendor Name | text | 200 | |
| MBLOINC | LOINC Code | text | 200 | |
| MBSPEC | Specimen Type | text | 200 | |
| MBANTREG | Anatomical Region | text | 200 | |
| MBSPCCND | Specimen Condition | text | 200 | |
| MBSPCUFL | Specimen Usability for the Test | text | 200 | |
| MBLOC | Specimen Collection Location | text | 200 | |
| MBLAT | Laterality | text | 200 | |
| MBDIR | Directionality | text | 200 | |
| MBPORTOT | Portion or Totality | text | 200 | |
| MBMETHOD | Method of Test or Examination | text | 200 | |
| MBRUNID | Run ID | text | 200 | |
| MBANMETH | Analysis Method | text | 200 | |
| MBLEAD | Lead Identified to Collect Measurements | text | 200 | |
| MBCSTATE | Consciousness State | text | 200 | |
| MBBLFL | Baseline Flag | text | 200 | |
| MBFAST | Fasting Status | text | 200 | |
| MBDRVFL | Derived Flag | text | 200 | |
| MBEVAL | Evaluator | text | 200 | |
| MBEVALID | Evaluator Identifier | text | 200 | |
| MBACPTFL | Accepted Record Flag | text | 200 | |
| MBTOX | Toxicity | text | 200 | |
| MBTOXGR | Toxicity Grade | text | 200 | |
| MBSEV | Severity | text | 200 | |
| MBDTHREL | Relationship to Death | text | 200 | |
| MBLLOQ | Lower Limit of Quantitation | float | 200 | |
| MBULOQ | Upper Limit of Quantitation | float | 200 | |
| MBEXCLFL | Exclude from Statistics | text | 200 | |
| MBREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MBDTC | Date/Time of Specimen Collection | datetime | 200 | |
| MBSTDTC | Start Date/Time of Observation | datetime | 200 | |
| MBENDTC | End Date/Time of Observation | datetime | 200 | |
| MBDY | Study Day of MB Specimen Collection | integer | 200 | |
| MBSTDY | Study Day of Start of Observation | integer | 200 | |
| MBENDY | Study Day of End of Observation | integer | 200 | |
| MBDUR | Duration | text | 200 | |
| MBTPT | Planned Time Point Name | text | 200 | |
| MBTPTNUM | Planned Time Point Number | float | 200 | |
| MBELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MBTPTREF | Time Point Reference | text | 200 | |
| MBRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MBSTRF | Start Relative to Reference Period | text | 200 | |
| MBENRF | End Relative to Reference Period | text | 200 | |
| MBEVLINT | Evaluation Interval | text | 200 | |
| MBEVINTX | Evaluation Interval Text | text | 200 | |
| MBSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MBSTTPT | Start Reference Time Point | text | 200 | |
| MBENRTPT | End Relative to Reference Time Point | text | 200 | |
| MBENTPT | End Reference Time Point | text | 200 | |
| MBSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MBENINT | Planned End of Assessment Interval | datetime | 200 | |
| MBDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1263 | MBRESCAT is expected to be populated in all records where a microorganism has been identified (MBTESTCD = 'ORGANISM'), excluding records where MBSTRESC equals 'NO GROWTH' or MBMETHOD equals 'GRAM STAIN'. | Condition | MBRESCAT is null when MBTESTCD = 'ORGANISM' |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
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| SD2285 | Value for the LOINC Code (--LOINC) variable must be populated using a LOINC coding system version specified in the define.xml. | Lookup | Value for %Domain%LOINC not found in LOINC coding system |
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Microscopic Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| MISEQ | Sequence Number |
|
float | 200 |
| MIGRPID | Group ID | text | 200 | |
| MIREFID | Reference ID | text | 200 | |
| MISPID | Sponsor-Defined Identifier | text | 200 | |
| MILNKID | Link ID | text | 200 | |
| MILNKGRP | Link Group ID | text | 200 | |
| MITESTCD | Microscopic Examination Short Name |
|
text | 200 |
| MITEST | Microscopic Examination Name |
|
text | 200 |
| MIMODIFY | Modified Term | text | 200 | |
| MITSTDTL | Microscopic Examination Detail | text | 200 | |
| MICAT | Category for Microscopic Finding | text | 200 | |
| MISCAT | Subcategory for Microscopic Finding | text | 200 | |
| MIPOS | Position of Subject During Observation | text | 200 | |
| MIBODSYS | Body System or Organ Class | text | 200 | |
| MIORRES | Result or Finding in Original Units | text | 200 | |
| MIORRESU | Original Units | text | 200 | |
| MIORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| MIORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| MISTRESC | Result or Finding in Standard Format | text | 200 | |
| MISTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| MISTRESU | Standard Units | text | 200 | |
| MISTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| MISTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| MISTNRC | Normal Range for Character Results | text | 200 | |
| MINRIND | Normal/Reference Range Indicator | text | 200 | |
| MIRESCAT | Result Category | text | 200 | |
| MISTAT | Completion Status | text | 200 | |
| MIREASND | Reason Not Done | text | 200 | |
| MIXFN | External File Path | text | 200 | |
| MINAM | Laboratory/Vendor Name | text | 200 | |
| MILOINC | LOINC Code | text | 200 | |
| MISPEC | Specimen Material Type |
|
text | 200 |
| MIANTREG | Anatomical Region | text | 200 | |
| MISPCCND | Specimen Condition | text | 200 | |
| MISPCUFL | Specimen Usability for the Test | text | 200 | |
| MILOC | Specimen Collection Location | text | 200 | |
| MILAT | Specimen Laterality within Subject | text | 200 | |
| MIDIR | Specimen Directionality within Subject | text | 200 | |
| MIPORTOT | Portion or Totality | text | 200 | |
| MIMETHOD | Method of Test or Examination | text | 200 | |
| MIRUNID | Run ID | text | 200 | |
| MIANMETH | Analysis Method | text | 200 | |
| MILEAD | Lead Identified to Collect Measurements | text | 200 | |
| MICSTATE | Consciousness State | text | 200 | |
| MIBLFL | Baseline Flag | text | 200 | |
| MIFAST | Fasting Status | text | 200 | |
| MIDRVFL | Derived Flag | text | 200 | |
| MIEVAL | Evaluator | text | 200 | |
| MIEVALID | Evaluator Identifier | text | 200 | |
| MIACPTFL | Accepted Record Flag | text | 200 | |
| MITOX | Toxicity | text | 200 | |
| MITOXGR | Toxicity Grade | text | 200 | |
| MISEV | Severity | text | 200 | |
| MIDTHREL | Relationship to Death | text | 200 | |
| MILLOQ | Lower Limit of Quantitation | float | 200 | |
| MIULOQ | Upper Limit of Quantitation | float | 200 | |
| MIEXCLFL | Exclude from Statistics | text | 200 | |
| MIREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MIDTC | Date/Time of Specimen Collection | datetime | 200 | |
| MISTDTC | Start Date/Time of Observation | datetime | 200 | |
| MIENDTC | End Date/Time of Observation | datetime | 200 | |
| MIDY | Study Day of Specimen Collection | integer | 200 | |
| MISTDY | Study Day of Start of Observation | integer | 200 | |
| MIENDY | Study Day of End of Observation | integer | 200 | |
| MIDUR | Duration | text | 200 | |
| MITPT | Planned Time Point Name | text | 200 | |
| MITPTNUM | Planned Time Point Number | float | 200 | |
| MIELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MITPTREF | Time Point Reference | text | 200 | |
| MIRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MISTRF | Start Relative to Reference Period | text | 200 | |
| MIENRF | End Relative to Reference Period | text | 200 | |
| MIEVLINT | Evaluation Interval | text | 200 | |
| MIEVINTX | Evaluation Interval Text | text | 200 | |
| MISTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MISTTPT | Start Reference Time Point | text | 200 | |
| MIENRTPT | End Relative to Reference Time Point | text | 200 | |
| MIENTPT | End Reference Time Point | text | 200 | |
| MISTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MIENINT | Planned End of Assessment Interval | datetime | 200 | |
| MIDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Morphology
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| MOSEQ | Sequence Number |
|
float | 200 |
| MOGRPID | Group ID | text | 200 | |
| MOREFID | Reference ID | text | 200 | |
| MOSPID | Sponsor-Defined Identifier | text | 200 | |
| MOLNKID | Link ID | text | 200 | |
| MOLNKGRP | Link Group ID | text | 200 | |
| MOTESTCD | Test or Examination Short Name |
|
text | 200 |
| MOTEST | Test or Examination Name |
|
text | 200 |
| MOMODIFY | Modified Term | text | 200 | |
| MOTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| MOCAT | Category for Test | text | 200 | |
| MOSCAT | Subcategory for Test | text | 200 | |
| MOPOS | Position of Subject | text | 200 | |
| MOBODSYS | Body System or Organ Class | text | 200 | |
| MOORRES | Result or Finding in Original Units | text | 200 | |
| MOORRESU | Original Units | text | 200 | |
| MOORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| MOORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| MOSTRESC | Character Result/Finding in Std Format | text | 200 | |
| MOSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| MOSTRESU | Standard Units | text | 200 | |
| MOSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| MOSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| MOSTNRC | Normal Range for Character Results | text | 200 | |
| MONRIND | Normal/Reference Range Indicator | text | 200 | |
| MORESCAT | Result Category | text | 200 | |
| MOSTAT | Completion Status | text | 200 | |
| MOREASND | Reason Test Not Performed | text | 200 | |
| MOXFN | External File Path | text | 200 | |
| MONAM | Vendor Name | text | 200 | |
| MOLOINC | LOINC Code | text | 200 | |
| MOSPEC | Specimen Material Type | text | 200 | |
| MOANTREG | Anatomical Region | text | 200 | |
| MOSPCCND | Specimen Condition | text | 200 | |
| MOSPCUFL | Specimen Usability for the Test | text | 200 | |
| MOLOC | Location Used for Measurement | text | 200 | |
| MOLAT | Specimen Laterality within Subject | text | 200 | |
| MODIR | Specimen Directionality within Subject | text | 200 | |
| MOPORTOT | Portion or Totality | text | 200 | |
| MOMETHOD | Method of Procedure Test | text | 200 | |
| MORUNID | Run ID | text | 200 | |
| MOANMETH | Analysis Method | text | 200 | |
| MOLEAD | Lead Identified to Collect Measurements | text | 200 | |
| MOCSTATE | Consciousness State | text | 200 | |
| MOBLFL | Baseline Flag | text | 200 | |
| MOFAST | Fasting Status | text | 200 | |
| MODRVFL | Derived Flag | text | 200 | |
| MOEVAL | Evaluator | text | 200 | |
| MOEVALID | Evaluator Identifier | text | 200 | |
| MOACPTFL | Accepted Record Flag | text | 200 | |
| MOTOX | Toxicity | text | 200 | |
| MOTOXGR | Toxicity Grade | text | 200 | |
| MOSEV | Severity | text | 200 | |
| MODTHREL | Relationship to Death | text | 200 | |
| MOLLOQ | Lower Limit of Quantitation | float | 200 | |
| MOULOQ | Upper Limit of Quantitation | float | 200 | |
| MOEXCLFL | Exclude from Statistics | text | 200 | |
| MOREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MODTC | Date/Time of Test | datetime | 200 | |
| MOSTDTC | Start Date/Time of Observation | datetime | 200 | |
| MOENDTC | End Date/Time of Observation | datetime | 200 | |
| MODY | Study Day of Test | integer | 200 | |
| MOSTDY | Study Day of Start of Observation | integer | 200 | |
| MOENDY | Study Day of End of Observation | integer | 200 | |
| MODUR | Duration | text | 200 | |
| MOTPT | Planned Time Point Name | text | 200 | |
| MOTPTNUM | Planned Time Point Number | float | 200 | |
| MOELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MOTPTREF | Time Point Reference | text | 200 | |
| MORFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MOSTRF | Start Relative to Reference Period | text | 200 | |
| MOENRF | End Relative to Reference Period | text | 200 | |
| MOEVLINT | Evaluation Interval | text | 200 | |
| MOEVINTX | Evaluation Interval Text | text | 200 | |
| MOSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MOSTTPT | Start Reference Time Point | text | 200 | |
| MOENRTPT | End Relative to Reference Time Point | text | 200 | |
| MOENTPT | End Reference Time Point | text | 200 | |
| MOSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MOENINT | Planned End of Assessment Interval | datetime | 200 | |
| MODETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Microbiology Susceptibility
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| MSSEQ | Sequence Number |
|
float | 200 |
| MSGRPID | Group ID |
|
text | 200 |
| MSREFID | Reference ID | text | 200 | |
| MSSPID | Sponsor-Defined Identifier | text | 200 | |
| MSLNKID | Link ID | text | 200 | |
| MSLNKGRP | Link Group ID | text | 200 | |
| MSTESTCD | Microbiology Organism Finding Short Name |
|
text | 200 |
| MSTEST | Organism Test or Finding Name |
|
text | 200 |
| MSMODIFY | Modified Term | text | 200 | |
| MSTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| MSCAT | Category for Organism Findings |
|
text | 200 |
| MSSCAT | Subcategory for Organism Findings | text | 200 | |
| MSPOS | Position of Subject During Observation | text | 200 | |
| MSBODSYS | Body System or Organ Class | text | 200 | |
| MSORRES | Result or Finding in Original Units | text | 200 | |
| MSORRESU | Original Units | text | 200 | |
| MSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| MSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| MSSTRESC | Character Result/Finding in Std Format | text | 200 | |
| MSSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| MSSTRESU | Standard Units | text | 200 | |
| MSSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| MSSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| MSSTNRC | Normal Range for Character Results | text | 200 | |
| MSNRIND | Normal/Reference Range Indicator | text | 200 | |
| MSRESCAT | Result Category | text | 200 | |
| MSSTAT | Completion Status | text | 200 | |
| MSREASND | Reason Test Not Done | text | 200 | |
| MSXFN | External File Path | text | 200 | |
| MSNAM | Vendor Name | text | 200 | |
| MSLOINC | LOINC Code | text | 200 | |
| MSSPEC | Specimen Material Type | text | 200 | |
| MSANTREG | Anatomical Region | text | 200 | |
| MSSPCCND | Specimen Condition | text | 200 | |
| MSSPCUFL | Specimen Usability for the Test | text | 200 | |
| MSLOC | Location Used for the Measurement | text | 200 | |
| MSLAT | Laterality | text | 200 | |
| MSDIR | Directionality | text | 200 | |
| MSPORTOT | Portion or Totality | text | 200 | |
| MSMETHOD | Method of Test or Examination | text | 200 | |
| MSRUNID | Run ID | text | 200 | |
| MSANMETH | Analysis Method | text | 200 | |
| MSLEAD | Lead Identified to Collect Measurements | text | 200 | |
| MSCSTATE | Consciousness State | text | 200 | |
| MSBLFL | Baseline Flag | text | 200 | |
| MSFAST | Fasting Status | text | 200 | |
| MSDRVFL | Derived Flag | text | 200 | |
| MSEVAL | Evaluator | text | 200 | |
| MSEVALID | Evaluator Identifier | text | 200 | |
| MSACPTFL | Accepted Record Flag | text | 200 | |
| MSTOX | Toxicity | text | 200 | |
| MSTOXGR | Toxicity Grade | text | 200 | |
| MSSEV | Severity | text | 200 | |
| MSDTHREL | Relationship to Death | text | 200 | |
| MSLLOQ | Lower Limit of Quantitation | float | 200 | |
| MSULOQ | Upper Limit of Quantitation | float | 200 | |
| MSEXCLFL | Exclude from Statistics | text | 200 | |
| MSREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| MSDTC | Date/Time of Test | datetime | 200 | |
| MSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| MSENDTC | End Date/Time of Observation | datetime | 200 | |
| MSDY | Study Day of Test | integer | 200 | |
| MSSTDY | Study Day of Start of Observation | integer | 200 | |
| MSENDY | Study Day of End of Observation | integer | 200 | |
| MSDUR | Duration | text | 200 | |
| MSTPT | Planned Time Point Name | text | 200 | |
| MSTPTNUM | Planned Time Point Number | float | 200 | |
| MSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MSTPTREF | Time Point Reference | text | 200 | |
| MSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MSSTRF | Start Relative to Reference Period | text | 200 | |
| MSENRF | End Relative to Reference Period | text | 200 | |
| MSEVLINT | Evaluation Interval | text | 200 | |
| MSEVINTX | Evaluation Interval Text | text | 200 | |
| MSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MSSTTPT | Start Reference Time Point | text | 200 | |
| MSENRTPT | End Relative to Reference Time Point | text | 200 | |
| MSENTPT | End Reference Time Point | text | 200 | |
| MSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MSENINT | Planned End of Assessment Interval | datetime | 200 | |
| MSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
|
| SD2285 | Value for the LOINC Code (--LOINC) variable must be populated using a LOINC coding system version specified in the define.xml. | Lookup | Value for %Domain%LOINC not found in LOINC coding system |
|
Pharmacokinetics Concentrations
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| PCSEQ | Sequence Number |
|
float | 200 |
| PCGRPID | Group ID | text | 200 | |
| PCREFID | Reference ID | text | 200 | |
| PCSPID | Sponsor-Defined Identifier | text | 200 | |
| PCLNKID | Link ID | text | 200 | |
| PCLNKGRP | Link Group ID | text | 200 | |
| PCTESTCD | Pharmacokinetic Test Short Name |
|
text | 200 |
| PCTEST | Pharmacokinetic Test Name |
|
text | 200 |
| PCMODIFY | Modified Term | text | 200 | |
| PCTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| PCCAT | Test Category | text | 200 | |
| PCSCAT | Test Subcategory | text | 200 | |
| PCPOS | Position of Subject During Observation | text | 200 | |
| PCBODSYS | Body System or Organ Class | text | 200 | |
| PCORRES | Result or Finding in Original Units | text | 200 | |
| PCORRESU | Original Units | text | 200 | |
| PCORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PCORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PCSTRESC | Result or Finding in Standard Format | text | 200 | |
| PCSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| PCSTRESU | Standard Units | text | 200 | |
| PCSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| PCSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| PCSTNRC | Normal Range for Character Results | text | 200 | |
| PCNRIND | Normal/Reference Range Indicator | text | 200 | |
| PCRESCAT | Result Category | text | 200 | |
| PCSTAT | Completion Status | text | 200 | |
| PCREASND | Reason Test Not Done | text | 200 | |
| PCXFN | External File Path | text | 200 | |
| PCNAM | Vendor Name | text | 200 | |
| PCLOINC | LOINC Code | text | 200 | |
| PCSPEC | Specimen Material Type | text | 200 | |
| PCANTREG | Anatomical Region | text | 200 | |
| PCSPCCND | Specimen Condition | text | 200 | |
| PCSPCUFL | Specimen Usability for the Test | text | 200 | |
| PCLOC | Location Used for the Measurement | text | 200 | |
| PCLAT | Laterality | text | 200 | |
| PCDIR | Directionality | text | 200 | |
| PCPORTOT | Portion or Totality | text | 200 | |
| PCMETHOD | Method of Test or Examination | text | 200 | |
| PCRUNID | Run ID | text | 200 | |
| PCANMETH | Analysis Method | text | 200 | |
| PCLEAD | Lead Identified to Collect Measurements | text | 200 | |
| PCCSTATE | Consciousness State | text | 200 | |
| PCBLFL | Baseline Flag | text | 200 | |
| PCFAST | Fasting Status | text | 200 | |
| PCDRVFL | Derived Flag | text | 200 | |
| PCEVAL | Evaluator | text | 200 | |
| PCEVALID | Evaluator Identifier | text | 200 | |
| PCACPTFL | Accepted Record Flag | text | 200 | |
| PCTOX | Toxicity | text | 200 | |
| PCTOXGR | Toxicity Grade | text | 200 | |
| PCSEV | Severity | text | 200 | |
| PCDTHREL | Relationship to Death | text | 200 | |
| PCLLOQ | Lower Limit of Quantitation | float | 200 | |
| PCULOQ | Upper Limit of Quantitation | float | 200 | |
| PCEXCLFL | Exclude from Statistics | text | 200 | |
| PCREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PCDTC | Date/Time of Specimen Collection | datetime | 200 | |
| PCSTDTC | Start Date/Time of Observation | datetime | 200 | |
| PCENDTC | End Date/Time of Specimen Collection | datetime | 200 | |
| PCDY | Actual Study Day of Specimen Collection | integer | 200 | |
| PCSTDY | Study Day of Start of Observation | integer | 200 | |
| PCENDY | Study Day of End of Observation | integer | 200 | |
| PCDUR | Duration | text | 200 | |
| PCTPT | Planned Time Point Name | text | 200 | |
| PCTPTNUM | Planned Time Point Number | float | 200 | |
| PCELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| PCTPTREF | Time Point Reference | text | 200 | |
| PCRFTDTC | Date/Time of Reference Point | datetime | 200 | |
| PCSTRF | Start Relative to Reference Period | text | 200 | |
| PCENRF | End Relative to Reference Period | text | 200 | |
| PCEVLINT | Evaluation Interval | text | 200 | |
| PCEVINTX | Evaluation Interval Text | text | 200 | |
| PCSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| PCSTTPT | Start Reference Time Point | text | 200 | |
| PCENRTPT | End Relative to Reference Time Point | text | 200 | |
| PCENTPT | End Reference Time Point | text | 200 | |
| PCSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| PCENINT | Planned End of Assessment Interval | datetime | 200 | |
| PCDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
|
|
| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Physical Examination
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| PESEQ | Sequence Number |
|
float | 200 |
| PEGRPID | Group ID | text | 200 | |
| PEREFID | Reference ID | text | 200 | |
| PESPID | Sponsor-Defined Identifier | text | 200 | |
| PELNKID | Link ID | text | 200 | |
| PELNKGRP | Link Group ID | text | 200 | |
| PETESTCD | Body System Examined Short Name |
|
text | 200 |
| PETEST | Body System Examined |
|
text | 200 |
| PEMODIFY | Modified Reported Term | text | 200 | |
| PETSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| PECAT | Category for Examination | text | 200 | |
| PESCAT | Subcategory for Examination | text | 200 | |
| PEPOS | Position of Subject During Observation | text | 200 | |
| PEBODSYS | Body System or Organ Class | text | 200 | |
| PEORRES | Verbatim Examination Finding | text | 200 | |
| PEORRESU | Original Units | text | 200 | |
| PEORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PEORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PESTRESC | Result or Finding in Standard Format | text | 200 | |
| PESTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| PESTRESU | Standard Units | text | 200 | |
| PESTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| PESTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| PESTNRC | Normal Range for Character Results | text | 200 | |
| PENRIND | Normal/Reference Range Indicator | text | 200 | |
| PERESCAT | Result Category | text | 200 | |
| PESTAT | Completion Status | text | 200 | |
| PEREASND | Reason Not Examined | text | 200 | |
| PEXFN | External File Path | text | 200 | |
| PENAM | Laboratory/Vendor Name | text | 200 | |
| PELOINC | LOINC Code | text | 200 | |
| PESPEC | Specimen Material Type | text | 200 | |
| PEANTREG | Anatomical Region | text | 200 | |
| PESPCCND | Specimen Condition | text | 200 | |
| PESPCUFL | Specimen Usability for the Test | text | 200 | |
| PELOC | Location of Physical Exam Finding | text | 200 | |
| PELAT | Laterality | text | 200 | |
| PEDIR | Directionality | text | 200 | |
| PEPORTOT | Portion or Totality | text | 200 | |
| PEMETHOD | Method of Test or Examination | text | 200 | |
| PERUNID | Run ID | text | 200 | |
| PEANMETH | Analysis Method | text | 200 | |
| PELEAD | Lead Identified to Collect Measurements | text | 200 | |
| PECSTATE | Consciousness State | text | 200 | |
| PEBLFL | Baseline Flag | text | 200 | |
| PEFAST | Fasting Status | text | 200 | |
| PEDRVFL | Derived Flag | text | 200 | |
| PEEVAL | Evaluator | text | 200 | |
| PEEVALID | Evaluator Identifier | text | 200 | |
| PEACPTFL | Accepted Record Flag | text | 200 | |
| PETOX | Toxicity | text | 200 | |
| PETOXGR | Toxicity Grade | text | 200 | |
| PESEV | Severity | text | 200 | |
| PEDTHREL | Relationship to Death | text | 200 | |
| PELLOQ | Lower Limit of Quantitation | float | 200 | |
| PEULOQ | Upper Limit of Quantitation | float | 200 | |
| PEEXCLFL | Exclude from Statistics | text | 200 | |
| PEREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PEDTC | Date/Time of Examination | datetime | 200 | |
| PESTDTC | Start Date/Time of Observation | datetime | 200 | |
| PEENDTC | End Date/Time of Observation | datetime | 200 | |
| PEDY | Study Day of Examination | integer | 200 | |
| PESTDY | Study Day of Start of Observation | integer | 200 | |
| PEENDY | Study Day of End of Observation | integer | 200 | |
| PEDUR | Duration | text | 200 | |
| PETPT | Planned Time Point Name | text | 200 | |
| PETPTNUM | Planned Time Point Number | float | 200 | |
| PEELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| PETPTREF | Time Point Reference | text | 200 | |
| PERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| PESTRF | Start Relative to Reference Period | text | 200 | |
| PEENRF | End Relative to Reference Period | text | 200 | |
| PEEVLINT | Evaluation Interval | text | 200 | |
| PEEVINTX | Evaluation Interval Text | text | 200 | |
| PESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| PESTTPT | Start Reference Time Point | text | 200 | |
| PEENRTPT | End Relative to Reference Time Point | text | 200 | |
| PEENTPT | End Reference Time Point | text | 200 | |
| PESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| PEENINT | Planned End of Assessment Interval | datetime | 200 | |
| PEDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Pharmacokinetics Parameters
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| PPSEQ | Sequence Number |
|
float | 200 |
| PPGRPID | Group ID | text | 200 | |
| PPREFID | Reference ID | text | 200 | |
| PPSPID | Sponsor-Defined Identifier | text | 200 | |
| PPLNKID | Link ID | text | 200 | |
| PPLNKGRP | Link Group ID | text | 200 | |
| PPTESTCD | Parameter Short Name |
|
text | 200 |
| PPTEST | Parameter Name |
|
text | 200 |
| PPMODIFY | Modified Term | text | 200 | |
| PPTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| PPCAT | Parameter Category | text | 200 | |
| PPSCAT | Parameter Subcategory | text | 200 | |
| PPPOS | Position of Subject During Observation | text | 200 | |
| PPBODSYS | Body System or Organ Class | text | 200 | |
| PPORRES | Result or Finding in Original Units | text | 200 | |
| PPORRESU | Original Units | text | 200 | |
| PPORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PPORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PPSTRESC | Result or Finding in Standard Format | text | 200 | |
| PPSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| PPSTRESU | Standard Units | text | 200 | |
| PPSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| PPSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| PPSTNRC | Normal Range for Character Results | text | 200 | |
| PPNRIND | Normal/Reference Range Indicator | text | 200 | |
| PPRESCAT | Result Category | text | 200 | |
| PPSTAT | Completion Status | text | 200 | |
| PPREASND | Reason Parameter Not Calculated | text | 200 | |
| PPXFN | External File Path | text | 200 | |
| PPNAM | Laboratory/Vendor Name | text | 200 | |
| PPLOINC | LOINC Code | text | 200 | |
| PPSPEC | Specimen Material Type | text | 200 | |
| PPANTREG | Anatomical Region | text | 200 | |
| PPSPCCND | Specimen Condition | text | 200 | |
| PPSPCUFL | Specimen Usability for the Test | text | 200 | |
| PPLOC | Location Used for the Measurement | text | 200 | |
| PPLAT | Laterality | text | 200 | |
| PPDIR | Directionality | text | 200 | |
| PPPORTOT | Portion or Totality | text | 200 | |
| PPMETHOD | Method of Test or Examination | text | 200 | |
| PPRUNID | Run ID | text | 200 | |
| PPANMETH | Analysis Method | text | 200 | |
| PPLEAD | Lead Identified to Collect Measurements | text | 200 | |
| PPCSTATE | Consciousness State | text | 200 | |
| PPBLFL | Baseline Flag | text | 200 | |
| PPFAST | Fasting Status | text | 200 | |
| PPDRVFL | Derived Flag | text | 200 | |
| PPEVAL | Evaluator | text | 200 | |
| PPEVALID | Evaluator Identifier | text | 200 | |
| PPACPTFL | Accepted Record Flag | text | 200 | |
| PPTOX | Toxicity | text | 200 | |
| PPTOXGR | Toxicity Grade | text | 200 | |
| PPSEV | Severity | text | 200 | |
| PPDTHREL | Relationship to Death | text | 200 | |
| PPLLOQ | Lower Limit of Quantitation | float | 200 | |
| PPULOQ | Upper Limit of Quantitation | float | 200 | |
| PPEXCLFL | Exclude from Statistics | text | 200 | |
| PPREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PPDTC | Date/Time of Parameter Calculations | datetime | 200 | |
| PPSTDTC | Start Date/Time of Observation | datetime | 200 | |
| PPENDTC | End Date/Time of Observation | datetime | 200 | |
| PPDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| PPSTDY | Study Day of Start of Observation | integer | 200 | |
| PPENDY | Study Day of End of Observation | integer | 200 | |
| PPDUR | Duration | text | 200 | |
| PPTPT | Planned Time Point Name | text | 200 | |
| PPTPTNUM | Planned Time Point Number | float | 200 | |
| PPELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| PPTPTREF | Time Point Reference | text | 200 | |
| PPRFTDTC | Date/Time of Reference Point | datetime | 200 | |
| PPSTRF | Start Relative to Reference Period | text | 200 | |
| PPENRF | End Relative to Reference Period | text | 200 | |
| PPEVINTX | Evaluation Interval Text | text | 200 | |
| PPEVLINT | Evaluation Interval | text | 200 | |
| PPSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| PPSTTPT | Start Reference Time Point | text | 200 | |
| PPENRTPT | End Relative to Reference Time Point | text | 200 | |
| PPENTPT | End Reference Time Point | text | 200 | |
| PPSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| PPENINT | Planned End of Assessment Interval | datetime | 200 | |
| PPDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
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| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
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| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
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| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
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| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
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| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
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| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
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| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
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| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
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| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
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| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
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| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
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| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
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| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
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| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
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| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
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| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
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| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
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| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
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| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
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| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
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| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
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| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
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| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
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| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1036 | Toxicity Grade (--TOXGR) should be provided when Toxicity (--TOX) is populated. | Condition | Missing value for %Domain%TOXGR when %Domain%TOX is populated |
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| SD1037 | A value for a Toxicity (--TOX) variable should be provided when a Toxicity Grade (--TOXGR) variable value is populated and greater than 0. | Condition | Missing value for %Domain%TOX when %Domain%TOXGR is populated |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1348 | Planned Start of Assessment Interval (--STINT) and Planned End of Assessment Interval (--ENINT) variables should be present and populated when Name of Measurement, Test or Examination (--TEST) is over a time interval, 'T1 to T2', where 'T1' is represented by the value in --STINT and 'T2' is represented by the value in --ENINT. | Condition | Missing values for %Domain%STINT and %Domain%ENINT variables when %Domain%TEST references 'T1 to T2' |
|
|
| SD1350 | Planned End of Assessment Interval (--ENINT) should not be NULL when Planned Start of Assessment Interval (--STINT) is populated. | Required | Missing value for %Domain%ENINT when %Domain%STINT is provided |
|
|
| SD1351 | Planned Start of Assessment Interval (--STINT) should not be NULL when Planned End of Assessment Interval (--ENINT) is populated. | Required | Missing value for %Domain%STINT when %Domain%ENINT is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD1450 | Planned End of Assessment Interval (--ENINT) variable must be included in the domain when Planned Start of Assessment Interval (--STINT) variable is present. | Find | Missing %Domain%ENINT variable when %Domain%STINT variable is present |
|
|
| SD1451 | Planned Start of Assessment Interval (--STINT) variable must be included in the domain when Planned End of Assessment Interval (--ENINT) variable is present. | Find | Missing %Domain%STINT variable when %Domain%ENINT variable is present |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Questionnaires
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| QSSEQ | Sequence Number |
|
float | 200 |
| QSGRPID | Group ID | text | 200 | |
| QSREFID | Reference ID | text | 200 | |
| QSSPID | Sponsor-Defined Identifier | text | 200 | |
| QSLNKID | Link ID | text | 200 | |
| QSLNKGRP | Link Group ID | text | 200 | |
| QSTESTCD | Question Short Name |
|
text | 200 |
| QSTEST | Question Name |
|
text | 200 |
| QSMODIFY | Modified Term | text | 200 | |
| QSTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| QSCAT | Category of Question |
|
text | 200 |
| QSSCAT | Subcategory for Question | text | 200 | |
| QSPOS | Position of Subject During Observation | text | 200 | |
| QSBODSYS | Body System or Organ Class | text | 200 | |
| QSORRES | Finding in Original Units | text | 200 | |
| QSORRESU | Original Units | text | 200 | |
| QSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| QSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| QSSTRESC | Result or Finding in Standard Format | text | 200 | |
| QSSTRESN | Numeric Finding in Standard Units | float | 200 | |
| QSSTRESU | Standard Units | text | 200 | |
| QSSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| QSSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| QSSTNRC | Normal Range for Character Results | text | 200 | |
| QSNRIND | Normal/Reference Range Indicator | text | 200 | |
| QSRESCAT | Result Category | text | 200 | |
| QSSTAT | Completion Status | text | 200 | |
| QSREASND | Reason Not Performed | text | 200 | |
| QSXFN | External File Path | text | 200 | |
| QSNAM | Laboratory/Vendor Name | text | 200 | |
| QSLOINC | LOINC Code | text | 200 | |
| QSSPEC | Specimen Material Type | text | 200 | |
| QSANTREG | Anatomical Region | text | 200 | |
| QSSPCCND | Specimen Condition | text | 200 | |
| QSSPCUFL | Specimen Usability for the Test | text | 200 | |
| QSLOC | Location Used for the Measurement | text | 200 | |
| QSLAT | Laterality | text | 200 | |
| QSDIR | Directionality | text | 200 | |
| QSPORTOT | Portion or Totality | text | 200 | |
| QSMETHOD | Method of Test or Examination | text | 200 | |
| QSRUNID | Run ID | text | 200 | |
| QSANMETH | Analysis Method | text | 200 | |
| QSLEAD | Lead Identified to Collect Measurements | text | 200 | |
| QSCSTATE | Consciousness State | text | 200 | |
| QSBLFL | Baseline Flag | text | 200 | |
| QSFAST | Fasting Status | text | 200 | |
| QSDRVFL | Derived Flag | text | 200 | |
| QSEVAL | Evaluator | text | 200 | |
| QSEVALID | Evaluator Identifier | text | 200 | |
| QSACPTFL | Accepted Record Flag | text | 200 | |
| QSTOX | Toxicity | text | 200 | |
| QSTOXGR | Toxicity Grade | text | 200 | |
| QSSEV | Severity | text | 200 | |
| QSDTHREL | Relationship to Death | text | 200 | |
| QSLLOQ | Lower Limit of Quantitation | float | 200 | |
| QSULOQ | Upper Limit of Quantitation | float | 200 | |
| QSEXCLFL | Exclude from Statistics | text | 200 | |
| QSREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| QSDTC | Date/Time of Finding | datetime | 200 | |
| QSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| QSENDTC | End Date/Time of Observation | datetime | 200 | |
| QSDY | Study Day of Finding | integer | 200 | |
| QSSTDY | Study Day of Start of Observation | integer | 200 | |
| QSENDY | Study Day of End of Observation | integer | 200 | |
| QSDUR | Duration | text | 200 | |
| QSTPT | Planned Time Point Name | text | 200 | |
| QSTPTNUM | Planned Time Point Number | float | 200 | |
| QSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| QSTPTREF | Time Point Reference | text | 200 | |
| QSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| QSSTRF | Start Relative to Reference Period | text | 200 | |
| QSENRF | End Relative to Reference Period | text | 200 | |
| QSEVLINT | Evaluation Interval | text | 200 | |
| QSEVINTX | Evaluation Interval Text | text | 200 | |
| QSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| QSSTTPT | Start Reference Time Point | text | 200 | |
| QSENRTPT | End Relative to Reference Time Point | text | 200 | |
| QSENTPT | End Reference Time Point | text | 200 | |
| QSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| QSENINT | Planned End of Assessment Interval | datetime | 200 | |
| QSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Reproductive System Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| RPSEQ | Sequence Number |
|
float | 200 |
| RPGRPID | Group ID | text | 200 | |
| RPREFID | Reference ID | text | 200 | |
| RPSPID | Sponsor-Defined Identifier | text | 200 | |
| RPLNKID | Link ID | text | 200 | |
| RPLNKGRP | Link Group ID | text | 200 | |
| RPTESTCD | Repro System Findings Test Short Name |
|
text | 200 |
| RPTEST | Reproductive System Findings Test Name |
|
text | 200 |
| RPMODIFY | Modified Term | text | 200 | |
| RPTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| RPCAT | Category for Repro System Findings | text | 200 | |
| RPSCAT | Subcategory for Repro System Findings | text | 200 | |
| RPPOS | Position of Subject During Observation | text | 200 | |
| RPBODSYS | Body System or Organ Class | text | 200 | |
| RPORRES | Result or Finding in Original Units | text | 200 | |
| RPORRESU | Original Units | text | 200 | |
| RPORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| RPORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| RPSTRESC | Character Result/Finding in Std. Format | text | 200 | |
| RPSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| RPSTRESU | Standard Units | text | 200 | |
| RPSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| RPSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| RPSTNRC | Normal Range for Character Results | text | 200 | |
| RPNRIND | Normal/Reference Range Indicator | text | 200 | |
| RPRESCAT | Result Category | text | 200 | |
| RPSTAT | Completion Status | text | 200 | |
| RPREASND | Reason Not Performed | text | 200 | |
| RPXFN | External File Path | text | 200 | |
| RPNAM | Laboratory/Vendor Name | text | 200 | |
| RPLOINC | LOINC Code | text | 200 | |
| RPSPEC | Specimen Material Type | text | 200 | |
| RPANTREG | Anatomical Region | text | 200 | |
| RPSPCCND | Specimen Condition | text | 200 | |
| RPSPCUFL | Specimen Usability for the Test | text | 200 | |
| RPLOC | Location Used for the Measurement | text | 200 | |
| RPLAT | Laterality | text | 200 | |
| RPDIR | Directionality | text | 200 | |
| RPPORTOT | Portion or Totality | text | 200 | |
| RPMETHOD | Method of Test or Examination | text | 200 | |
| RPRUNID | Run ID | text | 200 | |
| RPANMETH | Analysis Method | text | 200 | |
| RPLEAD | Lead Identified to Collect Measurements | text | 200 | |
| RPCSTATE | Consciousness State | text | 200 | |
| RPBLFL | Baseline Flag | text | 200 | |
| RPFAST | Fasting Status | text | 200 | |
| RPDRVFL | Derived Flag | text | 200 | |
| RPEVAL | Evaluator | text | 200 | |
| RPEVALID | Evaluator Identifier | text | 200 | |
| RPACPTFL | Accepted Record Flag | text | 200 | |
| RPTOX | Toxicity | text | 200 | |
| RPTOXGR | Toxicity Grade | text | 200 | |
| RPSEV | Severity | text | 200 | |
| RPDTHREL | Relationship to Death | text | 200 | |
| RPLLOQ | Lower Limit of Quantitation | float | 200 | |
| RPULOQ | Upper Limit of Quantitation | float | 200 | |
| RPEXCLFL | Exclude from Statistics | text | 200 | |
| RPREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| RPDTC | Date/Time of Measurements | datetime | 200 | |
| RPSTDTC | Start Date/Time of Observation | datetime | 200 | |
| RPENDTC | End Date/Time of Observation | datetime | 200 | |
| RPDY | Study Day of Repro System Findings | integer | 200 | |
| RPSTDY | Study Day of Start of Observation | integer | 200 | |
| RPENDY | Study Day of End of Observation | integer | 200 | |
| RPDUR | Duration | text | 200 | |
| RPTPT | Planned Time Point Name | text | 200 | |
| RPTPTNUM | Planned Time Point Number | float | 200 | |
| RPELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| RPTPTREF | Time Point Reference | text | 200 | |
| RPRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| RPSTRF | Start Relative to Reference Period | text | 200 | |
| RPENRF | End Relative to Reference Period | text | 200 | |
| RPEVLINT | Evaluation Interval | text | 200 | |
| RPEVINTX | Evaluation Interval Text | text | 200 | |
| RPSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| RPSTTPT | Start Reference Time Point | text | 200 | |
| RPENRTPT | End Relative to Reference Time Point | text | 200 | |
| RPENTPT | End Reference Time Point | text | 200 | |
| RPSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| RPENINT | Planned End of Assessment Interval | datetime | 200 | |
| RPDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Disease Response
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| RSSEQ | Sequence Number |
|
float | 200 |
| RSGRPID | Group ID | text | 200 | |
| RSREFID | Reference ID | text | 200 | |
| RSSPID | Sponsor-Defined Identifier | text | 200 | |
| RSLNKID | Link ID | text | 200 | |
| RSLNKGRP | Link Group | text | 200 | |
| RSTESTCD | Response Assessment Short Name |
|
text | 200 |
| RSTEST | Response Assessment Name |
|
text | 200 |
| RSMODIFY | Modified Term | text | 200 | |
| RSTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| RSCAT | Category for Response Assessment | text | 200 | |
| RSSCAT | Subcategory | text | 200 | |
| RSPOS | Position of Subject During Observation | text | 200 | |
| RSBODSYS | Body System or Organ Class | text | 200 | |
| RSORRES | Response Assessment Original Result | text | 200 | |
| RSORRESU | Original Units | text | 200 | |
| RSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| RSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| RSSTRESC | Response Assessment Result in Std Format | text | 200 | |
| RSSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| RSSTRESU | Standard Units | text | 200 | |
| RSSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| RSSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| RSSTNRC | Normal Range for Character Results | text | 200 | |
| RSNRIND | Normal/Reference Range Indicator | text | 200 | |
| RSRESCAT | Result Category | text | 200 | |
| RSSTAT | Completion Status | text | 200 | |
| RSREASND | Reason Response Assessment Not Performed | text | 200 | |
| RSXFN | External File Path | text | 200 | |
| RSNAM | Vendor Name | text | 200 | |
| RSLOINC | LOINC Code | text | 200 | |
| RSSPEC | Specimen Material Type | text | 200 | |
| RSANTREG | Anatomical Region | text | 200 | |
| RSSPCCND | Specimen Condition | text | 200 | |
| RSSPCUFL | Specimen Usability for the Test | text | 200 | |
| RSLOC | Location Used for the Measurement | text | 200 | |
| RSLAT | Laterality | text | 200 | |
| RSDIR | Directionality | text | 200 | |
| RSPORTOT | Portion or Totality | text | 200 | |
| RSMETHOD | Method of Test or Examination | text | 200 | |
| RSRUNID | Run ID | text | 200 | |
| RSANMETH | Analysis Method | text | 200 | |
| RSLEAD | Lead Identified to Collect Measurements | text | 200 | |
| RSCSTATE | Consciousness State | text | 200 | |
| RSBLFL | Baseline Flag | text | 200 | |
| RSFAST | Fasting Status | text | 200 | |
| RSDRVFL | Derived Flag | text | 200 | |
| RSEVAL | Evaluator | text | 200 | |
| RSEVALID | Evaluator Identifier | text | 200 | |
| RSACPTFL | Accepted Record Flag | text | 200 | |
| RSTOX | Toxicity | text | 200 | |
| RSTOXGR | Toxicity Grade | text | 200 | |
| RSSEV | Severity | text | 200 | |
| RSDTHREL | Relationship to Death | text | 200 | |
| RSLLOQ | Lower Limit of Quantitation | float | 200 | |
| RSULOQ | Upper Limit of Quantitation | float | 200 | |
| RSEXCLFL | Exclude from Statistics | text | 200 | |
| RSREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| RSDTC | Date/Time of Response Assessment | datetime | 200 | |
| RSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| RSENDTC | End Date/Time of Observation | datetime | 200 | |
| RSDY | Study Day of Response Assessment | integer | 200 | |
| RSSTDY | Study Day of Start of Observation | integer | 200 | |
| RSENDY | Study Day of End of Observation | integer | 200 | |
| RSDUR | Duration | text | 200 | |
| RSTPT | Planned Time Point Name | text | 200 | |
| RSTPTNUM | Planned Time Point Number | float | 200 | |
| RSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| RSTPTREF | Time Point Reference | text | 200 | |
| RSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| RSSTRF | Start Relative to Reference Period | text | 200 | |
| RSENRF | End Relative to Reference Period | text | 200 | |
| RSEVLINT | Evaluation Interval | text | 200 | |
| RSEVINTX | Evaluation Interval Text | text | 200 | |
| RSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| RSSTTPT | Start Reference Time Point | text | 200 | |
| RSENRTPT | End Relative to Reference Time Point | text | 200 | |
| RSENTPT | End Reference Time Point | text | 200 | |
| RSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| RSENINT | Planned End of Assessment Interval | datetime | 200 | |
| RSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1337 | A Link ID (RSLNKID) value for a response assessment that is referenced in the Disease Response (RS) domain for a subject must also be present in the Tumor Results (TR) domain for the appropriate measurement records for that subject. | Lookup | RSLNKID value does not exist in TR domain |
|
|
| SD1338 | A Link Group (RSLNKGRP) value for a response assessment that is referenced in the Disease Response (RS) domain for a subject must also be present in the Tumor Results (TR) domain for the appropriate measurement records for that subject. | Lookup | RSLNKGRP value does not exist in TR domain |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Subject Characteristics
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| SCSEQ | Sequence Number |
|
float | 200 |
| SCGRPID | Group ID | text | 200 | |
| SCREFID | Reference ID | text | 200 | |
| SCSPID | Sponsor-Defined Identifier | text | 200 | |
| SCLNKID | Link ID | text | 200 | |
| SCLNKGRP | Link Group ID | text | 200 | |
| SCTESTCD | Subject Characteristic Short Name |
|
text | 200 |
| SCTEST | Subject Characteristic |
|
text | 200 |
| SCMODIFY | Modified Term | text | 200 | |
| SCTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| SCCAT | Category for Subject Characteristic | text | 200 | |
| SCSCAT | Subcategory for Subject Characteristic | text | 200 | |
| SCPOS | Position of Subject During Observation | text | 200 | |
| SCBODSYS | Body System or Organ Class | text | 200 | |
| SCORRES | Result or Finding in Original Units | text | 200 | |
| SCORRESU | Original Units | text | 200 | |
| SCORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| SCORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| SCSTRESC | Character Result/Finding in Std Format | text | 200 | |
| SCSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| SCSTRESU | Standard Units | text | 200 | |
| SCSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| SCSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| SCSTNRC | Normal Range for Character Results | text | 200 | |
| SCNRIND | Normal/Reference Range Indicator | text | 200 | |
| SCRESCAT | Result Category | text | 200 | |
| SCSTAT | Completion Status | text | 200 | |
| SCREASND | Reason Not Performed | text | 200 | |
| SCXFN | External File Path | text | 200 | |
| SCNAM | Laboratory/Vendor Name | text | 200 | |
| SCLOINC | LOINC Code | text | 200 | |
| SCSPEC | Specimen Material Type | text | 200 | |
| SCANTREG | Anatomical Region | text | 200 | |
| SCSPCCND | Specimen Condition | text | 200 | |
| SCSPCUFL | Specimen Usability for the Test | text | 200 | |
| SCLOC | Location Used for the Measurement | text | 200 | |
| SCLAT | Laterality | text | 200 | |
| SCDIR | Directionality | text | 200 | |
| SCPORTOT | Portion or Totality | text | 200 | |
| SCMETHOD | Method of Test or Examination | text | 200 | |
| SCRUNID | Run ID | text | 200 | |
| SCANMETH | Analysis Method | text | 200 | |
| SCLEAD | Lead Identified to Collect Measurements | text | 200 | |
| SCCSTATE | Consciousness State | text | 200 | |
| SCBLFL | Baseline Flag | text | 200 | |
| SCFAST | Fasting Status | text | 200 | |
| SCDRVFL | Derived Flag | text | 200 | |
| SCEVAL | Evaluator | text | 200 | |
| SCEVALID | Evaluator Identifier | text | 200 | |
| SCACPTFL | Accepted Record Flag | text | 200 | |
| SCTOX | Toxicity | text | 200 | |
| SCTOXGR | Toxicity Grade | text | 200 | |
| SCSEV | Severity | text | 200 | |
| SCDTHREL | Relationship to Death | text | 200 | |
| SCLLOQ | Lower Limit of Quantitation | float | 200 | |
| SCULOQ | Upper Limit of Quantitation | float | 200 | |
| SCEXCLFL | Exclude from Statistics | text | 200 | |
| SCREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SCDTC | Date/Time of Collection | datetime | 200 | |
| SCSTDTC | Start Date/Time of Observation | datetime | 200 | |
| SCENDTC | End Date/Time of Observation | datetime | 200 | |
| SCDY | Study Day of Examination | integer | 200 | |
| SCSTDY | Study Day of Start of Observation | integer | 200 | |
| SCENDY | Study Day of End of Observation | integer | 200 | |
| SCDUR | Duration | text | 200 | |
| SCTPT | Planned Time Point Name | text | 200 | |
| SCTPTNUM | Planned Time Point Number | float | 200 | |
| SCELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SCTPTREF | Time Point Reference | text | 200 | |
| SCRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SCSTRF | Start Relative to Reference Period | text | 200 | |
| SCENRF | End Relative to Reference Period | text | 200 | |
| SCEVLINT | Evaluation Interval | text | 200 | |
| SCEVINTX | Evaluation Interval Text | text | 200 | |
| SCSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SCSTTPT | Start Reference Time Point | text | 200 | |
| SCENRTPT | End Relative to Reference Time Point | text | 200 | |
| SCENTPT | End Reference Time Point | text | 200 | |
| SCSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| SCENINT | Planned End of Assessment Interval | datetime | 200 | |
| SCDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
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Subject Status
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| SSSEQ | Sequence Number |
|
float | 200 |
| SSGRPID | Group ID | text | 200 | |
| SSREFID | Reference ID | text | 200 | |
| SSSPID | Sponsor-Defined Identifier | text | 200 | |
| SSLNKID | Link ID | text | 200 | |
| SSLNKGRP | Link Group ID | text | 200 | |
| SSTESTCD | Status Short Name |
|
text | 200 |
| SSTEST | Status Name |
|
text | 200 |
| SSMODIFY | Modified Term | text | 200 | |
| SSTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| SSCAT | Category for Assessment | text | 200 | |
| SSSCAT | Subcategory for Assessment | text | 200 | |
| SSPOS | Position of Subject During Observation | text | 200 | |
| SSBODSYS | Body System or Organ Class | text | 200 | |
| SSORRES | Result or Finding Original Result | text | 200 | |
| SSORRESU | Original Units | text | 200 | |
| SSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| SSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| SSSTRESC | Character Result/Finding in Std Format | text | 200 | |
| SSSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| SSSTRESU | Standard Units | text | 200 | |
| SSSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| SSSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| SSSTNRC | Normal Range for Character Results | text | 200 | |
| SSNRIND | Normal/Reference Range Indicator | text | 200 | |
| SSRESCAT | Result Category | text | 200 | |
| SSSTAT | Completion Status | text | 200 | |
| SSREASND | Reason Assessment Not Performed | text | 200 | |
| SSXFN | External File Path | text | 200 | |
| SSNAM | Laboratory/Vendor Name | text | 200 | |
| SSLOINC | LOINC Code | text | 200 | |
| SSSPEC | Specimen Material Type | text | 200 | |
| SSANTREG | Anatomical Region | text | 200 | |
| SSSPCCND | Specimen Condition | text | 200 | |
| SSSPCUFL | Specimen Usability for the Test | text | 200 | |
| SSLOC | Location Used for the Measurement | text | 200 | |
| SSLAT | Laterality | text | 200 | |
| SSDIR | Directionality | text | 200 | |
| SSPORTOT | Portion or Totality | text | 200 | |
| SSMETHOD | Method of Test or Examination | text | 200 | |
| SSRUNID | Run ID | text | 200 | |
| SSANMETH | Analysis Method | text | 200 | |
| SSLEAD | Lead Identified to Collect Measurements | text | 200 | |
| SSCSTATE | Consciousness State | text | 200 | |
| SSBLFL | Baseline Flag | text | 200 | |
| SSFAST | Fasting Status | text | 200 | |
| SSDRVFL | Derived Flag | text | 200 | |
| SSEVAL | Evaluator | text | 200 | |
| SSEVALID | Evaluator Identifier | text | 200 | |
| SSACPTFL | Accepted Record Flag | text | 200 | |
| SSTOX | Toxicity | text | 200 | |
| SSTOXGR | Toxicity Grade | text | 200 | |
| SSSEV | Severity | text | 200 | |
| SSDTHREL | Relationship to Death | text | 200 | |
| SSLLOQ | Lower Limit of Quantitation | float | 200 | |
| SSULOQ | Upper Limit of Quantitation | float | 200 | |
| SSEXCLFL | Exclude from Statistics | text | 200 | |
| SSREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SSDTC | Date/Time of Assessment | datetime | 200 | |
| SSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| SSENDTC | End Date/Time of Observation | datetime | 200 | |
| SSDY | Study Day of Assessment | integer | 200 | |
| SSSTDY | Study Day of Start of Observation | integer | 200 | |
| SSENDY | Study Day of End of Observation | integer | 200 | |
| SSDUR | Duration | text | 200 | |
| SSTPT | Planned Time Point Name | text | 200 | |
| SSTPTNUM | Planned Time Point Number | float | 200 | |
| SSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SSTPTREF | Time Point Reference | text | 200 | |
| SSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SSSTRF | Start Relative to Reference Period | text | 200 | |
| SSENRF | End Relative to Reference Period | text | 200 | |
| SSEVLINT | Evaluation Interval | text | 200 | |
| SSEVINTX | Evaluation Interval Text | text | 200 | |
| SSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SSSTTPT | Start Reference Time Point | text | 200 | |
| SSENRTPT | End Relative to Reference Time Point | text | 200 | |
| SSENTPT | End Reference Time Point | text | 200 | |
| SSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| SSENINT | Planned End of Assessment Interval | datetime | 200 | |
| SSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
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| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
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| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
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| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
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| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
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| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
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| SD0001 | Domain table should have at least one record. | Property | No records in data source |
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| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
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| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
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| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
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| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
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| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
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| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
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| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
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| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
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| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
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| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
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| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
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| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
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| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
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| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
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| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
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| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
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| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
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| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
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| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
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| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
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| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
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| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
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| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
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| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
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| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
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| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
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| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
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| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
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| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
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| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
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| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
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| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
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| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
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| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
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| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
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| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
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| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
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| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
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| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
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| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
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| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
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| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
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| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
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| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
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| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
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| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
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| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
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| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
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| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
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| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
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| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
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| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
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| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
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| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
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| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
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| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
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| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
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| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
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| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
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| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
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| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
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| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1252 | DTHFL must equal 'Y' when there is a record in the Subject Status (SS) domain with SSSTRESC = 'DEAD'. | Lookup | DTHFL does not equal 'Y' when SS.SSSTRESC = 'DEAD' |
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| SD1261 | Subject Status Date/Time of Assessment (SSDTC) must be greater than or equal to Date/Time of Death (DTHDTC) when the subject's status is 'DEAD'. | Condition | SSDTC is not greater than or equal to DTHDTC when SSSTRESC = 'DEAD' |
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| SD1262 | Subject Status Date/Time of Assessment (SSDTC) must be greater than or equal to Start Date/Time of Disposition Event (DSSTDTC) when the subject's status is 'DEAD'. | Condition | SSDTC is not greater than or equal to DSSTDTC when SSSTRESC = 'DEAD' |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1316 | All subjects who have Death records (SSSTRESC = 'DEAD') in Survival Status (SS) domain should also have death records (DSDECOD='DEATH') in Disposition (DS) domain. | Lookup | Missing 'DEATH' record for subject in DS domain |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Tumor Results
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| TRSEQ | Sequence Number |
|
float | 200 |
| TRGRPID | Group ID | text | 200 | |
| TRREFID | Reference ID | text | 200 | |
| TRSPID | Sponsor-Defined Identifier | text | 200 | |
| TRLNKID | Link ID | text | 200 | |
| TRLNKGRP | Link Group | text | 200 | |
| TRTESTCD | Tumor Assessment Short Name |
|
text | 200 |
| TRTEST | Tumor Assessment Test Name |
|
text | 200 |
| TRMODIFY | Modified Term | text | 200 | |
| TRTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| TRCAT | Category | text | 200 | |
| TRSCAT | Subcategory | text | 200 | |
| TRPOS | Position of Subject During Observation | text | 200 | |
| TRBODSYS | Body System or Organ Class | text | 200 | |
| TRORRES | Result or Finding in Original Units | text | 200 | |
| TRORRESU | Original Units | text | 200 | |
| TRORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| TRORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| TRSTRESC | Character Result/Finding in Std Format | text | 200 | |
| TRSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| TRSTRESU | Standard Units | text | 200 | |
| TRSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| TRSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| TRSTNRC | Normal Range for Character Results | text | 200 | |
| TRNRIND | Normal/Reference Range Indicator | text | 200 | |
| TRRESCAT | Result Category | text | 200 | |
| TRSTAT | Completion Status | text | 200 | |
| TRREASND | Reason Tumor Measurement Not Performed | text | 200 | |
| TRXFN | External File Path | text | 200 | |
| TRNAM | Vendor Name | text | 200 | |
| TRLOINC | LOINC Code | text | 200 | |
| TRSPEC | Specimen Material Type | text | 200 | |
| TRANTREG | Anatomical Region | text | 200 | |
| TRSPCCND | Specimen Condition | text | 200 | |
| TRSPCUFL | Specimen Usability for the Test | text | 200 | |
| TRLOC | Location Used for the Measurement | text | 200 | |
| TRLAT | Laterality | text | 200 | |
| TRDIR | Directionality | text | 200 | |
| TRPORTOT | Portion or Totality | text | 200 | |
| TRMETHOD | Method used to Identify the Tumor | text | 200 | |
| TRRUNID | Run ID | text | 200 | |
| TRANMETH | Analysis Method | text | 200 | |
| TRLEAD | Lead Identified to Collect Measurements | text | 200 | |
| TRCSTATE | Consciousness State | text | 200 | |
| TRBLFL | Baseline Flag | text | 200 | |
| TRFAST | Fasting Status | text | 200 | |
| TRDRVFL | Derived Flag | text | 200 | |
| TREVAL | Evaluator | text | 200 | |
| TREVALID | Evaluator Identifier | text | 200 | |
| TRACPTFL | Accepted Record Flag | text | 200 | |
| TRTOX | Toxicity | text | 200 | |
| TRTOXGR | Toxicity Grade | text | 200 | |
| TRSEV | Severity | text | 200 | |
| TRDTHREL | Relationship to Death | text | 200 | |
| TRLLOQ | Lower Limit of Quantitation | float | 200 | |
| TRULOQ | Upper Limit of Quantitation | float | 200 | |
| TREXCLFL | Exclude from Statistics | text | 200 | |
| TRREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| TRDTC | Date/Time of Tumor Measurement | datetime | 200 | |
| TRSTDTC | Start Date/Time of Observation | datetime | 200 | |
| TRENDTC | End Date/Time of Observation | datetime | 200 | |
| TRDY | Study Day of Tumor Measurement | integer | 200 | |
| TRSTDY | Study Day of Start of Observation | integer | 200 | |
| TRENDY | Study Day of End of Observation | integer | 200 | |
| TRDUR | Duration | text | 200 | |
| TRTPT | Planned Time Point Name | text | 200 | |
| TRTPTNUM | Planned Time Point Number | float | 200 | |
| TRELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| TRTPTREF | Time Point Reference | text | 200 | |
| TRRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| TRSTRF | Start Relative to Reference Period | text | 200 | |
| TRENRF | End Relative to Reference Period | text | 200 | |
| TREVLINT | Evaluation Interval | text | 200 | |
| TREVINTX | Evaluation Interval Text | text | 200 | |
| TRSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| TRSTTPT | Start Reference Time Point | text | 200 | |
| TRENRTPT | End Relative to Reference Time Point | text | 200 | |
| TRENTPT | End Reference Time Point | text | 200 | |
| TRSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| TRENINT | Planned End of Assessment Interval | datetime | 200 | |
| TRDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1336 | A Link ID (TRLNKID) value for a tumor that is referenced in the Tumor Results (TR) domain for a subject must also be present in the Tumor Identification (TU) domain for that subject. | Lookup | TRLNKID value does not exist in TU domain |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Tumor Identification
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| TUSEQ | Sequence Number |
|
float | 200 |
| TUGRPID | Group ID | text | 200 | |
| TUREFID | Reference ID | text | 200 | |
| TUSPID | Sponsor-Defined Identifier | text | 200 | |
| TULNKID | Link ID | text | 200 | |
| TULNKGRP | Link Group ID | text | 200 | |
| TUTESTCD | Tumor Identification Short Name |
|
text | 200 |
| TUTEST | Tumor Identification Test Name |
|
text | 200 |
| TUMODIFY | Modified Term | text | 200 | |
| TUTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| TUCAT | Category | text | 200 | |
| TUSCAT | Subcategory | text | 200 | |
| TUPOS | Position of Subject During Observation | text | 200 | |
| TUBODSYS | Body System or Organ Class | text | 200 | |
| TUORRES | Tumor Identification Result | text | 200 | |
| TUORRESU | Original Units | text | 200 | |
| TUORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| TUORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| TUSTRESC | Tumor Identification Result Std. Format | text | 200 | |
| TUSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| TUSTRESU | Standard Units | text | 200 | |
| TUSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| TUSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| TUSTNRC | Normal Range for Character Results | text | 200 | |
| TUNRIND | Normal/Reference Range Indicator | text | 200 | |
| TURESCAT | Result Category | text | 200 | |
| TUSTAT | Completion Status | text | 200 | |
| TUREASND | Reason Not Done | text | 200 | |
| TUXFN | External File Path | text | 200 | |
| TUNAM | Vendor Name | text | 200 | |
| TULOINC | LOINC Code | text | 200 | |
| TUSPEC | Specimen Material Type | text | 200 | |
| TUANTREG | Anatomical Region | text | 200 | |
| TUSPCCND | Specimen Condition | text | 200 | |
| TUSPCUFL | Specimen Usability for the Test | text | 200 | |
| TULOC | Location of the Tumor | text | 200 | |
| TULAT | Laterality | text | 200 | |
| TUDIR | Directionality | text | 200 | |
| TUPORTOT | Portion or Totality | text | 200 | |
| TUMETHOD | Method of Identification | text | 200 | |
| TURUNID | Run ID | text | 200 | |
| TUANMETH | Analysis Method | text | 200 | |
| TULEAD | Lead Identified to Collect Measurements | text | 200 | |
| TUCSTATE | Consciousness State | text | 200 | |
| TUBLFL | Baseline Flag | text | 200 | |
| TUFAST | Fasting Status | text | 200 | |
| TUDRVFL | Derived Flag | text | 200 | |
| TUEVAL | Evaluator | text | 200 | |
| TUEVALID | Evaluator Identifier | text | 200 | |
| TUACPTFL | Accepted Record Flag | text | 200 | |
| TUTOX | Toxicity | text | 200 | |
| TUTOXGR | Toxicity Grade | text | 200 | |
| TUSEV | Severity | text | 200 | |
| TUDTHREL | Relationship to Death | text | 200 | |
| TULLOQ | Lower Limit of Quantitation | float | 200 | |
| TUULOQ | Upper Limit of Quantitation | float | 200 | |
| TUEXCLFL | Exclude from Statistics | text | 200 | |
| TUREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| TUDTC | Date/Time of Tumor Identification | datetime | 200 | |
| TUSTDTC | Start Date/Time of Observation | datetime | 200 | |
| TUENDTC | End Date/Time of Observation | datetime | 200 | |
| TUDY | Study Day of Tumor Identification | integer | 200 | |
| TUSTDY | Study Day of Start of Observation | integer | 200 | |
| TUENDY | Study Day of End of Observation | integer | 200 | |
| TUDUR | Duration | text | 200 | |
| TUTPT | Planned Time Point Name | text | 200 | |
| TUTPTNUM | Planned Time Point Number | float | 200 | |
| TUELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| TUTPTREF | Time Point Reference | text | 200 | |
| TURFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| TUSTRF | Start Relative to Reference Period | text | 200 | |
| TUENRF | End Relative to Reference Period | text | 200 | |
| TUEVLINT | Evaluation Interval | text | 200 | |
| TUEVINTX | Evaluation Interval Text | text | 200 | |
| TUSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| TUSTTPT | Start Reference Time Point | text | 200 | |
| TUENRTPT | End Relative to Reference Time Point | text | 200 | |
| TUENTPT | End Reference Time Point | text | 200 | |
| TUSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| TUENINT | Planned End of Assessment Interval | datetime | 200 | |
| TUDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Vital Signs
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| VSSEQ | Sequence Number |
|
float | 200 |
| VSGRPID | Group ID | text | 200 | |
| VSREFID | Reference ID | text | 200 | |
| VSSPID | Sponsor-Defined Identifier | text | 200 | |
| VSLNKID | Link ID | text | 200 | |
| VSLNKGRP | Link Group ID | text | 200 | |
| VSTESTCD | Vital Signs Test Short Name |
|
text | 200 |
| VSTEST | Vital Signs Test Name |
|
text | 200 |
| VSMODIFY | Modified Term | text | 200 | |
| VSTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| VSCAT | Category for Vital Signs | text | 200 | |
| VSSCAT | Subcategory for Vital Signs | text | 200 | |
| VSPOS | Vital Signs Position of Subject | text | 200 | |
| VSBODSYS | Body System or Organ Class | text | 200 | |
| VSORRES | Result or Finding in Original Units | text | 200 | |
| VSORRESU | Original Units | text | 200 | |
| VSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| VSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| VSSTRESC | Character Result/Finding in Std Format | text | 200 | |
| VSSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| VSSTRESU | Standard Units | text | 200 | |
| VSSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| VSSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| VSSTNRC | Normal Range for Character Results | text | 200 | |
| VSNRIND | Normal/Reference Range Indicator | text | 200 | |
| VSRESCAT | Result Category | text | 200 | |
| VSSTAT | Completion Status | text | 200 | |
| VSREASND | Reason Not Performed | text | 200 | |
| VSXFN | External File Path | text | 200 | |
| VSNAM | Laboratory/Vendor Name | text | 200 | |
| VSLOINC | LOINC Code | text | 200 | |
| VSSPEC | Specimen Material Type | text | 200 | |
| VSANTREG | Anatomical Region | text | 200 | |
| VSSPCCND | Specimen Condition | text | 200 | |
| VSSPCUFL | Specimen Usability for the Test | text | 200 | |
| VSLOC | Location of Vital Signs Measurement | text | 200 | |
| VSLAT | Laterality | text | 200 | |
| VSDIR | Directionality | text | 200 | |
| VSPORTOT | Portion or Totality | text | 200 | |
| VSMETHOD | Method of Test or Examination | text | 200 | |
| VSRUNID | Run ID | text | 200 | |
| VSANMETH | Analysis Method | text | 200 | |
| VSLEAD | Lead Identified to Collect Measurements | text | 200 | |
| VSCSTATE | Consciousness State | text | 200 | |
| VSBLFL | Baseline Flag | text | 200 | |
| VSFAST | Fasting Status | text | 200 | |
| VSDRVFL | Derived Flag | text | 200 | |
| VSEVAL | Evaluator | text | 200 | |
| VSEVALID | Evaluator Identifier | text | 200 | |
| VSACPTFL | Accepted Record Flag | text | 200 | |
| VSTOX | Toxicity | text | 200 | |
| VSTOXGR | Toxicity Grade | text | 200 | |
| VSSEV | Severity | text | 200 | |
| VSDTHREL | Relationship to Death | text | 200 | |
| VSLLOQ | Lower Limit of Quantitation | float | 200 | |
| VSULOQ | Upper Limit of Quantitation | float | 200 | |
| VSEXCLFL | Exclude from Statistics | text | 200 | |
| VSREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| VSDTC | Date/Time of Measurements | datetime | 200 | |
| VSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| VSENDTC | End Date/Time of Observation | datetime | 200 | |
| VSDY | Study Day of Vital Signs | integer | 200 | |
| VSSTDY | Study Day of Start of Observation | integer | 200 | |
| VSENDY | Study Day of End of Observation | integer | 200 | |
| VSDUR | Duration | text | 200 | |
| VSTPT | Planned Time Point Name | text | 200 | |
| VSTPTNUM | Planned Time Point Number | float | 200 | |
| VSELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| VSTPTREF | Time Point Reference | text | 200 | |
| VSRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| VSSTRF | Start Relative to Reference Period | text | 200 | |
| VSENRF | End Relative to Reference Period | text | 200 | |
| VSEVLINT | Evaluation Interval | text | 200 | |
| VSEVINTX | Evaluation Interval Text | text | 200 | |
| VSSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| VSSTTPT | Start Reference Time Point | text | 200 | |
| VSENRTPT | End Relative to Reference Time Point | text | 200 | |
| VSENTPT | End Reference Time Point | text | 200 | |
| VSSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| VSENINT | Planned End of Assessment Interval | datetime | 200 | |
| VSDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
|
| SD2285 | Value for the LOINC Code (--LOINC) variable must be populated using a LOINC coding system version specified in the define.xml. | Lookup | Value for %Domain%LOINC not found in LOINC coding system |
|
Findings About Events or Interventions
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FASEQ | Sequence Number |
|
float | 200 |
| FAGRPID | Group ID | text | 200 | |
| FAREFID | Reference ID | text | 200 | |
| FASPID | Sponsor-Defined Identifier | text | 200 | |
| FALNKID | Link ID | text | 200 | |
| FALNKGRP | Link Group ID | text | 200 | |
| FATESTCD | Findings About Test Short Name |
|
text | 200 |
| FATEST | Findings About Test Name |
|
text | 200 |
| FAOBJ | Object of the Observation |
|
text | 200 |
| FAMODIFY | Modified Term | text | 200 | |
| FATSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| FACAT | Category for Findings About | text | 200 | |
| FASCAT | Subcategory for Findings About | text | 200 | |
| FAPOS | Position of Subject During Observation | text | 200 | |
| FABODSYS | Body System or Organ Class | text | 200 | |
| FAORRES | Result or Finding in Original Units | text | 200 | |
| FAORRESU | Original Units | text | 200 | |
| FAORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| FAORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| FASTRESC | Character Result/Finding in Std Format | text | 200 | |
| FASTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| FASTRESU | Standard Units | text | 200 | |
| FASTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| FASTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| FASTNRC | Normal Range for Character Results | text | 200 | |
| FANRIND | Normal/Reference Range Indicator | text | 200 | |
| FARESCAT | Result Category | text | 200 | |
| FASTAT | Completion Status | text | 200 | |
| FAREASND | Reason Not Performed | text | 200 | |
| FAXFN | External File Path | text | 200 | |
| FANAM | Laboratory/Vendor Name | text | 200 | |
| FALOINC | LOINC Code | text | 200 | |
| FASPEC | Specimen Material Type | text | 200 | |
| FAANTREG | Anatomical Region | text | 200 | |
| FASPCCND | Specimen Condition | text | 200 | |
| FASPCUFL | Specimen Usability for the Test | text | 200 | |
| FALOC | Location of the Finding About | text | 200 | |
| FALAT | Laterality of Location of Finding About | text | 200 | |
| FADIR | Directionality | text | 200 | |
| FAPORTOT | Portion or Totality | text | 200 | |
| FARUNID | Run ID | text | 200 | |
| FAANMETH | Analysis Method | text | 200 | |
| FAMETHOD | Method of Test or Examination | text | 200 | |
| FALEAD | Lead Identified to Collect Measurements | text | 200 | |
| FACSTATE | Consciousness State | text | 200 | |
| FABLFL | Baseline Flag | text | 200 | |
| FAFAST | Fasting Status | text | 200 | |
| FADRVFL | Derived Flag | text | 200 | |
| FAEVAL | Evaluator | text | 200 | |
| FAEVALID | Evaluator Identifier | text | 200 | |
| FAACPTFL | Accepted Record Flag | text | 200 | |
| FATOX | Toxicity | text | 200 | |
| FATOXGR | Toxicity Grade | text | 200 | |
| FASEV | Severity | text | 200 | |
| FADTHREL | Relationship to Death | text | 200 | |
| FALLOQ | Lower Limit of Quantitation | float | 200 | |
| FAULOQ | Upper Limit of Quantitation | float | 200 | |
| FAEXCLFL | Exclude from Statistics | text | 200 | |
| FAREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| FADTC | Date/Time of Collection | datetime | 200 | |
| FASTDTC | Start Date/Time of Observation | datetime | 200 | |
| FAENDTC | End Date/Time of Observation | datetime | 200 | |
| FADY | Study Day of Collection | integer | 200 | |
| FASTDY | Study Day of Start of Observation | integer | 200 | |
| FAENDY | Study Day of End of Observation | integer | 200 | |
| FADUR | Duration | text | 200 | |
| FATPT | Planned Time Point Name | text | 200 | |
| FATPTNUM | Planned Time Point Number | float | 200 | |
| FAELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| FATPTREF | Time Point Reference | text | 200 | |
| FARFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| FASTRF | Start Relative to Reference Period | text | 200 | |
| FAENRF | End Relative to Reference Period | text | 200 | |
| FAEVLINT | Evaluation Interval | text | 200 | |
| FAEVINTX | Evaluation Interval Text | text | 200 | |
| FASTRTPT | Start Relative to Reference Time Point | text | 200 | |
| FASTTPT | Start Reference Time Point | text | 200 | |
| FAENRTPT | End Relative to Reference Time Point | text | 200 | |
| FAENTPT | End Reference Time Point | text | 200 | |
| FASTINT | Planned Start of Assessment Interval | datetime | 200 | |
| FAENINT | Planned End of Assessment Interval | datetime | 200 | |
| FADETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
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| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
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| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
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| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
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| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
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| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
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| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
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| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
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| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
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| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
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| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
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| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
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| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
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| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
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| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
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| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
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| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
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| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
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| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
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| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
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| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
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| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
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| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
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| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
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| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
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| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
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| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
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| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
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| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
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| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
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| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
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| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
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| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
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| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
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| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
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| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
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| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
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| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
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| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
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| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
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| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
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| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
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| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
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| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
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| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
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| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
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| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
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| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
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| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
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| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
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| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
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| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
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| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
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| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
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| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
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| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
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| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
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| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
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| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
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| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
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| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
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| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
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| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
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| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
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| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
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| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
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| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
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| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
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Findings About Events or Interventions
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TESTCD | Findings About Test Short Name |
|
text | 200 |
| __TEST | Findings About Test Name |
|
text | 200 |
| __OBJ | Object of the Observation |
|
text | 200 |
| __MODIFY | Modified Term | text | 200 | |
| __TSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| __CAT | Category for Findings About | text | 200 | |
| __SCAT | Subcategory for Findings About | text | 200 | |
| __POS | Position of Subject During Observation | text | 200 | |
| __BODSYS | Body System or Organ Class | text | 200 | |
| __ORRES | Result or Finding in Original Units | text | 200 | |
| __ORRESU | Original Units | text | 200 | |
| __ORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| __ORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| __STRESC | Character Result/Finding in Std Format | text | 200 | |
| __STRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| __STRESU | Standard Units | text | 200 | |
| __STNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| __STNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| __STNRC | Normal Range for Character Results | text | 200 | |
| __NRIND | Normal/Reference Range Indicator | text | 200 | |
| __RESCAT | Result Category | text | 200 | |
| __STAT | Completion Status | text | 200 | |
| __REASND | Reason Not Performed | text | 200 | |
| __XFN | External File Path | text | 200 | |
| __NAM | Laboratory/Vendor Name | text | 200 | |
| __LOINC | LOINC Code | text | 200 | |
| __SPEC | Specimen Material Type | text | 200 | |
| __ANTREG | Anatomical Region | text | 200 | |
| __SPCCND | Specimen Condition | text | 200 | |
| __SPCUFL | Specimen Usability for the Test | text | 200 | |
| __LOC | Location of the Finding About | text | 200 | |
| __LAT | Laterality of Location of Finding About | text | 200 | |
| __DIR | Directionality | text | 200 | |
| __PORTOT | Portion or Totality | text | 200 | |
| __RUNID | Run ID | text | 200 | |
| __ANMETH | Analysis Method | text | 200 | |
| __METHOD | Method of Test or Examination | text | 200 | |
| __LEAD | Lead Identified to Collect Measurements | text | 200 | |
| __CSTATE | Consciousness State | text | 200 | |
| __BLFL | Baseline Flag | text | 200 | |
| __FAST | Fasting Status | text | 200 | |
| __DRVFL | Derived Flag | text | 200 | |
| __EVAL | Evaluator | text | 200 | |
| __EVALID | Evaluator Identifier | text | 200 | |
| __ACPTFL | Accepted Record Flag | text | 200 | |
| __TOX | Toxicity | text | 200 | |
| __TOXGR | Toxicity Grade | text | 200 | |
| __SEV | Severity | text | 200 | |
| __DTHREL | Relationship to Death | text | 200 | |
| __LLOQ | Lower Limit of Quantitation | float | 200 | |
| __ULOQ | Upper Limit of Quantitation | float | 200 | |
| __EXCLFL | Exclude from Statistics | text | 200 | |
| __REASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| __DTC | Date/Time of Collection | datetime | 200 | |
| __STDTC | Start Date/Time of Observation | datetime | 200 | |
| __ENDTC | End Date/Time of Observation | datetime | 200 | |
| __DY | Study Day of Collection | integer | 200 | |
| __STDY | Study Day of Start of Observation | integer | 200 | |
| __ENDY | Study Day of End of Observation | integer | 200 | |
| __DUR | Duration | text | 200 | |
| __TPT | Planned Time Point Name | text | 200 | |
| __TPTNUM | Planned Time Point Number | float | 200 | |
| __ELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| __TPTREF | Time Point Reference | text | 200 | |
| __RFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| __STRF | Start Relative to Reference Period | text | 200 | |
| __ENRF | End Relative to Reference Period | text | 200 | |
| __EVLINT | Evaluation Interval | text | 200 | |
| __EVINTX | Evaluation Interval Text | text | 200 | |
| __STRTPT | Start Relative to Reference Time Point | text | 200 | |
| __STTPT | Start Reference Time Point | text | 200 | |
| __ENRTPT | End Relative to Reference Time Point | text | 200 | |
| __ENTPT | End Reference Time Point | text | 200 | |
| __STINT | Planned Start of Assessment Interval | datetime | 200 | |
| __ENINT | Planned End of Assessment Interval | datetime | 200 | |
| __DETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1380 | At least one of the following subject identifier variables must be populated for each record: Unique Subject Identifier (USUBJID), Associated Persons Identifier (APID), Sponsor Device Identifier (SPDEVID), or Pool Identifier (POOLID). | Condition | No subject identifier variables are populated |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Skin Response
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| SRSEQ | Sequence Number |
|
float | 200 |
| SRGRPID | Group ID | text | 200 | |
| SRREFID | Reference ID | text | 200 | |
| SRSPID | Sponsor-Defined Identifier | text | 200 | |
| SRLNKID | Link ID | text | 200 | |
| SRLNKGRP | Link Group ID | text | 200 | |
| SRTESTCD | Skin Response Test or Exam Short Name |
|
text | 200 |
| SRTEST | Skin Response Test or Examination Name |
|
text | 200 |
| SROBJ | Object of the Observation |
|
text | 200 |
| SRMODIFY | Modified Term | text | 200 | |
| SRTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| SRCAT | Category for Test | text | 200 | |
| SRSCAT | Subcategory for Test | text | 200 | |
| SRPOS | Position of Subject During Observation | text | 200 | |
| SRBODSYS | Body System or Organ Class | text | 200 | |
| SRORRES | Results or Findings in Original Units | text | 200 | |
| SRORRESU | Original Units | text | 200 | |
| SRORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| SRORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| SRSTRESC | Result or Finding in Standard Format | text | 200 | |
| SRSTRESN | Numeric Results/Findings in Std. Units | float | 200 | |
| SRSTRESU | Standard Units | text | 200 | |
| SRSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| SRSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| SRSTNRC | Normal Range for Character Results | text | 200 | |
| SRNRIND | Normal/Reference Range Indicator | text | 200 | |
| SRRESCAT | Result Category | text | 200 | |
| SRSTAT | Completion Status | text | 200 | |
| SRREASND | Reason Not Done | text | 200 | |
| SRXFN | External File Path | text | 200 | |
| SRNAM | Vendor Name | text | 200 | |
| SRLOINC | LOINC Code | text | 200 | |
| SRSPEC | Specimen Type | text | 200 | |
| SRANTREG | Anatomical Region | text | 200 | |
| SRSPCCND | Specimen Condition | text | 200 | |
| SRSPCUFL | Specimen Usability for the Test | text | 200 | |
| SRLOC | Location used for Measurement | text | 200 | |
| SRLAT | Laterality | text | 200 | |
| SRDIR | Directionality | text | 200 | |
| SRPORTOT | Portion or Totality | text | 200 | |
| SRMETHOD | Method of Test or Examination | text | 200 | |
| SRRUNID | Run ID | text | 200 | |
| SRANMETH | Analysis Method | text | 200 | |
| SRLEAD | Lead Identified to Collect Measurements | text | 200 | |
| SRCSTATE | Consciousness State | text | 200 | |
| SRBLFL | Baseline Flag | text | 200 | |
| SRFAST | Fasting Status | text | 200 | |
| SRDRVFL | Derived Flag | text | 200 | |
| SREVAL | Evaluator | text | 200 | |
| SREVALID | Evaluator Identifier | text | 200 | |
| SRACPTFL | Accepted Record Flag | text | 200 | |
| SRTOX | Toxicity | text | 200 | |
| SRTOXGR | Toxicity Grade | text | 200 | |
| SRSEV | Severity | text | 200 | |
| SRDTHREL | Relationship to Death | text | 200 | |
| SRLLOQ | Lower Limit of Quantitation | float | 200 | |
| SRULOQ | Upper Limit of Quantitation | float | 200 | |
| SREXCLFL | Exclude from Statistics | text | 200 | |
| SRREASEX | Reason for Exclusion from Statistics | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Visit | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SRDTC | Date/Time of Collection | datetime | 200 | |
| SRSTDTC | Start Date/Time of Observation | datetime | 200 | |
| SRENDTC | End Date/Time of Observation | datetime | 200 | |
| SRDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| SRSTDY | Study Day of Start of Observation | integer | 200 | |
| SRENDY | Study Day of End of Observation | integer | 200 | |
| SRDUR | Duration | text | 200 | |
| SRTPT | Planned Time Point Name | text | 200 | |
| SRTPTNUM | Planned Time Point Number | float | 200 | |
| SRELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| SRTPTREF | Time Point Reference | text | 200 | |
| SRRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| SRSTRF | Start Relative to Reference Period | text | 200 | |
| SRENRF | End Relative to Reference Period | text | 200 | |
| SREVLINT | Evaluation Interval | text | 200 | |
| SREVINTX | Evaluation Interval Text | text | 200 | |
| SRSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| SRSTTPT | Start Reference Time Point | text | 200 | |
| SRENRTPT | End Relative to Reference Time Point | text | 200 | |
| SRENTPT | End Reference Time Point | text | 200 | |
| SRSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| SRENINT | Planned End of Assessment Interval | datetime | 200 | |
| SRDETECT | Time in Days to Detection | integer | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0003 | Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0005 | The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain. Exclusions are DE, DO, DT, DU, and DX domains. | Unique | Duplicate value for %Domain%SEQ variable |
|
|
| SD0007 | Standard Units (--STRESU) must be consistent for all records with the same Short Name of Measurement, Test or Examination (--TESTCD), Object of the Observation (--OBJ), Measurement Test, or Examination Detail (--TSTDTL), Category (--CAT), Specimen Type (--SPEC), Method of Test or Examination (--METHOD), and Marker String (--MRKSTR). | Unique | Inconsistent value for Standard Units |
|
|
| SD0015 | Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0. | Regex | Negative value for %Domain%DUR |
|
|
| SD0016 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Derived Flag (--DRVFL) value is 'Y'. | Required | Missing value for %Domain%STRESC when %Domain%DRVFL='Y' |
|
|
| SD0017 | The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length. | Regex | Invalid value for %Domain%TEST variable |
|
|
| SD0018 | The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for %Domain%TESTCD variable |
|
|
| SD0023 | Completion Status (--STAT) should be set to 'NOT DONE' when Reason Not Done (--REASND) is populated. | Required | Missing value for %Domain%STAT when %Domain%REASND is provided |
|
|
| SD0024 | Date/Time of Collection (--DTC) should not be NULL when End Date/Time of Observation (--ENDTC) is not NULL. | Required | Missing value for %Domain%DTC when %Domain%ENDTC is provided |
|
|
| SD0025 | Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC). | Condition | %Domain%DTC is after %Domain%ENDTC |
|
|
| SD0026 | Original Units (--ORRESU) should not be NULL when Result or Finding in Original Units (--ORRES) is provided is a numeric result. | Required | Missing value for %Domain%ORRESU when %Domain%ORRES is provided |
|
|
| SD0027 | Result or Finding in Original Units (--ORRES) should not be NULL when Original Units (--ORRESU) is provided. | Required | Missing value for %Domain%ORRES when %Domain%ORRESU is provided |
|
|
| SD0028 | Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value. | Condition | Value for %Domain%STNRHI is less than value for %Domain%STNRLO |
|
|
| SD0029 | Standard Units (--STRESU) should not be NULL when Character Result/Finding in Std Units (--STRESC) is provided as a numeric result. | Required | Missing value for %Domain%STRESU when %Domain%STRESC is provided |
|
|
| SD0030 | Character Result/Finding in Std Units (--STRESC) should not be NULL when Standard Units (--STRESU) is provided. | Required | Missing value for %Domain%STRESC when %Domain%STRESU is provided |
|
|
| SD0032 | Planned Time Point Name (--TPT) should not be NULL when Planned Time Point Number (--TPTNUM) is populated. | Required | Missing value for %Domain%TPT when %Domain%TPTNUM is provided |
|
|
| SD0033 | Planned Time Point Number (--TPTNUM) should not be NULL when Planned Time Point Name (--TPT) is populated. | Required | Missing value for %Domain%TPTNUM when %Domain%TPT is provided |
|
|
| SD0034 | Time Point Reference (--TPTREF) should not be NULL when Planned Elapsed Time from Time Point Ref (--ELTM) is populated. | Required | Missing value for %Domain%TPTREF when %Domain%ELTM is provided |
|
|
| SD0036 | Character Result/Finding in Std Units (--STRESC) must be populated when Result or Finding in Original Units (--ORRES) is provided. | Required | Missing value for %Domain%STRESC when %Domain%ORRES is provided |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0038 | Study Day variables (*DY) value should not equal 0. | Regex | Value of %Variable% Study Day variable equals 0 |
|
|
| SD0040 | All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD). | Unique | Inconsistent value for %Domain%TEST within %Domain%TESTCD |
|
|
| SD0045 | Character Result/Finding in Std Units (--STRESC) should be provided when Result Category (--RESCAT) is specified. | Required | Missing value for %Domain%STRESC when %Domain%RESCAT is populated |
|
|
| SD0047 | Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y' when Result or Finding in Original Units (--ORRES) is NULL. | Condition | Missing value for %Domain%ORRES when %Domain%STAT or %Domain%DRVFL is not populated |
|
|
| SD0049 | Start Reference Time Point (--STTPT) must not be NULL when Start Relative to Reference Time Point (--STRTPT) is provided. | Required | Missing value for %Domain%STTPT when %Domain%STRTPT is populated |
|
|
| SD0050 | End Reference Time Point (--ENTPT) must not be NULL when End Relative to Reference Time Point (--ENRTPT) is provided. | Required | Missing value for %Domain%ENTPT when %Domain%ENRTPT is populated |
|
|
| SD0051 | All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM). | Unique | Inconsistent value for VISIT within VISITNUM |
|
|
| SD0052 | All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT). | Unique | Inconsistent value for VISITNUM within VISIT |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0065 | All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain. There is an exception for records, where Status (--STAT) variable value is populated. E.g., --STAT = 'NOT DONE'. Another exception is for records, where Occurrence (ECOCCUR) is 'N' in EC domain. | Lookup | USUBJID/VISIT/VISITNUM values do not match SV domain data |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1011 | Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard. | Regex | Invalid ISO 8601 value for %Variable% variable |
|
|
| SD1014 | Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TAETORD |
|
|
| SD1015 | Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid EPOCH |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1023 | Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain except for Unscheduled and Unplanned visits. | Lookup | VISIT/VISITNUM values do not match TV domain data |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1030 | Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC). | Lookup | Value for %Domain%STRF is populated when RFSTDTC is NULL |
|
|
| SD1031 | End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC). | Lookup | Value for %Domain%ENRF is populated when RFENDTC is NULL |
|
|
| SD1039 | Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%CAT value is redundant with other variable values |
|
|
| SD1040 | Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS). | Condition | %Domain%SCAT value is redundant with other variable values |
|
|
| SD1041 | Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical. | Condition | Values for %Domain%CAT and %Domain%SCAT are identical |
|
|
| SD1043 | All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST). | Unique | Inconsistent value for %Domain%TESTCD within %Domain%TEST |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1077 | Variables requested by the relevant regulatory agency in policy documents should be included in the dataset. E.g., EPOCH. | Find | Regulatory Expected variable %Variable% not found |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1083 | Collection Study Day (--DY) variable should be included into dataset when Collection Study Date/Time (--DTC) variable is present. | Find | Missing %Domain%DY variable when %Domain%DTC variable is present |
|
|
| SD1084 | Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%DY variable value is not populated |
|
|
| SD1085 | Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part. | Condition | %Domain%DY variable value is imputed |
|
|
| SD1086 | Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%DY variable |
|
|
| SD1087 | Study Day of Start (--STDY) variable should be included into dataset when Start Study Date/Time (--STDTC) variable is present. | Find | Missing %Domain%STDY variable when %Domain%STDTC variable is present |
|
|
| SD1088 | Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is not populated |
|
|
| SD1089 | Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%STDY variable value is imputed |
|
|
| SD1090 | Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%STDY variable |
|
|
| SD1091 | Study Day of End (--ENDY) variable should be included into dataset when End Study Date/Time (--ENDTC) variable is present. | Find | Missing %Domain%ENDY variable when %Domain%ENDTC variable is present |
|
|
| SD1092 | Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is not populated |
|
|
| SD1093 | Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part. | Condition | %Domain%ENDY variable value is imputed |
|
|
| SD1094 | Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC. | Condition | Incorrect value for %Domain%ENDY variable |
|
|
| SD1095 | Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain. | Find | Invalid dataset name for split domain |
|
|
| SD1098 | Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated. | Condition | Missing %Domain%CAT value when %Domain%SCAT value is populated |
|
|
| SD1099 | Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present. | Find | Missing %Domain%CAT variable when %Domain%SCAT variable is present |
|
|
| SD1101 | End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present. | Find | Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present |
|
|
| SD1102 | End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present. | Find | Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present |
|
|
| SD1103 | Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present. | Find | Missing %Domain%STTPT variable when %Domain%STRTPT variable is present |
|
|
| SD1104 | Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present. | Find | Missing %Domain%STRTPT variable when %Domain%STTPT variable is present |
|
|
| SD1116 | Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting. | Unique | Inconsistent variable length within split datasets |
|
|
| SD1117 | The structure of Findings class domains should be one record per Finding Result per subject. No Finding Result with the same Test Short Name (--TESTCD) and the same Qualifier variables at the same timepoint for the same Subject (USUBJID) are expected. | Unique | Duplicate records |
|
|
| SD1122 | Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Required | Missing value for %Domain%STRESN |
|
|
| SD1123 | Value of Original Result (--ORRES) variable is expected to be missing when observation was not performed (Status (--STAT) is 'NOT DONE'). | Condition | %Domain%ORRES value is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SD1125 | All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) and/or Visit Number (VISITNUM). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF and/or VISITNUM |
|
|
| SD1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%TPTREF, VISITNUM |
|
|
| SD1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable, Time Point Reference (--TPTREF) variable, and Visit Number (VISITNUM) variable. | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%TPTREF, VISITNUM |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| SD1137 | Character Result/Finding in Original Units (--ORRES) value should be NULL when Derived Flag (--DRVFL) value is 'Y'. | Condition | Non-missing value for %Domain%ORRES when %Domain%DRVFL='Y' |
|
|
| SD1138 | Derived Flag (--DRVFL) variable may be populated only when Result in Original Units (--ORRES) value is NULL and Result in Std. Format (--STRESC) value is populated (result is derived rather than collected). | Condition | %Domain%DRVFL='Y' when %Domain%ORRES value is populated |
|
|
| SD1149 | Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data has been collected for an Expected variable, however, a null column must still be included in the dataset, and a comment must be included in the define.xml to state that data was not collected. | Varlength | Expected variable with missing value for all records |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1202 | Start Date/Time (--STDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%STDTC date is after RFPENDTC |
|
|
| SD1203 | Date/Time of Collection (--DTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%DTC date is after RFPENDTC |
|
|
| SD1204 | End Date/Time (--ENDTC) variable value must be less than or equal to Date/Time of End of Participation (RFPENDTC). | Condition | %Domain%ENDTC date is after RFPENDTC |
|
|
| SD1212 | Standardized Result in Numeric Format (--STRESN) variable value should be equal Standardized Result in Character Format (--STRESC) variable value when Standardized Result in Character Format (--STRESC) variable value represents a numeric value. | Condition | %Domain%STRESN does not equal %Domain%STRESC |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1238 | --RFTDTC is defined as the Date/time for a fixed reference time point defined by --TPTREF, therefore --RFTDTC should only be populated when --TPTREF is populated. | Condition | %Domain%RFTDTC is populated when %Domain%TPTREF is not populated |
|
|
| SD1244 | Planned Time Point Name (--TPT) variable must be included into the domain when Planned Time Point Number (--TPTNUM) variable is present. | Find | Missing %Domain%TPT variable when %Domain%TPTNUM variable is present |
|
|
| SD1245 | Time Point Reference (--TPTREF) variable must be included into the domain when Date/Time of Reference Point (--RFTDTC) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%RFTDTC variable is present |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1250 | Planned Time Point Number (--TPTNUM) variable must be included into the domain when Planned Time Point Name (--TPT) variable is present. | Find | Missing %Domain%TPTNUM variable when %Domain%TPT variable is present |
|
|
| SD1272 | Test Code variables (--TESTCD) should not be populated with values of 'OTHER'. | Condition | %Domain%TESTCD equals 'OTHER' |
|
|
| SD1275 | Test Code variables (--TESTCD) should not be populated with values of 'MULTIPLE'. | Condition | %Domain%TESTCD equals 'MULTIPLE' |
|
|
| SD1280 | Toxicity (--TOX) variable should not be present in the domain when the Toxicity Grade (--TOXGR) variable is missing. | Find | %Domain%TOX variable is present when %Domain%TOXGR variable is missing |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1283 | Laterality (--LAT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%LAT variable is present when %Domain%LOC variable is missing |
|
|
| SD1284 | Portion or Totality (--PORTOT) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%PORTOT variable is present when %Domain%LOC variable is missing |
|
|
| SD1285 | Directionality (--DIR) variable should not be present in the domain when the Location (--LOC) variable is missing. | Find | %Domain%DIR variable is present when %Domain%LOC variable is missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1299 | All domains based on the general observation classes (Interventions, Events, Findings) should have at least one Timing variable present. | Find | No timing variables are present in dataset |
|
|
| SD1300 | The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains. | Regex | Invalid value for DOMAIN variable |
|
|
| SD1320 | Character Result/Finding in Std Format (--STRESC) value should not be NULL when Completion Status (--STAT) value is NULL. | Required | Missing value for %Domain%STRESC when %Domain%STAT is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1330 | Study Day of Observation (--DY) must be less or equal to Study Day of End of Observation (--ENDY). | Condition | %Domain%DY is after %Domain%ENDY |
|
|
| SD1339 | The EPOCH variable is not populated, however either a start date or a collection date is provided. The presence of a start date or collection date for a record should allow for the EPOCH variable to be populated. Variables requested by the relevant regulatory agency in policy documents (e.g., EPOCH) should be included in the dataset and populated. | Condition | Missing EPOCH value when a start or observation date is provided |
|
|
| SD1353 | Standardized Result in Character Format (--STRESC) variable value should be equal to Result or Finding in Original Units (--ORRES) variable value when variable values are numeric and Standard Units (--STRESU) and Original Units (--ORRESU) are populated with the same units or are null. | Condition | %Domain%STRESC does not equal %Domain%ORRES when %Domain%STRESU is equal to %Domain%ORRESU |
|
|
| SD1439 | By its definition clinical baseline flags (e.g., last non-missing value prior to first dose) should have only a single record for the same test for subject. Therefore, each subject (USUBJID) should have no more than one record with Baseline Flag (--BLFL) equals 'Y' for the same assessment which is defined by Test (--TESTCD), Test Details (--TSTDTL), Category (--CAT), Subcategory (--SCAT), Method (--METHOD), Specimen (--SPEC), Location (--LOC), Laterality (--LAT), Directionality (--DIR), Position (--POS) and Object (--OBJ) variables. | Unique | Multiple BASELINE records for the same test |
|
|
| SD1448 | Standardized Result in Numeric Format (--STRESN) variable value should be null when Standardized Result in Character Format (--STRESC) variable value does not represent a numeric value, (e.g., 'BLQ', value contains '<' or '>', etc.). | Condition | %Domain%STRESN is populated when %Domain%STRESC value is not numeric |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
|
| SD2239 | Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID), Visit Num (VISITNUM), Object (--OBJ) and Assessment Date/Time (--DTC). | Unique | Inconsistent value for %Domain%TPT |
|
|
| SD2270 | Collection Study Date/Time (--DTC) variable should be included into dataset when Collection Study Day (--DY) variable is present. | Find | Missing %Domain%DTC variable when %Domain%DY variable is present |
|
|
| SD2271 | Start Study Date/Time (--STDTC) variable should be included into dataset when Study Day of Start (--STDY) variable is present. | Find | Missing %Domain%STDTC variable when %Domain%STDY variable is present |
|
|
| SD2272 | End Study Date/Time (--ENDTC) variable should be included into dataset when Study Day of End (--ENDY) variable is present. | Find | Missing %Domain%ENDTC variable when %Domain%ENDY variable is present |
|
Associated Persons Related to Subjects
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| APID | Associated Persons Identifier |
|
text | 200 |
| RSUBJID | Related Subject or Pool Identifier | text | 200 | |
| RDEVID | Related Device Identifier | text | 200 | |
| SREL | Subject, Device, or Study Relationship |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1233 | All Medical Devices (SPDEVID) must be present in Device Identifier (DI) domain. | Lookup | Device is not present in DI domain |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1326 | Related Device Identifier (RDEVID) and Related Subject or Pool Identifier (RSUBJID) should not both be populated for the same record. | Condition | RDEVID is not null when RSUBJID is populated |
|
Pool Definition
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| POOLID | Pool Identifier |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0004 | Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset. | Match | Inconsistent value for DOMAIN |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1246 | Time Point Reference (--TPTREF) variable must be included into the domain when Planned Elapsed Time from Time Point Ref (--ELTM) variable is present. | Find | Missing %Domain%TPTREF variable when %Domain%ELTM variable is present |
|
|
| SD1282 | Time Point Reference (--TPTREF) variable should not be present in the domain when the Planned Elapsed Time from Time Point Ref (--ELTM) variable, Planned Time Point Number (--TPTNUM) variable, and Planned Time Point (--TPT) variable are missing. | Find | %Domain%TPTREF variable is present when %Domain%ELTM, %Domain%TPTNUM, and %Domain%TPT are missing |
|
|
| SD1291 | End Relative to Reference Time Point (--ENRTPT) must be populated when End Reference Time Point (--ENTPT) is populated. | Condition | Missing value for %Domain%ENRTPT when %Domain%ENTPT is populated |
|
|
| SD1292 | Start Relative to Reference Time Point (--STRTPT) must be populated when Start Reference Time Point (--STTPT) is populated. | Condition | Missing value for %Domain%STRTPT when %Domain%STTPT is populated |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
Related Records
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| RDOMAIN | Related Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| IDVAR | Identifying Variable |
|
text | 200 |
| IDVARVAL | Identifying Variable Value | text | 200 | |
| RELTYPE | Relationship Type | text | 200 | |
| RELID | Relationship Identifier |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0072 | Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data. | Metadata | Invalid RDOMAIN |
|
|
| SD0075 | Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain. | Metadata | Invalid IDVAR |
|
|
| SD0077 | Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain. | Lookup | Invalid referenced record |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1026 | Relationship Type (RELTYPE) must be NULL when Identifying Variable (IDVAR) is populated with a --SEQ value. | Condition | Invalid value for RELTYPE variable |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1066 | Variable Value (IDVARVAL) variable value should not be populated when Relationship Type (RELTYPE) variable value is populated. | Condition | IDVARVAL value is populated when RELTYPE values is populated |
|
|
| SD1067 | Unique Subject Identifier (USUBJID) variable value should not be populated when Relationship Type (RELTYPE) variable value is populated. | Condition | USUBJID value is populated when RELTYPE values is populated |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1072 | Value of Identifying Variable (IDVAR) variable must be populated when Related Domain Abbreviation (RDOMAIN) variable value is provided, with the only exception of 'DM' value for RDOMAIN. | Required | Missing IDVAR value when RDOMAIN value is provided |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1128 | Relationship Type (RELTYPE) variable values should be populated with terms 'ONE', 'MANY' when Related Records (RELREC) dataset is used to identify relationships between datasets. | Match | Invalid value for RELTYPE variable |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1264 | When the RELREC dataset is used to identify relationships between datasets (in which case USUBJID and IDVARVAL are left null), instead of relating individual records, --SEQ cannot be used for IDVAR because --SEQ only has meaning within a subject within a dataset, not across datasets. | Condition | IDVAR equals --SEQ when IDVARVAL is null and USUBJID is null |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
Related Subjects
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| RSUBJID | Related Subject or Pool Identifier | text | 200 | |
| SREL | Subject Relationship |
|
text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD1327 | The Related Subject or Pool Identifier (RSUBJID) value should not be equal to Pool Identifier (POOLID). | Condition | RSUBJID is equal to POOLID |
|
|
| SD1328 | The Related Subject or Pool Identifier (RSUBJID) value should not be equal to USUBJID. | Condition | RSUBJID is equal to USUBJID |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|
Supplemental Qualifiers
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| RDOMAIN | Related Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| IDVAR | Identifying Variable | text | 200 | |
| IDVARVAL | Identifying Variable Value | text | 200 | |
| QNAM | Qualifier Variable Name |
|
text | 200 |
| QLABEL | Qualifier Variable Label |
|
text | 200 |
| QVAL | Data Value |
|
text | 200 |
| QORIG | Origin |
|
text | 200 |
| QEVAL | Evaluator | text | 200 |
| ID | Description | Validator | Message | Severity | Active |
|---|---|---|---|---|---|
| CT2001 | Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist |
|
|
| CT2002 | Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist |
|
|
| CT2003 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT |
|
|
| CT2004 | Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2005 | Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. | Match | %Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression% |
|
|
| CT2006 | Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition. | Match | %Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression% |
|
|
| SD0001 | Domain table should have at least one record. | Property | No records in data source |
|
|
| SD0002 | Required variables (where Core attribute is 'Req') cannot be NULL for any records. | Required | NULL value in %Variable% variable marked as Required |
|
|
| SD0037 | Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml. | Match | Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist |
|
|
| SD0046 | All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM). | Unique | Inconsistent value for QLABEL within QNAM |
|
|
| SD0054 | Variables listed in the data definition document (define.xml) should be included in the dataset. | Find | Variable in define.xml is not present in the dataset |
|
|
| SD0055 | Variable Data Types in the dataset should match the variable data types described in SDTM. | Match | SDTM/dataset variable type mismatch |
|
|
| SD0056 | Variables described in SDTM IG as Required must be included in the dataset. | Find | SDTM Required variable %Variable% not found |
|
|
| SD0057 | Variables described in SDTM IG as Expected should be included in the dataset. | Find | SDTM Expected variable %Variable% not found |
|
|
| SD0058 | Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified. | Match | Variable appears in dataset, but is not in SDTM model |
|
|
| SD0059 | Variable DataType in define.xml must match variable Type in dataset. Define-XML data types of 'integer' and 'float' match dataset type of 'Num', all other match 'Char'. | Condition | Define.xml/dataset variable type mismatch |
|
|
| SD0060 | Variables included in the dataset must be described in the data definition document (define.xml). | Match | Variable in dataset is not present in define.xml |
|
|
| SD0062 | Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited). | Property | Incompatible data source |
|
|
| SD0063 | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0063A | Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted. | Match | SDTM/dataset variable label mismatch |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| SD0072 | Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data. | Metadata | Invalid RDOMAIN |
|
|
| SD0075 | Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain. | Metadata | Invalid IDVAR |
|
|
| SD0077 | Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain. | Lookup | Invalid referenced record |
|
|
| SD0086 | All SUPPQUAL Domains records are associated with a single parent record and must have a unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variable value. For all SUPPQUAL domain record all The QNAM variable should be unique for each parent record. | Unique | SUPPQUAL duplicate records |
|
|
| SD0095 | Supplemental Qualifiers special purpose dataset (SUPP--) can only be used to capture non-standard variables and their association to parent records in general-observation-class datasets (Events, Findings, Interventions) and Demographics. Another exception is Subject Visits domain in SDTM-IG prior v3.4. | Condition | Invalid usage of SUPPQUAL for non-general-observation-class Domain |
|
|
| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
|
|
| SD1021 | Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables. | Regex | Unexpected character value in %Variable% variable |
|
|
| SD1022 | The value of Qualifier Variable Name (QNAM) should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. | Regex | Invalid value for QNAM variable |
|
|
| SD1029 | Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). | Regex | Non-ASCII or non-printable characters in %Variable% variable |
|
|
| SD1049 | Qualifier Variable Label (QLABEL) value may have up to 40 characters. | Regex | Invalid value for QLABEL |
|
|
| SD1051 | Both Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) should not be populated when relating information to the Demographics (DM) domain. | Condition | Unexpected value for IDVAR/IDVARVAL |
|
|
| SD1063 | Datasets included in study data must be described in the data definition document (define.xml). | Match | Dataset is not present in define.xml |
|
|
| SD1071 | Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB. | Property | Dataset is greater than 5 GB in size |
|
|
| SD1072 | Value of Identifying Variable (IDVAR) variable must be populated when Related Domain Abbreviation (RDOMAIN) variable value is provided, with the only exception of 'DM' value for RDOMAIN. | Required | Missing IDVAR value when RDOMAIN value is provided |
|
|
| SD1073 | Variables described in IG as inappropriate for usage must be not included in the dataset. | Find | Variable prohibited for use in SDTM |
|
|
| SD1074 | Variables designed only for SEND pre-clinical studies must be not included in the SDTM dataset. | Find | Variable which can be used only in SEND |
|
|
| SD1075 | Variables described in IG as not recommended for usage should be not included in the dataset. | Find | Variable not recommended for use |
|
|
| SD1076 | SDTM model variable may be added into standard domains according to its domain general class, if there are no restrictions on their usage specified in IG. | Find | Model permissible variable added into standard domain |
|
|
| SD1078 | Permissible variable should not be present in domain when the variable has missing value for all records in the dataset. | Varlength | Permissible variable with missing value for all records |
|
|
| SD1079 | The order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5. | Varorder | Variable is in wrong order within domain |
|
|
| SD1082 | Variable length should be assigned based on actual stored data to minimize file size. Datasets should be re-sized to the maximum length of actual data used prior to splitting. | Varlength | Variable length is too long for actual data |
|
|
| SD1120 | Comments should be stored in Comments (CO) domain, rather than be put into Supplemental Qualifier (SUPP--) domains. | Condition | Comments in %Domain% domain |
|
|
| SD1130 | All values of Qualifier Variable Name (QNAM) should be the same for a given value of Qualifier Variable Label (QLABEL). | Unique | Inconsistent value for QNAM within QLABEL |
|
|
| SD1152 | The structure of study data should be one record per unique combination of values in Key Variables provided in Define.xml file by KeySequence attribute for each domain or dataset. Note that Key Variables should represent physical structure of collected data. Utilization of artificial surrogate keys like --SEQ variable should be avoided. Current implementation of the rule is limited to the domain and does not use additional non-standard variables stored in SUPPQUAL datasets. | Unique | Duplicate records per Key Variables in Define.xml |
|
|
| SD1228 | Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file. | Match | %Variable% value not found in user-defined codelist '%Variable.@Clause.CodeList.Name%' when %Variable.@Clause.Expression% |
|
|
| SD1229 | Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file. | Required | %Variable% value is null when %Variable.@Clause.Expression% |
|
|
| SD1230 | Value level datatype must match the datatype described in define.xml. | Condition | %Variable% datatype is not %Variable.@Clause.DataType% when %Variable.@Clause.Expression% |
|
|
| SD1231 | Value level length must not exceed the length as specified define.xml. | Condition | %Variable% value is longer than defined max length %Variable.@Clause.Length% when %Variable.@Clause.Expression% |
|
|
| SD1265 | For subjective data (when QORIG='ASSIGNED'), QEVAL should be populated, and the value should reflect the role of the person or institution assigning the value. | Condition | QEVAL is null when QORIG equals 'ASSIGNED' |
|
|
| SD1324 | Variable Label in define.xml must match variable Label in dataset. | Match | Define.xml/dataset variable label mismatch |
|
|
| SD1325 | Dataset Description in define.xml must match dataset Description. | Property | Define.xml/dataset description mismatch |
|
|
| SD2006 | MedDRA coding info should be populated using variables in the Events General Observation Class, but not in SUPPQUAL domains. | Condition | Unexpected MedDRA coding in the SUPPQUAL domain |
|
|
| SD2024 | Only one of the Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values may be populated, not both. | Condition | Redundant values for USUBJID and POOLID |
|