Validator Configuration
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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| 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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| SE0007 | Trial Sets (TX) dataset should be included in every submission. | Find | Missing TX dataset |
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| SE1155 | Procedure Agents (AG) dataset should be included in every Animal Rule study submission. | Find | Missing AG dataset |
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| SE1156 | Challenge Agent Characterization (AC) dataset should be included in every Animal Rule study submission. | Find | Missing AC dataset |
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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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Challenge Agent Characterization
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| ACSEQ | Sequence Number |
|
float | 200 |
| ACGRPID | Group ID | text | 200 | |
| ACPARMCD | Challenge Agent Parameter Short Name |
|
text | 200 |
| ACPARM | Challenge Agent Parameter |
|
text | 200 |
| ACVAL | Parameter Value | text | 200 | |
| ACVAL1 | Parameter Value 1 | text | 200 | |
| ACVAL2 | Parameter Value 2 | text | 200 | |
| ACVAL3 | Parameter Value 3 | text | 200 | |
| ACVAL4 | Parameter Value 4 | text | 200 | |
| ACVAL5 | Parameter Value 5 | text | 200 | |
| ACVAL6 | Parameter Value 6 | text | 200 | |
| ACVAL7 | Parameter Value 7 | text | 200 | |
| ACVAL8 | Parameter Value 8 | text | 200 | |
| ACVAL9 | Parameter Value 9 | text | 200 | |
| ACVAL10 | Parameter Value 10 | text | 200 | |
| ACVALU | Parameter Units | text | 200 | |
| ACVALNF | Parameter Null Flavor | text | 200 | |
| ACVALCD | Parameter Value Code | text | 200 | |
| ACVCDREF | Name of the Reference Terminology | text | 200 | |
| ACVCDVER | 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 |
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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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| SD0019 | The value of Parameter (--PARM) variable should be no more than 40 characters in length. | Regex | Invalid value for %Domain%PARM variable |
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| 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 |
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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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| 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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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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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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| 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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| 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 |
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| 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 |
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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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| 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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| 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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| 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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| SD1406 | 'Challenge Agent Category' (CAGTCAT) record must be populated in Challenge Agent Characterization (AC) domain. | Find | Missing CAGTCAT Challenge Agent Parameter |
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| SD1407 | 'Challenge Agent Supplier Address' (CAGTSUPA) record must be populated in Challenge Agent Characterization (AC) domain. | Find | Missing CAGTSUPA Challenge Agent Parameter |
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| SD1408 | 'Challenge Agent Supplier Name' (CAGTSUPN) record must be populated in Challenge Agent Characterization (AC) domain. | Find | Missing CAGTSUPN Challenge Agent Parameter |
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| SD1409 | 'Multiple Challenge Agent Category Ind' (MCCATIND) record must be populated in Challenge Agent Characterization (AC) domain. | Find | Missing MCCATIND Challenge Agent Parameter |
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| SD1410 | 'Multiple Challenge Agent Same Cat Ind' (MCSCTIND) record must be populated in Challenge Agent Characterization (AC) domain. | Find | Missing MCSCTIND Challenge Agent Parameter |
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| SD1411 | 'Biological Agent Material Ident Code' (BAMTIDCD) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BAMTIDCD Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1412 | 'Bio Ag Work Bank/Primary Stock Char Ind' (BWBPSIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BWBPSIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1413 | 'Biological Agent Biovar Name' (BABIOVRN) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BABIOVRN Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1414 | 'Biological Agent Category' (BACAT) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BACAT Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1415 | 'Biological Agent CoA Indicator' (BACOAIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BACOAIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1416 | 'Biological Agent Engineered Indicator' (BAENGIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BAENGIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1417 | 'Biological Agent Genus and Species' (BAGENSPC) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BAGENSPC Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1418 | 'Bio Master Bank or Seed Stock Dir Supp' (BAMBSSDS) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BAMBSSDS Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1419 | 'Biological Agent Nucleotide Sequence Ind' (BANSIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BANSIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1420 | 'Biological Agent Nucleotide Sequence Loc' (BANSLOC) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BANSLOC Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1421 | 'Biological Agent Serovar Name' (BASEROVN) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BASEROVN Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1422 | 'Biological Agent Strain Name' (BASTRNN) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'BIOLOGICAL'. | Find | Missing BASTRNN Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'BIOLOGICAL' |
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| SD1423 | 'Chemical Ag Metabolite Causes Injury Ind' (CHAMCIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'CHEMICAL'. | Find | Missing CHAMCIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'CHEMICAL' |
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| SD1424 | 'Chemical Agent CAS Number' (CHAGCAS) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'CHEMICAL'. | Find | Missing CHAGCAS Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'CHEMICAL' |
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| SD1425 | 'Chemical Agent Name' (CHAGNAM) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'CHEMICAL'. | Find | Missing CHAGNAM Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'CHEMICAL' |
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| SD1426 | 'Chemical Agent CoA Indicator' (CHCOAIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'CHEMICAL'. | Find | Missing CHCOAIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'CHEMICAL' |
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| SD1427 | 'Chemical Agent Material Ident Code' (CHMTIDCD) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'CHEMICAL'. | Find | Missing CHMTIDCD Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'CHEMICAL' |
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| SD1428 | 'Rad/Nuc Agent Ionizing Radiation Type' (RNAIOTYP) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNAIOTYP Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1429 | 'Rad/Nuc Agent Irrad Source Beam Strength' (RNAISBS) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNAISBS Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1430 | 'Rad/Nuc Agent Mixed Field Indicator' (RNAMFIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNAMFIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1431 | 'Rad/Nuc Agent Radioisotope Species Name' (RNARADSN) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNARADSN Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1432 | 'Rad/Nuc Agent Source' (RNASRC) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNASRC Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1433 | 'Body Irradiation Model' (BIRRMDL) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing BIRRMDL Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1434 | 'Percent Bone Marrow Not Irradiated' (PCTBMNIR) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing PCTBMNIR Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1435 | 'Rad/Nuc Targeted Injury Model' (RNTINJRM) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing RNTINJRM Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1436 | 'Exp Onset of Rad/Nuc Targeted Injury' (EORNINJR) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing EORNINJR Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1437 | 'Combined Injury (Rad and Non-Rad) Ind' (CIRNRIND) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing CIRNRIND Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| SD1438 | 'Irradiation Field Orientation/Sequence' (IRORSEQ) record is expected in the Challenge Agent Characterization (AC) domain when the Parameter Value (ACVAL) for the 'Challenge Agent Category' (CAGTCAT) parameter is 'RADIOLOGICAL/NUCLEAR'. | Find | Missing IRORSEQ Challenge Agent Parameter when ACPARMCD = 'CAGTCAT' and ACVAL = 'RADIOLOGICAL/NUCLEAR' |
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| 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 |
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| 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 |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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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 | 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 | Trial 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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| 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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| 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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| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
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 Identifier | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD2019 | Age Range (AGETXT) variable values should be populated with 'number-number' format. | Regex | Invalid value for AGETXT |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2201 | 'Age' (AGE) or 'Age Text' (AGETXT) records should be populated in Trial Summary (TS) domain. | Find | Missing both AGE and AGETXT Trial Summary Parameters |
|
|
| SE2202 | 'Age Unit' (AGEU) record should be populated in Trial Summary (TS) domain. | Find | Missing AGEU Trial Summary Parameter |
|
|
| SE2203 | 'Study Design' (SDESIGN) record should be populated in Trial Summary (TS) domain. | Find | Missing SDESIGN Trial Summary Parameter |
|
|
| SE2204 | 'Dosing Duration' (DOSDUR) record should be populated in Trial Summary (TS) domain. | Find | Missing DOSDUR Trial Summary Parameter |
|
|
| SE2205 | 'Experimental End Date' (EXPENDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing EXPENDTC Trial Summary Parameter |
|
|
| SE2206 | 'Experimental Start Date' (EXPSTDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing EXPSTDTC Trial Summary Parameter |
|
|
| SE2207 | 'Good Laboratory Practice Type' (GLPTYP) record should be populated in Trial Summary (TS) domain. | Find | Missing GLPTYP Trial Summary Parameter |
|
|
| SE2208 | 'Route of Administration' (ROUTE) record should be populated in Trial Summary (TS) domain. | Find | Missing ROUTE Trial Summary Parameter |
|
|
| SE2209 | 'SEND Implementation Guide Version' (SNDIGVER) record should be populated in Trial Summary (TS) domain. | Find | Missing SNDIGVER Trial Summary Parameter |
|
|
| SE2210 | 'SEND Control Terminology Version' (SNDCTVER) record should be populated in Trial Summary (TS) domain. | Find | Missing SNDCTVER Trial Summary Parameter |
|
|
| SE2211 | 'Species' (SPECIES) record should be populated in Trial Summary (TS) domain. | Find | Missing SPECIES Trial Summary Parameter |
|
|
| SE2212 | 'Test Subject Supplier' (SPLRNAM) record should be populated in Trial Summary (TS) domain. | Find | Missing SPLRNAM Trial Summary Parameter |
|
|
| SE2213 | 'Sponsor's Reference ID' (SPREFID) record should be populated in Trial Summary (TS) domain. | Find | Missing SPREFID Trial Summary Parameter |
|
|
| SE2214 | 'Sponsoring Organization' (SSPONSOR) record should be populated in Trial Summary (TS) domain. | Find | Missing SSPONSOR Trial Summary Parameter |
|
|
| SE2215 | 'Study Category' (STCAT) record should be populated in Trial Summary (TS) domain. | Find | Missing STCAT Trial Summary Parameter |
|
|
| SE2216 | 'Study Director' (STDIR) record should be populated in Trial Summary (TS) domain. | Find | Missing STDIR Trial Summary Parameter |
|
|
| SE2217 | 'Strain/Substrain' (STRAIN) record should be populated in Trial Summary (TS) domain. | Find | Missing STRAIN Trial Summary Parameter |
|
|
| SE2218 | 'Study Start Date' (STSTDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing STSTDTC Trial Summary Parameter |
|
|
| SE2219 | 'Study Title' (STITLE) record should be populated in Trial Summary (TS) domain. | Find | Missing STITLE Trial Summary Parameter |
|
|
| SE2220 | 'Study Type' (SSTYP) record should be populated in Trial Summary (TS) domain. | Find | Missing SSTYP Trial Summary Parameter |
|
|
| SE2221 | 'Investigational Therapy or Treatment' (TRT) record should be populated in Trial Summary (TS) domain. | Find | Missing TRT Trial Summary Parameter |
|
|
| SE2222 | 'Test Facility Country' (TFCNTRY) record should be populated in Trial Summary (TS) domain. | Find | Missing TFCNTRY Trial Summary Parameter |
|
|
| SE2223 | 'Test Facility Location' (TSTFLOC) record should be populated in Trial Summary (TS) domain. | Find | Missing TSTFLOC Trial Summary Parameter |
|
|
| SE2224 | 'Test Facility Name' (TSTFNAM) record should be populated in Trial Summary (TS) domain. | Find | Missing TSTFNAM Trial Summary Parameter |
|
|
| SE2225 | 'Time to Terminal Sacrifice' (TRMSAC) record should be populated in Trial Summary (TS) domain. | Find | Missing TRMSAC Trial Summary Parameter |
|
|
| SE2226 | 'Primary Treatment CAS Registry Number' (TRTCAS) record should be populated in Trial Summary (TS) domain. | Find | Missing TRTCAS Trial Summary Parameter |
|
|
| SE2227 | 'Treatment Vehicle' (TRTV) record should be populated in Trial Summary (TS) domain. | Find | Missing TRTV Trial Summary Parameter |
|
|
| SE2235 | Trial Summary (TS) domain must contain only one record for the 'SNDIGVER' parameter. | Unique | Multiple SNDIGVER records |
|
|
| SE2236 | Trial Summary (TS) domain must contain only one record for the 'SNDCTVER' parameter. | Unique | Multiple SNDCTVER records |
|
|
| SE2237 | Values from the Null Flavor Reason (NULLFLAV) codelist should be populated in Parameter Null Flavor (TSVALNF) rather than Parameter Value (TSVAL) in the Trial Summary (TS) domain when using SENDIG v3.1 and later. | Condition | Value from NULLFLAV codelist is populated in TSVAL |
|
|
| SE2238 | Values from the No Yes Response (NY) codelist should not be populated in Parameter Value (TSVAL) when TSPARMCD = 'GLPTYP' (Good Laboratory Practice Type) in the Trial Summary (TS) domain. The NY codelist should be used to populate TSVAL when TSPARMCD = 'GLPFL' (GLP Flag) and not when TSPARMCD = 'GLPTYP'. | Condition | Value from NY codelist is populated in TSVAL when TSPARMCD = 'GLPTYP' |
|
|
| SE2245 | 'Test Site Name' (TSNAM) record should be provided in the Trial Summary (TS) domain when records for 'Test Site Country' (TSCNTRY) and/or 'Test Site Location' (TSLOC) are present. | Find | Missing TSNAM Trial Summary Parameter when TSCNTRY and/or TSLOC Parameters are provided |
|
|
| SE2267 | 'Study Report Status' (STRPSTAT) record should be populated in Trial Summary (TS) domain. | Find | Missing STRPSTAT Trial Summary Parameter |
|
|
| SE2272 | Trial Summary (TS) domain must contain only one record for the 'SDESIGN' parameter. | Unique | Multiple SDESIGN records |
|
|
| SE2273 | Trial Summary (TS) domain must contain only one record for the 'STCAT' parameter. | Unique | Multiple STCAT records |
|
|
| SE2274 | Trial Summary (TS) domain must contain only one record for the 'SSTYP' parameter. | Unique | Multiple SSTYP records |
|
|
| SE2275 | Trial Summary (TS) domain must contain only one record for the 'STDIR' parameter. | Unique | Multiple STDIR records |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2320 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='SLENGTH'. | Regex | Invalid %Domain%VAL value for SLENGTH |
|
|
| SE2322 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'SPLANSUB'. | Condition | Invalid %Domain%VAL value for SPLANSUB |
|
|
| SE2323 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'PLANFSUB'. | Condition | Invalid %Domain%VAL value for PLANFSUB |
|
|
| SE2324 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'PLANMSUB'. | Condition | Invalid %Domain%VAL value for PLANMSUB |
|
|
| SE2325 | TSVAL variable value must be in ISO 8601 format when TSPARMCD='STSTDTC'. | Condition | Invalid TSVAL value for STSTDTC |
|
|
| SE2325A | TSVAL variable value must be in ISO 8601 format and include at least full date, when TSPARMCD='STSTDTC'. | Condition | Incomplete date for study start date |
|
|
| SE2326 | TSVAL variable value must be in ISO 8601 format when TSPARMCD='STENDTC'. | Condition | Invalid TSVAL value for STENDTC |
|
|
| SE2327 | 'Planned Number of Subjects' (SPLANSUB) record should be populated in Trial Summary (TS) domain. It is used for Janus Non Clinical data load blocking. | Find | Missing SPLANSUB Trial Summary Parameter |
|
|
| SE2328 | 'Study End Date' (STENDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing STENDTC Trial Summary Parameter |
|
|
| SE2329 | 'End Date/Time of Dose Interval' (DOSENDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing DOSENDTC Trial Summary Parameter |
|
|
| SE2330 | 'Start Date/Time of Dose Interval' (DOSSTDTC) record should be populated in Trial Summary (TS) domain. | Find | Missing DOSSTDTC Trial Summary Parameter |
|
|
| SE2331 | 'Good Laboratory Practice Flag' (GLPFL) record should be populated in Trial Summary (TS) domain. | Find | Missing GLPFL Trial Summary Parameter |
|
|
| SE2332 | 'Pharmacologic Class' (PCLASS) record should be populated in Trial Summary (TS) domain. | Find | Missing PCLASS Trial Summary Parameter |
|
|
| SE2333 | 'Planned Dose Frequency' (PDOSFRQ) record should be populated in Trial Summary (TS) domain. | Find | Missing PDOSFRQ Trial Summary Parameter |
|
|
| SE2334 | 'Sex of Participants' (SEXPOP) record must be populated in Trial Summary (TS) domain. | Find | Missing SEXPOP Trial Summary Parameter |
|
|
| SE2335 | 'Primary Treatment Unique Ingredient ID' (TRTUNII) record must be populated in Trial Summary (TS) domain. | Find | Missing TRTUNII Trial Summary Parameter |
|
|
| SE2336 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD='DOSENDTC'. | Condition | Invalid %Domain%VAL value for DOSENDTC |
|
|
| SE2337 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD='DOSSTDTC'. | Condition | Invalid %Domain%VAL value for DOSSTDTC |
|
|
| SE2338 | TSVAL for SNDIGVER record must be a valid term from (SNDIGVER) CT codelist. | Match | Invalid TSVAL value for SNDIGVER |
|
|
| SE2340 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD = 'EXPSTDTC'. | Condition | Invalid %Domain%VAL value for EXPSTDTC |
|
|
| SE2341 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD = 'EXPENDTC'. | Condition | Invalid %Domain%VAL value for EXPENDTC |
|
|
| SE2342 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='DOSDUR'. | Regex | Invalid %Domain%VAL value for DOSDUR |
|
|
| SE2343 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='INTSAC'. | Regex | Invalid %Domain%VAL value for INTSAC |
|
|
| SE2344 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='TRMSAC'. | Regex | Invalid %Domain%VAL value for TRMSAC |
|
|
| SE2345 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='RECSAC'. | Regex | Invalid %Domain%VAL value for RECSAC |
|
|
| SE2346 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'AGE'. | Condition | Invalid %Domain%VAL value for AGE |
|
|
| SE2355 | --VAL for ENVTEMPU record is the unit for the environmental temperature. Only values of 'C' or 'F' are acceptable. | Match | Invalid %Domain%VAL value for ENVTEMPU |
|
Trial Sets
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| SETCD | Set Code |
|
text | 200 |
| SET | Set Description |
|
text | 200 |
| TXSEQ | Sequence Number |
|
float | 200 |
| TXPARMCD | Trial Set Parameter Short Name |
|
text | 200 |
| TXPARM | Trial Set Parameter |
|
text | 200 |
| TXVAL | Trial Set Parameter Value |
|
text | 200 |
| TXVAL1 | Trial Set Parameter Value 1 | text | 200 | |
| TXVAL2 | Trial Set Parameter Value 2 | text | 200 | |
| TXVAL3 | Trial Set Parameter Value 3 | text | 200 | |
| TXVAL4 | Trial Set Parameter Value 4 | text | 200 | |
| TXVAL5 | Trial Set Parameter Value 5 | text | 200 | |
| TXVAL6 | Trial Set Parameter Value 6 | text | 200 | |
| TXVAL7 | Trial Set Parameter Value 7 | text | 200 | |
| TXVAL8 | Trial Set Parameter Value 8 | text | 200 | |
| TXVAL9 | Trial Set Parameter Value 9 | text | 200 | |
| TXVAL10 | Trial Set Parameter Value 10 | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1153 | 'Planned Number of Male Subjects' (PLANMSUB) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing PLANMSUB Trial Set Parameter within SETCD |
|
|
| SE1154 | 'Planned Number of Female Subjects' (PLANFSUB) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing PLANFSUB Trial Set Parameter within SETCD |
|
|
| SE2230 | All values of Set Description (SET) should be the same for a given value of Set Code (SETCD). | Unique | Inconsistent value for SET within SETCD |
|
|
| SE2231 | All values of Set Code (SETCD) should be the same for a given value of Set Description (SET). | Unique | Inconsistent value for SETCD within SET |
|
|
| SE2232 | Planned Arm Code (ARMCD) values in TXVAL (TXPARMCD = 'ARMCD') should match entries in the Trial Arms (TA) dataset. | Lookup | Invalid TXVAL for ARMCD |
|
|
| SE2300 | 'Arm Code' (ARMCD) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing ARMCD Trial Set Parameter within SETCD |
|
|
| SE2301 | 'Sponsor-Defined Group Code' (SPGRPCD) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing SPGRPCD Trial Set Parameter within SETCD |
|
|
| SE2302 | 'Group Label' (GRPLBL) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing GRPLBL Trial Set Parameter within SETCD |
|
|
| SE2303 | 'Dose Level' (TRTDOS) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing TRTDOS Trial Set Parameter within SETCD |
|
|
| SE2304 | 'Dose Units' (TRTDOSU) records should be populated for each SETCD in Trial Sets (TX) domain. | Find | Missing TRTDOSU Trial Set Parameter within SETCD |
|
|
| SE2316 | 'Control Type' (TCNTRL) record should be populated in Trial Sets (TX) domain. (There must be a record with TXPARMCD = TCNTRL within a set if the study has a control). | Find | No Trial Set with TCNTRL Parameter |
|
|
| SE2317 | The value of Parameter Code (TXPARMCD) variable must be unique for each Trial Set (SETCD) within the Trial Sets (TX) domain. | Unique | Duplicate TXPARMCD within a SETCD |
|
|
| SE2320 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='SLENGTH'. | Regex | Invalid %Domain%VAL value for SLENGTH |
|
|
| SE2322 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'SPLANSUB'. | Condition | Invalid %Domain%VAL value for SPLANSUB |
|
|
| SE2323 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'PLANFSUB'. | Condition | Invalid %Domain%VAL value for PLANFSUB |
|
|
| SE2324 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'PLANMSUB'. | Condition | Invalid %Domain%VAL value for PLANMSUB |
|
|
| SE2336 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD='DOSENDTC'. | Condition | Invalid %Domain%VAL value for DOSENDTC |
|
|
| SE2337 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD='DOSSTDTC'. | Condition | Invalid %Domain%VAL value for DOSSTDTC |
|
|
| SE2340 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD = 'EXPSTDTC'. | Condition | Invalid %Domain%VAL value for EXPSTDTC |
|
|
| SE2341 | TSVAL/TXVAL variable value must be in ISO 8601 format when TSPARMCD/TXPARMCD = 'EXPENDTC'. | Condition | Invalid %Domain%VAL value for EXPENDTC |
|
|
| SE2342 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='DOSDUR'. | Regex | Invalid %Domain%VAL value for DOSDUR |
|
|
| SE2343 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='INTSAC'. | Regex | Invalid %Domain%VAL value for INTSAC |
|
|
| SE2344 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='TRMSAC'. | Regex | Invalid %Domain%VAL value for TRMSAC |
|
|
| SE2345 | TSVAL/TXVAL value must be either ISO 8601 format for time period (e.g., P80Y) or null when TSPARMCD/TXPARMCD='RECSAC'. | Regex | Invalid %Domain%VAL value for RECSAC |
|
|
| SE2346 | TSVAL/TXVAL must be numeric when TSPARMCD/TXPARMCD = 'AGE'. | Condition | Invalid %Domain%VAL value for AGE |
|
|
| SE2347 | Set Code (SETCD) values defined in Trial Sets (TX) should be assigned to at least one subject (USUBJID) in Demographics (DM). | Lookup | SETCD value does not present in DM |
|
|
| SE2348 | Sequence Number (TXSEQ) should be unique within the entire Trial Sets (TX) dataset because there is no Unique Subject Identifier (USUBJID) variable. | Unique | Non-unique value for TXSEQ variable within TX domain |
|
|
| SE2355 | --VAL for ENVTEMPU record is the unit for the environmental temperature. Only values of 'C' or 'F' are acceptable. | Match | Invalid %Domain%VAL value for ENVTEMPU |
|
|
| SE2366 | TXVAL value must be a number, a semicolon-delimited string containing numbers without spaces, or 'SEE PROTOCOL' when TXPARMCD='TRTDOS' | Regex | Invalid value for TXVAL for TRTDOS |
|
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 | |
| COGRPID | Group ID | text | 200 | |
| COREFID | Reference ID | text | 200 | |
| COSPID | Sponsor-Defined Identifier | text | 200 | |
| COSEQ | Sequence Number |
|
float | 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 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| CODTC | Date/Time of Comment | datetime | 200 | |
| CODY | Study Day of Comment | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not populated |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
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 | |
| RFCSTDTC | Date/Time of First Challenge Agent Admin | datetime | 200 | |
| RFCENDTC | Date/Time of Last Challenge Agent Admin | 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 Unit | 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 | |
| SETCD | Set Code |
|
text | 200 |
| DMXFN | External File Path | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| DMDTC | Date/Time of Collection | datetime | 200 | |
| DMDY | Study Day of Collection | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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% |
|
|
| SD1259 | The value of Set Code (SETCD) should be no more than 8 characters in length. | Regex | Invalid value for SETCD |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1403 | Date/Time of First Challenge Agent Admin (RFCSTDTC) variable value must be less than or equal to Date/Time of Last Challenge Agent Admin (RFCENDTC). | Condition | RFCSTDTC date is after RFCENDTC |
|
|
| SD1404 | Value for Date/Time of Last Challenge Agent Admin (RFXENDTC) variable must be populated when Date/Time of First Challenge Agent Admin (RFXSTDTC) variable value is provided. | Condition | Missing value for RFCENDTC when RFCSTDTC is provided |
|
|
| SD1405 | Date/Time of First Challenge Agent Admin (RFCSTDTC) variable must be populated when Date/Time of Last Challenge Agent Admin (RFXENDTC) variable value is provided. | Condition | Missing value for RFCSTDTC when RFCENDTC is provided |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE0070 | 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 where ARMCD is not populated. | Lookup | No Exposure record found for subject |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2311 | Set Code (SETCD) values should match entries in the Trial Sets (TX) dataset. | Lookup | Invalid SETCD |
|
|
| SE2319 | All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, and VS domains. | Lookup | No baseline flag record in %Domain.From% for subject |
|
|
| SE2371 | Reference Start Date (RFSTDTC) variable value must be equal to the first Treatment Start Date (EXSTDTC) unless the animal is a replacement. | Condition | RFSTDTC does not equal the first treatment date (EXSTDTC) |
|
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 | |
| SESTDTC | Start Date/Time of Element |
|
datetime | 200 |
| SEENDTC | End Date/Time of Element | datetime | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| SEUPDES | Description of Unplanned Element | text | 200 | |
| SEDTC | Date/Time of Collection | datetime | 200 | |
| SESTDY | Study Day of Start of Element | integer | 200 | |
| SEENDY | Study Day of End of Element | integer | 200 | |
| SEDY | Study Day of Visit/Collection/Exam | 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 |
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2351 | End Date/Time of Element (SEENDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | SEENDTC is after the latest Disposition date |
|
|
| SE2357 | In the Subject Elements (SE) domain, for each subject, each Element should have a different start date. | Unique | Duplicate SESTDTC within USUBJID |
|
Interventions
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __RECID | Invariant Record Identifier | 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 | |
| __TDOSD | Toxic/Physiologic Dose Descr | text | 200 | |
| __FTDOSD | Factor for Toxic/Physiologic Dose Descr | float | 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 | |
| __USCHFL | Unscheduled Flag | text | 200 | |
| __RSTIND | Restraint Indicator | text | 200 | |
| __RSTMOD | Restraint Mode | 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 | |
| __NOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| __NOMLBL | Label for Nominal Study Day | text | 200 | |
| __XDY | Day of Obs Relative to Exposure | integer | 200 | |
| __XSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| __XENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| __CHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
Procedure Agents
| 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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| AGSEQ | Sequence Number |
|
float | 200 |
| AGGRPID | Group ID | text | 200 | |
| AGREFID | Reference ID | text | 200 | |
| AGRECID | Invariant Record Identifier | text | 200 | |
| AGSPID | Sponsor-Defined Identifier | text | 200 | |
| AGLNKID | Link ID | text | 200 | |
| AGLNKGRP | Link Group ID | text | 200 | |
| AGTRT | Reported Agent Name |
|
text | 200 |
| AGMODIFY | Modified Treatment Name | text | 200 | |
| AGDECOD | Standardized Treatment Name | text | 200 | |
| AGMOOD | Mood | text | 200 | |
| AGCAT | Category of Agent | text | 200 | |
| AGSCAT | Subcategory | text | 200 | |
| AGPRESP | Pre-specified | text | 200 | |
| AGOCCUR | Occurrence Indicator | text | 200 | |
| AGSTAT | Completion Status | text | 200 | |
| AGREASND | Reason Medication Not Collected | text | 200 | |
| AGINDC | Indication | text | 200 | |
| AGCLAS | Class | text | 200 | |
| AGCLASCD | Class Code | text | 200 | |
| AGDOSE | Dose per Administration | float | 200 | |
| AGDOSTXT | Dose Description | text | 200 | |
| AGDOSU | Dose Units | text | 200 | |
| AGTDOSD | Toxic/Physiologic Dose Descr | text | 200 | |
| AGFTDOSD | Factor for Toxic/Physiologic Dose Descr | float | 200 | |
| AGDOSFRM | Dose Form | text | 200 | |
| AGDOSFRQ | Dosing Frequency per Interval | text | 200 | |
| AGDOSTOT | Total Daily Dose | float | 200 | |
| AGDOSRGM | Intended Dose Regimen | text | 200 | |
| AGROUTE | Route of Administration | text | 200 | |
| AGLOT | Lot Number | text | 200 | |
| AGLOC | Location of Dose Administration | text | 200 | |
| AGLAT | Laterality | text | 200 | |
| AGDIR | Directionality | text | 200 | |
| AGPORTOT | Portion or Totality | text | 200 | |
| AGFAST | Fasting Status | text | 200 | |
| AGPSTRG | Pharmaceutical Strength | float | 200 | |
| AGPSTRGU | Pharmaceutical Strength Units | text | 200 | |
| AGTRTV | Treatment Vehicle | text | 200 | |
| AGVAMT | Treatment Vehicle Amount | float | 200 | |
| AGVAMTU | Treatment Vehicle Amount Units | text | 200 | |
| AGADJ | Reason for Dose Adjustment | text | 200 | |
| AGRSDISC | Reason for Treatment Discontinuation | text | 200 | |
| AGUSCHFL | Unscheduled Flag | text | 200 | |
| AGRSTIND | Restraint Indicator | text | 200 | |
| AGRSTMOD | Restraint Mode | 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 | |
| AGDTC | Date/Time of Collection | datetime | 200 | |
| AGSTDTC | Start Date/Time of Agent | datetime | 200 | |
| AGENDTC | End Date/Time of Agent | datetime | 200 | |
| AGDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| AGSTDY | Study Day of Start of Treatment | integer | 200 | |
| AGENDY | Study Day of End of Treatment | integer | 200 | |
| AGNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| AGNOMLBL | Label for Nominal Study Day | text | 200 | |
| AGXDY | Day of Obs Relative to Exposure | integer | 200 | |
| AGXSTDY | Start Day of Chall Agent Rel to Exposure | integer | 200 | |
| AGXENDY | End Day of Chall Agent Rel to Exposure | integer | 200 | |
| AGCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| AGCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| AGCHENDY | End Day of Obs Rel to Chall Agent | integer | 200 | |
| AGDUR | Duration | text | 200 | |
| AGTPT | Planned Time Point Name | text | 200 | |
| AGTPTNUM | Planned Time Point Number | float | 200 | |
| AGELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| AGTPTREF | Time Point Reference | text | 200 | |
| AGRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| AGSTRF | Start Relative to Reference Period | text | 200 | |
| AGENRF | End Relative to Reference Period | text | 200 | |
| AGEVLINT | Evaluation Interval | text | 200 | |
| AGEVINTX | Evaluation Interval Text | text | 200 | |
| AGSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| AGSTTPT | Start Reference Time Point | text | 200 | |
| AGENRTPT | End Relative to Reference Time Point | text | 200 | |
| AGENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| AGSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| AGENINT | Planned End of Assessment Interval | datetime | 200 | |
| AGDETECT | 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 |
|
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
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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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not populated |
|
|
| SD1399 | Start Date/Time of Agent (AGSTDTC) variable value must be greater than or equal to Date/Time of First Challenge Agent Admin (RFCSTDTC). | Condition | AGSTDTC date is before RFCSTDTC |
|
|
| SD1401 | Start Date/Time of Agent (AGSTDTC) variable value must be less than or equal to Date/Time of Last Challenge Agent Admin (RFCENDTC). | Condition | AGSTDTC date is after RFCENDTC |
|
|
| SD1402 | End Date/Time of Agent (AGENDTC) variable value must be less than or equal to Date/Time of Last Challenge Agent Admin (RFCENDTC). | Condition | AGENDTC date is after RFCENDTC |
|
|
| 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 |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
Concomitant/Prior 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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| CMSEQ | Sequence Number |
|
float | 200 |
| CMGRPID | Group ID | text | 200 | |
| CMREFID | Reference ID | text | 200 | |
| CMRECID | Invariant Record Identifier | 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 Treatment Name | text | 200 | |
| CMDECOD | Standardized Treatment Name | text | 200 | |
| CMMOOD | Mood | text | 200 | |
| CMCAT | Category for Medication | text | 200 | |
| CMSCAT | Subcategory for Medication | text | 200 | |
| CMPRESP | Pre-specified | text | 200 | |
| CMOCCUR | Occurrence Indicator | text | 200 | |
| CMSTAT | Completion Status | text | 200 | |
| CMREASND | Reason Not Done | text | 200 | |
| CMINDC | Indication | text | 200 | |
| CMCLAS | Class | text | 200 | |
| CMCLASCD | Class Code | text | 200 | |
| CMDOSE | Dose per Administration | float | 200 | |
| CMDOSTXT | Dose Description | text | 200 | |
| CMDOSU | Dose Units | text | 200 | |
| CMTDOSD | Toxic/Physiologic Dose Descr | text | 200 | |
| CMFTDOSD | Factor for Toxic/Physiologic Dose Descr | float | 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 | |
| CMRSDISC | Reason for Treatment Discontinuation | text | 200 | |
| CMUSCHFL | Unscheduled Flag | text | 200 | |
| CMRSTIND | Restraint Indicator | text | 200 | |
| CMRSTMOD | Restraint Mode | 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 | |
| CMNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| CMNOMLBL | Label for Nominal Study Day | text | 200 | |
| CMXDY | Day of Obs Relative to Exposure | integer | 200 | |
| CMXSTDY | Start Day of Med Rel to Exposure | integer | 200 | |
| CMXENDY | End Day of Med Rel to Exposure | integer | 200 | |
| CMCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| CMCHSTDY | Start Day of Med Rel to Chall Agent | integer | 200 | |
| CMCHENDY | End Day of Med Rel to Chall Agent | integer | 200 | |
| CMDUR | Duration | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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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| 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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| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
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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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| 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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| 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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|
| 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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|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
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| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
Exposure
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| EXSEQ | Sequence Number |
|
float | 200 |
| EXGRPID | Group ID | text | 200 | |
| EXREFID | Reference ID | text | 200 | |
| EXRECID | Invariant Record Identifier | text | 200 | |
| EXSPID | Sponsor-Defined Identifier | text | 200 | |
| EXLNKID | Link ID | text | 200 | |
| EXLNKGRP | Link Group ID | text | 200 | |
| EXTRT | Name of Actual Treatment |
|
text | 200 |
| EXMODIFY | Modified Treatment Name | text | 200 | |
| EXDECOD | Standardized Treatment Name | text | 200 | |
| EXMOOD | Mood | text | 200 | |
| EXCAT | Category | text | 200 | |
| EXSCAT | Subcategory | 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 per Administration | float | 200 | |
| EXDOSTXT | Dose Description | text | 200 | |
| EXDOSU | Dose Units | text | 200 | |
| EXFTDOSD | Factor for Toxic/Physiologic Dose Descr | float | 200 | |
| EXTDOSD | Toxic/Physiologic Dose Descr | 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 | |
| EXMETHOD | Method of 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 | Amount Administered | float | 200 | |
| EXVAMTU | Amount Administered Units | text | 200 | |
| EXADJ | Reason for Dose Adjustment | text | 200 | |
| EXUSCHFL | Unscheduled Flag | text | 200 | |
| EXRSTIND | Restraint Indicator | text | 200 | |
| EXRSTMOD | Restraint Mode | 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 | |
| EXNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| EXNOMLBL | Label for Nominal Study Day | text | 200 | |
| EXXDY | Day of Obs Relative to Exposure | integer | 200 | |
| EXXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| EXXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| EXCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| EXCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| EXCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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% |
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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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| 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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| 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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| 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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| 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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| 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 |
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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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| 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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| 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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| 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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| 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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| 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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| 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 |
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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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| 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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| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1148 | Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain. | Lookup | EXSTDTC date is before EXPSTDTC in TS domain |
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| SE1149 | Start Date/Time of Treatment (EXSTDTC) variable value must be less than or equal to Date/Time of Experimental End Date (EXPENDTC) in Trial Summary (TS) domain. | Lookup | EXSTDTC date is after EXPENDTC in TS domain |
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| SE1150 | End Date/Time of Treatment (EXENDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain. | Lookup | EXENDTC date is before EXPSTDTC in TS domain |
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| SE1151 | End Date/Time of Treatment (EXENDTC) variable value must be less than or equal to Date/Time of Experimental End Date (EXPENDTC) in Trial Summary (TS) domain. | Lookup | EXENDTC date is after EXPENDTC in TS domain |
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| SE1152 | Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Subject Reference Start Date/Time (RFSTDTC). | Condition | EXSTDTC date is before RFSTDTC |
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|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2352 | If Name of Actual Treatment (EXTRT) is not administered, (i.e., Dose per Administration (EXDOSE) is equal to zero or is not provided), then Lot Number (EXLOT) should be null. | Condition | EXLOT is populated when EXDOSE equals 0 or is NULL |
|
|
| SE2353 | If Name of Actual Treatment (EXTRT) is administered, (i.e., Dose per Administration (EXDOSE) is greater than zero), then Lot Number (EXLOT) should also be provided. | Condition | EXLOT is null when EXDOSE is provided |
|
|
| SE2360 | Study Day of Start of Treatment (EXSTDY) variable must be populated, when Study Day of End of Treatment (EXENDY) variable value is provided. | Condition | Missing value for EXSTDY, when EXENDY is provided |
|
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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| PRSEQ | Sequence Number |
|
float | 200 |
| PRGRPID | Group ID | text | 200 | |
| PRREFID | Reference ID | text | 200 | |
| PRRECID | Invariant Record Identifier | 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 Medication Not Collected | text | 200 | |
| PRINDC | Indication | text | 200 | |
| PRCLAS | Class | text | 200 | |
| PRCLASCD | Class Code | text | 200 | |
| PRDOSE | Dose per Administration | float | 200 | |
| PRDOSTXT | Dose Description | text | 200 | |
| PRDOSU | Dose Units | text | 200 | |
| PRTDOSD | Toxic/Physiologic Dose Descr | text | 200 | |
| PRFTDOSD | Factor for Toxic/Physiologic Dose Descr | float | 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 | |
| PRRSDISC | Reason for Treatment Discontinuation | text | 200 | |
| PRUSCHFL | Unscheduled Flag | text | 200 | |
| PRRSTIND | Restraint Indicator | text | 200 | |
| PRRSTMOD | Restraint Mode | 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 | |
| PRNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| PRNOMLBL | Label for Nominal Study Day | text | 200 | |
| PRXDY | Day of Obs Relative to Exposure | integer | 200 | |
| PRXSTDY | Start Day of Proc Rel to Exposure | integer | 200 | |
| PRXENDY | End Day of Proc Rel to Exposure | integer | 200 | |
| PRCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| PRCHSTDY | Start Day of Proc Rel to Chall Agent | integer | 200 | |
| PRCHENDY | End Day of Proc Rel to Chall Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
Events
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __RECID | Invariant Record Identifier | 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 | |
| __USCHFL | Unscheduled Flag | 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 | |
| __NOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| __NOMLBL | Label for Nominal Study Day | text | 200 | |
| __XDY | Day of Obs Relative to Exposure | integer | 200 | |
| __XSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| __XENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| __CHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
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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 |
|
|
| 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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| 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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| 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 |
|
|
| 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 |
|
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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 |
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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 |
|
|
| 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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| 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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| 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 |
|
|
| 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% |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
Disposition
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| DSSEQ | Sequence Number |
|
float | 200 |
| DSGRPID | Group ID | text | 200 | |
| DSREFID | Reference ID | text | 200 | |
| DSRECID | Invariant Record Identifier | 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 | text | 200 | |
| DSSCAT | Subcategory | 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 | |
| DSUSCHFL | Unscheduled Flag | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Disposition | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| DSDTC | Date/Time of Collection | datetime | 200 | |
| DSSTDTC | Date/Time of Disposition |
|
datetime | 200 |
| DSENDTC | End Date/Time of Observation | datetime | 200 | |
| DSDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| DSSTDY | Study Day of Disposition | integer | 200 | |
| DSENDY | Study Day of End of Observation | integer | 200 | |
| DSNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| DSNOMLBL | Label for Nominal Study Day | text | 200 | |
| DSXDY | Day of Obs Relative to Exposure | integer | 200 | |
| DSXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| DSXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| DSCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| DSCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| DSCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2268 | For subjects that have a disposition status in the Disposition (DS) domain that indicates an unscheduled death, the cause of death should be captured in the Death Diagnosis and Details (DD) domain. Standardized Disposition Term (DSDECOD) values for unscheduled death include ACCIDENTAL DEATH, FOUND DEAD, MISSING, MORIBUND SACRIFICE, or NON-MORIBUND SACRIFICE. For SEND v3.1 and later, Unscheduled Flag (DSUSCHFL) should also be set to 'Y'. | Lookup | No record in DD domain for unscheduled death |
|
|
| SE2269 | For subjects that have a disposition status in the Disposition (DS) domain that indicates a scheduled death, the Unscheduled Flag (DSUSCHFL) should not be populated. Standardized Disposition Term (DSDECOD) values for scheduled death include: INTERIM SACRIFICE, TERMINAL SACRIFICE, RECOVERY SACRIFICE, and REMOVED FROM STUDY ALIVE. | Condition | Unscheduled flag is populated for scheduled death |
|
|
| SE2283 | For subjects that have a disposition status in the Disposition (DS) domain that indicates an unscheduled death, the Unscheduled Flag (DSUSCHFL) should be set to 'Y'. Standardized Disposition Term (DSDECOD) values for unscheduled death include: ACCIDENTAL DEATH, FOUND DEAD, MISSING, MORIBUND SACRIFICE, or NON-MORIBUND SACRIFICE. | Condition | Unscheduled flag is not populated for unscheduled death |
|
|
| SE2305 | At least one of these variables or sets of variables must be present and populated in DS: (VISITDY, DSSTDY, or DSNOMDY). These are the required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for post mortem data. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%STDY, or %Domain%NOMDY |
|
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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| MHSEQ | Sequence Number |
|
float | 200 |
| MHGRPID | Group ID | text | 200 | |
| MHREFID | Reference ID | text | 200 | |
| MHRECID | Invariant Record Identifier | 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 | |
| MHEVDTYP | Medical History Event Date Type | text | 200 | |
| MHCAT | Category for Medical History | text | 200 | |
| MHSCAT | Subcategory for Medical History | text | 200 | |
| MHPRESP | Pre-Specified | text | 200 | |
| MHOCCUR | Occurrence Indicator | 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 | |
| MHUSCHFL | Unscheduled Flag | 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 | |
| MHNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| MHNOMLBL | Label for Nominal Study Day | text | 200 | |
| MHXDY | Day of Obs Relative to Exposure | integer | 200 | |
| MHXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| MHXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| MHCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| MHCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| MHCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not populated |
|
|
| 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 |
|
Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __RECID | Invariant Record Identifier | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TESTCD | Test Short Name |
|
text | 200 |
| __TEST | Test Name |
|
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 | |
| __ORREF | Reference Result in 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 | |
| __STREFC | Reference Result in Standard Format | text | 200 | |
| __STREFN | Numeric Reference Result in Std Units | float | 200 | |
| __NRIND | Normal/Reference Range Indicator | text | 200 | |
| __RESCAT | Result Category | text | 200 | |
| __CHRON | Chronicity of Finding | text | 200 | |
| __DISTR | Distribution Pattern of Finding | 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 | |
| __LOBXFL | Last Observation Before Exposure Flag | 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 | |
| __USCHFL | Unscheduled Flag | text | 200 | |
| __REPNUM | Repetition Number | float | 200 | |
| __RSTIND | Restraint Indicator | text | 200 | |
| __RSTMOD | Restraint Mode | 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 | |
| __NOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| __NOMLBL | Label for Nominal Study Day | text | 200 | |
| __XDY | Day of Obs Relative to Exposure | integer | 200 | |
| __XSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| __XENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| __CHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Body Weight Gains
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| BGSEQ | Sequence Number |
|
float | 200 |
| BGGRPID | Group ID | text | 200 | |
| BGREFID | Reference ID | text | 200 | |
| BGRECID | Invariant Record Identifier | text | 200 | |
| BGSPID | Sponsor-Defined Identifier | text | 200 | |
| BGLNKID | Link ID | text | 200 | |
| BGLNKGRP | Link Group ID | text | 200 | |
| BGTESTCD | Test Short Name |
|
text | 200 |
| BGTEST | Test Name |
|
text | 200 |
| BGMODIFY | Modified Term | text | 200 | |
| BGTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| BGCAT | Category | text | 200 | |
| BGSCAT | Subcategory | text | 200 | |
| BGPOS | Position of Subject During Observation | text | 200 | |
| BGBODSYS | Body System or Organ Class | text | 200 | |
| BGORRES | Result or Findings as Collected | text | 200 | |
| BGORRESU | Unit of the Original Result | text | 200 | |
| BGORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| BGORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| BGORREF | Reference Result in Original Units | text | 200 | |
| BGSTRESC | Standardized Result in Character Format | text | 200 | |
| BGSTRESN | Standardized Result in Numeric Format | float | 200 | |
| BGSTRESU | Unit of the Standardized Result | text | 200 | |
| BGSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| BGSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| BGSTNRC | Normal Range for Character Results | text | 200 | |
| BGSTREFC | Reference Result in Standard Format | text | 200 | |
| BGSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| BGNRIND | Normal/Reference Range Indicator | text | 200 | |
| BGRESCAT | Result Category | text | 200 | |
| BGCHRON | Chronicity of Finding | text | 200 | |
| BGDISTR | Distribution Pattern of Finding | text | 200 | |
| BGSTAT | Completion Status | text | 200 | |
| BGREASND | Reason Not Done | text | 200 | |
| BGXFN | External File Path | text | 200 | |
| BGNAM | Laboratory/Vendor Name | text | 200 | |
| BGLOINC | LOINC Code | text | 200 | |
| BGSPEC | Specimen Material Type | text | 200 | |
| BGANTREG | Anatomical Region | text | 200 | |
| BGSPCCND | Specimen Condition | text | 200 | |
| BGSPCUFL | Specimen Usability for the Test | text | 200 | |
| BGLOC | Location Used for the Measurement | text | 200 | |
| BGLAT | Laterality | text | 200 | |
| BGDIR | Directionality | text | 200 | |
| BGPORTOT | Portion or Totality | text | 200 | |
| BGMETHOD | Method of Test or Examination | text | 200 | |
| BGRUNID | Run ID | text | 200 | |
| BGANMETH | Analysis Method | text | 200 | |
| BGLEAD | Lead Identified to Collect Measurements | text | 200 | |
| BGCSTATE | Consciousness State | text | 200 | |
| BGLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| BGBLFL | Baseline Flag | text | 200 | |
| BGFAST | Fasting Status | text | 200 | |
| BGDRVFL | Derived Flag | text | 200 | |
| BGEVAL | Evaluator | text | 200 | |
| BGEVALID | Evaluator Identifier | text | 200 | |
| BGACPTFL | Accepted Record Flag | text | 200 | |
| BGTOX | Toxicity | text | 200 | |
| BGTOXGR | Toxicity Grade | text | 200 | |
| BGSEV | Severity | text | 200 | |
| BGDTHREL | Relationship to Death | text | 200 | |
| BGLLOQ | Lower Limit of Quantitation | float | 200 | |
| BGULOQ | Upper Limit of Quantitation | float | 200 | |
| BGEXCLFL | Exclusion Flag | text | 200 | |
| BGREASEX | Reason for Exclusion | text | 200 | |
| BGUSCHFL | Unscheduled Flag | text | 200 | |
| BGREPNUM | Repetition Number | float | 200 | |
| BGRSTIND | Restraint Indicator | text | 200 | |
| BGRSTMOD | Restraint Mode | 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 | |
| BGDTC | Date/Time Animal Weighed | datetime | 200 | |
| BGSTDTC | Start Date/Time of Observation | datetime | 200 | |
| BGENDTC | End Date/Time Animal Weighed | datetime | 200 | |
| BGDY | Study Day of Start of Interval | integer | 200 | |
| BGSTDY | Study Day of Start of Observation | integer | 200 | |
| BGENDY | Study Day of End of Weight Interval | integer | 200 | |
| BGNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| BGNOMLBL | Label for Nominal Study Day | text | 200 | |
| BGXDY | Day of Obs Relative to Exposure | integer | 200 | |
| BGXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| BGXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| BGCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| BGCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| BGCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| BGDUR | Duration | text | 200 | |
| BGTPT | Planned Time Point Name | text | 200 | |
| BGTPTNUM | Planned Time Point Number | float | 200 | |
| BGELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| BGTPTREF | Time Point Reference | text | 200 | |
| BGRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| BGSTRF | Start Relative to Reference Period | text | 200 | |
| BGENRF | End Relative to Reference Period | text | 200 | |
| BGEVLINT | Evaluation Interval | text | 200 | |
| BGEVINTX | Evaluation Interval Text | text | 200 | |
| BGSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| BGSTTPT | Start Reference Time Point | text | 200 | |
| BGENRTPT | End Relative to Reference Time Point | text | 200 | |
| BGENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| BGSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| BGENINT | Planned End of Assessment Interval | datetime | 200 | |
| BGDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2307 | These variables must be populated: --DY and --ENDY. These are the required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for data associated with a time interval. | Condition | Missing values for all required timing variables: %Domain%DY & %Domain%ENDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Body Weight
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| BWSEQ | Sequence Number |
|
float | 200 |
| BWGRPID | Group ID | text | 200 | |
| BWREFID | Reference ID | text | 200 | |
| BWRECID | Invariant Record Identifier | text | 200 | |
| BWSPID | Sponsor-Defined Identifier | text | 200 | |
| BWLNKID | Link ID | text | 200 | |
| BWLNKGRP | Link Group ID | text | 200 | |
| BWTESTCD | Test Short Name |
|
text | 200 |
| BWTEST | Test Name |
|
text | 200 |
| BWMODIFY | Modified Term | text | 200 | |
| BWTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| BWCAT | Category | text | 200 | |
| BWSCAT | Subcategory | text | 200 | |
| BWPOS | Position of Subject During Observation | text | 200 | |
| BWBODSYS | Body System or Organ Class | text | 200 | |
| BWORRES | Result or Findings as Collected | text | 200 | |
| BWORRESU | Unit of the Original Result | text | 200 | |
| BWORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| BWORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| BWORREF | Reference Result in Original Units | text | 200 | |
| BWSTRESC | Standardized Result in Character Format | text | 200 | |
| BWSTRESN | Standardized Result in Numeric Format | float | 200 | |
| BWSTRESU | Unit of the Standardized Result | text | 200 | |
| BWSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| BWSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| BWSTNRC | Normal Range for Character Results | text | 200 | |
| BWSTREFC | Reference Result in Standard Format | text | 200 | |
| BWSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| BWNRIND | Normal/Reference Range Indicator | text | 200 | |
| BWRESCAT | Result Category | text | 200 | |
| BWCHRON | Chronicity of Finding | text | 200 | |
| BWDISTR | Distribution Pattern of Finding | text | 200 | |
| BWSTAT | Completion Status | text | 200 | |
| BWREASND | Reason Not Done | text | 200 | |
| BWXFN | External File Path | text | 200 | |
| BWNAM | Laboratory/Vendor Name | text | 200 | |
| BWLOINC | LOINC Code | text | 200 | |
| BWSPEC | Specimen Material Type | text | 200 | |
| BWANTREG | Anatomical Region | text | 200 | |
| BWSPCCND | Specimen Condition | text | 200 | |
| BWSPCUFL | Specimen Usability for the Test | text | 200 | |
| BWLOC | Location Used for the Measurement | text | 200 | |
| BWLAT | Laterality | text | 200 | |
| BWDIR | Directionality | text | 200 | |
| BWPORTOT | Portion or Totality | text | 200 | |
| BWMETHOD | Method of Test or Examination | text | 200 | |
| BWRUNID | Run ID | text | 200 | |
| BWANMETH | Analysis Method | text | 200 | |
| BWLEAD | Lead Identified to Collect Measurements | text | 200 | |
| BWCSTATE | Consciousness State | text | 200 | |
| BWLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| BWBLFL | Baseline Flag | text | 200 | |
| BWFAST | Fasting Status | text | 200 | |
| BWDRVFL | Derived Flag | text | 200 | |
| BWEVAL | Evaluator | text | 200 | |
| BWEVALID | Evaluator Identifier | text | 200 | |
| BWACPTFL | Accepted Record Flag | text | 200 | |
| BWTOX | Toxicity | text | 200 | |
| BWTOXGR | Toxicity Grade | text | 200 | |
| BWSEV | Severity | text | 200 | |
| BWDTHREL | Relationship to Death | text | 200 | |
| BWLLOQ | Lower Limit of Quantitation | float | 200 | |
| BWULOQ | Upper Limit of Quantitation | float | 200 | |
| BWEXCLFL | Exclusion Flag | text | 200 | |
| BWREASEX | Reason for Exclusion | text | 200 | |
| BWUSCHFL | Unscheduled Flag | text | 200 | |
| BWREPNUM | Repetition Number | float | 200 | |
| BWRSTIND | Restraint Indicator | text | 200 | |
| BWRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| BWDTC | Date/Time Animal Weighed | datetime | 200 | |
| BWSTDTC | Start Date/Time of Observation | datetime | 200 | |
| BWENDTC | End Date/Time of Observation | datetime | 200 | |
| BWDY | Study Day Animal Weighed | integer | 200 | |
| BWSTDY | Study Day of Start of Observation | integer | 200 | |
| BWENDY | Study Day of End of Observation | integer | 200 | |
| BWNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| BWNOMLBL | Label for Nominal Study Day | text | 200 | |
| BWXDY | Day of Obs Relative to Exposure | integer | 200 | |
| BWXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| BWXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| BWCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| BWCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| BWCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| BWDUR | Duration | text | 200 | |
| BWTPT | Planned Time Point Name | text | 200 | |
| BWTPTNUM | Planned Time Point Number | float | 200 | |
| BWELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| BWTPTREF | Time Point Reference | text | 200 | |
| BWRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| BWSTRF | Start Relative to Reference Period | text | 200 | |
| BWENRF | End Relative to Reference Period | text | 200 | |
| BWEVLINT | Evaluation Interval | text | 200 | |
| BWEVINTX | Evaluation Interval Text | text | 200 | |
| BWSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| BWSTTPT | Start Reference Time Point | text | 200 | |
| BWENRTPT | End Relative to Reference Time Point | text | 200 | |
| BWENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| BWSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| BWENINT | Planned End of Assessment Interval | datetime | 200 | |
| BWDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2271 | For terminal body weight measurements (BWTESTCD/BWTEST = 'TERMBW'/'Terminal Body Weight'), the Study Day Animal Weighed (BWDY) variable value should be the same as the Study Day of Disposition (DSSTDY) variable value in the Disposition (DS) domain. | Lookup | %Domain%DY value when BWTESTCD = 'TERMBW' does not equal DSSTDY value |
|
|
| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Clinical Observations
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| CLSEQ | Sequence Number |
|
float | 200 |
| CLGRPID | Group Identifier | text | 200 | |
| CLREFID | Reference ID | text | 200 | |
| CLRECID | Invariant Record Identifier | text | 200 | |
| CLSPID | Mass Identifier | text | 200 | |
| CLLNKID | Link ID | text | 200 | |
| CLLNKGRP | Link Group ID | text | 200 | |
| CLTESTCD | Test Short Name |
|
text | 200 |
| CLTEST | Test Name |
|
text | 200 |
| CLMODIFY | Modified Term | text | 200 | |
| CLTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| CLCAT | Category for Clinical Observations |
|
text | 200 |
| CLSCAT | Subcategory for Clinical Observations | text | 200 | |
| CLPOS | Position of Subject During Observation | text | 200 | |
| CLBODSYS | Body System or Organ Class | text | 200 | |
| CLORRES | Result or Findings as Collected | text | 200 | |
| CLORRESU | Original Units | text | 200 | |
| CLORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| CLORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| CLORREF | Reference Result in Original Units | text | 200 | |
| CLSTRESC | Standardized Result in Character Format | text | 200 | |
| CLSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| CLSTRESU | Standard Units | text | 200 | |
| CLSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| CLSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| CLSTNRC | Normal Range for Character Results | text | 200 | |
| CLSTREFC | Reference Result in Standard Format | text | 200 | |
| CLSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| CLNRIND | Normal/Reference Range Indicator | text | 200 | |
| CLRESCAT | Result Category | text | 200 | |
| CLCHRON | Chronicity of Finding | text | 200 | |
| CLDISTR | Distribution Pattern of Finding | text | 200 | |
| CLSTAT | Completion Status | text | 200 | |
| CLREASND | Reason Not Done | text | 200 | |
| CLXFN | External File Path | text | 200 | |
| CLNAM | Laboratory/Vendor Name | text | 200 | |
| CLLOINC | LOINC Code | text | 200 | |
| CLSPEC | Specimen Material Type | text | 200 | |
| CLANTREG | Anatomical Region | text | 200 | |
| CLSPCCND | Specimen Condition | text | 200 | |
| CLSPCUFL | Specimen Usability for the Test | text | 200 | |
| CLLOC | Location of a Finding | text | 200 | |
| CLLAT | Laterality | text | 200 | |
| CLDIR | Directionality | text | 200 | |
| CLPORTOT | Portion or Totality | text | 200 | |
| CLMETHOD | Method of Test or Examination | text | 200 | |
| CLRUNID | Run ID | text | 200 | |
| CLANMETH | Analysis Method | text | 200 | |
| CLLEAD | Lead Identified to Collect Measurements | text | 200 | |
| CLCSTATE | Consciousness State | text | 200 | |
| CLLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| CLBLFL | Baseline Flag | text | 200 | |
| CLFAST | Fasting Status | text | 200 | |
| CLDRVFL | Derived Flag | text | 200 | |
| CLEVAL | Evaluator | text | 200 | |
| CLEVALID | Evaluator Identifier | text | 200 | |
| CLACPTFL | Accepted Record Flag | text | 200 | |
| CLTOX | Toxicity | text | 200 | |
| CLTOXGR | Toxicity Grade | text | 200 | |
| CLSEV | Severity | text | 200 | |
| CLDTHREL | Relationship to Death | text | 200 | |
| CLLLOQ | Lower Limit of Quantitation | float | 200 | |
| CLULOQ | Upper Limit of Quantitation | float | 200 | |
| CLEXCLFL | Exclusion Flag | text | 200 | |
| CLREASEX | Reason for Exclusion | text | 200 | |
| CLUSCHFL | Unscheduled Flag | text | 200 | |
| CLREPNUM | Repetition Number | float | 200 | |
| CLRSTIND | Restraint Indicator | text | 200 | |
| CLRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| CLDTC | Date/Time of Observation | datetime | 200 | |
| CLSTDTC | Start Date/Time of Observation | datetime | 200 | |
| CLENDTC | End Date/Time of Observation | datetime | 200 | |
| CLDY | Study Day of Observation | integer | 200 | |
| CLSTDY | Study Day of Start of Observation | integer | 200 | |
| CLENDY | Study Day of End of Observation | integer | 200 | |
| CLNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| CLNOMLBL | Label for Nominal Study Day | text | 200 | |
| CLXDY | Day of Obs Relative to Exposure | integer | 200 | |
| CLXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| CLXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| CLCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| CLCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| CLCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| CLDUR | Duration | text | 200 | |
| CLTPT | Planned Time Point Name | text | 200 | |
| CLTPTNUM | Planned Time Point Number | float | 200 | |
| CLELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| CLTPTREF | Time Point Reference | text | 200 | |
| CLRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| CLSTRF | Start Relative to Reference Period | text | 200 | |
| CLENRF | End Relative to Reference Period | text | 200 | |
| CLEVLINT | Evaluation Interval | text | 200 | |
| CLEVINTX | Evaluation Interval Text | text | 200 | |
| CLSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| CLSTTPT | Start Reference Time Point | text | 200 | |
| CLENRTPT | End Relative to Reference Time Point | text | 200 | |
| CLENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| CLSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| CLENINT | Planned End of Assessment Interval | datetime | 200 | |
| CLDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2239 | Value of Result Category (--RESCAT) should not be identical to that in Test Name (--TEST); Category (--CAT); and/or Subcategory (--SCAT). | Condition | %Domain%RESCAT value is redundant with other variable values |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2244 | Result or Finding in Standard Format (--STRESC) should be populated with the base observation without modifiers. Other relevant components of the Result or Finding in Original Units (--ORRES) finding must be parsed into one or more Qualifier variables and the Supplemental Qualifier --RESMOD. | Condition | %Domain%STRESC is the same as %Domain%ORRES when %Domain%STRESC is not 'NORMAL' or 'UNREMARKABLE' and a Qualifier variable is populated |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2285 | If the examination was completed and there were no findings populated in Result or Finding as Collected (--ORRES), the value must be 'NORMAL' in Standardized Result in Character Format (--STRESC) when using SEND v3.0 (MA, MI, CL) or SEND v3.1 or later (CL only). | Condition | %Domain%STRESC value is not 'NORMAL' when no findings are present |
|
|
| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
|
| SE2367 | Severity (--SEV) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%SEV should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
Cardiovascular Test Results
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| CVSEQ | Sequence Number |
|
float | 200 |
| CVGRPID | Group Identifier | text | 200 | |
| CVREFID | Reference ID | text | 200 | |
| CVRECID | Invariant Record Identifier | text | 200 | |
| CVSPID | Sponsor-Defined Identifier | text | 200 | |
| CVLNKID | Link ID | text | 200 | |
| CVLNKGRP | Link Group ID | text | 200 | |
| CVTESTCD | Test Short Name |
|
text | 200 |
| CVTEST | Test Name |
|
text | 200 |
| CVMODIFY | Modified Term | text | 200 | |
| CVTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| CVCAT | Category | text | 200 | |
| CVSCAT | Subcategory | text | 200 | |
| CVPOS | Position of Subject During Test | text | 200 | |
| CVBODSYS | Body System or Organ Class | text | 200 | |
| CVORRES | Result or Findings as Collected | text | 200 | |
| CVORRESU | Unit of the Original Result | text | 200 | |
| CVORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| CVORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| CVORREF | Reference Result in Original Units | text | 200 | |
| CVSTRESC | Standardized Result in Character Format | text | 200 | |
| CVSTRESN | Standardized Result in Numeric Format | float | 200 | |
| CVSTRESU | Unit of the Standardized Result | text | 200 | |
| CVSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| CVSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| CVSTNRC | Normal Range for Character Results | text | 200 | |
| CVSTREFC | Reference Result in Standard Format | text | 200 | |
| CVSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| CVNRIND | Normal/Reference Range Indicator | text | 200 | |
| CVRESCAT | Result Category | text | 200 | |
| CVCHRON | Chronicity of Finding | text | 200 | |
| CVDISTR | Distribution Pattern of Finding | text | 200 | |
| CVSTAT | Completion Status | text | 200 | |
| CVREASND | Reason Not Done | text | 200 | |
| CVXFN | External File Path | text | 200 | |
| CVNAM | Laboratory/Vendor Name | text | 200 | |
| CVLOINC | LOINC Code | text | 200 | |
| CVSPEC | Specimen Material Type | text | 200 | |
| CVANTREG | Anatomical Region | text | 200 | |
| CVSPCCND | Specimen Condition | text | 200 | |
| CVSPCUFL | Specimen Usability for the Test | text | 200 | |
| CVLOC | Location Used for the Measurement | text | 200 | |
| CVLAT | Laterality | text | 200 | |
| CVDIR | Directionality | text | 200 | |
| CVPORTOT | Portion or Totality | text | 200 | |
| CVMETHOD | Method of Test | text | 200 | |
| CVRUNID | Run ID | text | 200 | |
| CVANMETH | Analysis Method | text | 200 | |
| CVLEAD | Lead Identified to Collect Measurements | text | 200 | |
| CVCSTATE | Consciousness State | text | 200 | |
| CVLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| CVBLFL | Baseline Flag | text | 200 | |
| CVFAST | Fasting Status | text | 200 | |
| CVDRVFL | Derived Flag | text | 200 | |
| CVEVAL | Evaluator | text | 200 | |
| CVEVALID | Evaluator Identifier | text | 200 | |
| CVACPTFL | Accepted Record Flag | text | 200 | |
| CVTOX | Toxicity | text | 200 | |
| CVTOXGR | Toxicity Grade | text | 200 | |
| CVSEV | Severity | text | 200 | |
| CVDTHREL | Relationship to Death | text | 200 | |
| CVLLOQ | Lower Limit of Quantitation | float | 200 | |
| CVULOQ | Upper Limit of Quantitation | float | 200 | |
| CVEXCLFL | Exclusion Flag | text | 200 | |
| CVREASEX | Reason for Exclusion | text | 200 | |
| CVUSCHFL | Unscheduled Flag | text | 200 | |
| CVREPNUM | Repetition Number | float | 200 | |
| CVRSTIND | Restraint Indicator | text | 200 | |
| CVRSTMOD | Restraint Mode | 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 | float | 200 | |
| EPOCH | Epoch | text | 200 | |
| CVDTC | Date/Time of Cardiovascular Test | datetime | 200 | |
| CVSTDTC | Start Date/Time of Observation | datetime | 200 | |
| CVENDTC | End Date/Time of Cardiovascular Test | datetime | 200 | |
| CVDY | Study Day of Cardiovascular Test | integer | 200 | |
| CVSTDY | Study Day of Start of Observation | integer | 200 | |
| CVENDY | Study Day of End of Cardiovascular Test | integer | 200 | |
| CVNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| CVNOMLBL | Label for Nominal Study Day | text | 200 | |
| CVXDY | Day of Obs Relative to Exposure | integer | 200 | |
| CVXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| CVXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| CVCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| CVCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| CVCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| CVDUR | Duration | text | 200 | |
| CVTPT | Planned Time Point Name | text | 200 | |
| CVTPTNUM | Planned Time Point Number | float | 200 | |
| CVELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| CVTPTREF | Time Point Reference | text | 200 | |
| CVRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| CVSTRF | Start Relative to Reference Period | text | 200 | |
| CVENRF | End Relative to Reference Period | text | 200 | |
| CVEVLINT | Evaluation Interval | text | 200 | |
| CVEVINTX | Evaluation Interval Text | text | 200 | |
| CVSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| CVSTTPT | Start Reference Time Point | text | 200 | |
| CVENRTPT | End Relative to Reference Time Point | text | 200 | |
| CVENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| CVSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| CVENINT | Planned End of Assessment Interval | datetime | 200 | |
| CVDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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 |
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| 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 |
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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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| 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 |
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| 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 |
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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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| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
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| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
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| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
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| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
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| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
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| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
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| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
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| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Death Diagnosis and Details
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| DDSEQ | Sequence Number |
|
float | 200 |
| DDGRPID | Group ID | text | 200 | |
| DDREFID | Reference ID | text | 200 | |
| DDRECID | Invariant Record Identifier | text | 200 | |
| DDSPID | Sponsor-Defined Identifier | text | 200 | |
| DDLNKID | Link ID | text | 200 | |
| DDLNKGRP | Link Group ID | text | 200 | |
| DDTESTCD | Death Diagnosis Short Name |
|
text | 200 |
| DDTEST | Death Diagnosis 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 Findings 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 | |
| DDORREF | Reference Result in Original Units | text | 200 | |
| DDSTRESC | Standardized Result in Character 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 | |
| DDSTREFC | Reference Result in Standard Format | text | 200 | |
| DDSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| DDNRIND | Normal/Reference Range Indicator | text | 200 | |
| DDRESCAT | Result Category | text | 200 | |
| DDCHRON | Chronicity of Finding | text | 200 | |
| DDDISTR | Distribution Pattern of Finding | 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 | |
| DDLOBXFL | Last Observation Before Exposure Flag | 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 | |
| DDUSCHFL | Unscheduled Flag | text | 200 | |
| DDREPNUM | Repetition Number | float | 200 | |
| DDRSTIND | Restraint Indicator | text | 200 | |
| DDRSTMOD | Restraint Mode | 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 | datetime | 200 | |
| DDSTDTC | Start Date/Time of Observation | datetime | 200 | |
| DDENDTC | End Date/Time of Observation | datetime | 200 | |
| DDDY | Study Day | integer | 200 | |
| DDSTDY | Study Day of Start of Observation | integer | 200 | |
| DDENDY | Study Day of End of Observation | integer | 200 | |
| DDNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| DDNOMLBL | Label for Nominal Study Day | text | 200 | |
| DDXDY | Day of Obs Relative to Exposure | integer | 200 | |
| DDXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| DDXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| DDCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| DDCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| DDCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2265 | Date/Time of Collection (--DTC) variable value must be greater than or equal to Start Date/Time of latest Disposition (DSSTDTC) for post-mortem Findings domains: Death Diagnosis and Details (DD), Macroscopic Findings (MA), Microscopic Findings (MI), Organ Measurements (OM), Tumor Findings (TF). | Condition | %Domain%DTC is before the latest Disposition date |
|
|
| SE2270 | For a specimen collected or observed post mortem, the Study Day (--DY) variable value should be the same as the Study Day of Disposition (DSSTDY) variable value in the Disposition (DS) domain. | Lookup | %Domain%DY value does not equal DSSTDY value |
|
|
| SE2286 | For subjects that have a disposition status in the Disposition (DS) domain that indicates a scheduled death, no records should be present in the Death Diagnosis and Details (DD) domain. Standardized Disposition Term (DSDECOD) values for scheduled death include: INTERIM SACRIFICE, TERMINAL SACRIFICE, RECOVERY SACRIFICE, and REMOVED FROM STUDY ALIVE. | Lookup | Record present in DD domain for scheduled death |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
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 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| EGSEQ | Sequence Number |
|
float | 200 |
| EGGRPID | Group Identifier | text | 200 | |
| EGREFID | ECG Reference Identifier | text | 200 | |
| EGRECID | Invariant Record Identifier | text | 200 | |
| EGSPID | Sponsor-Defined Identifier | text | 200 | |
| EGLNKID | Link ID | text | 200 | |
| EGLNKGRP | Link Group ID | text | 200 | |
| EGTESTCD | ECG Test Short Name |
|
text | 200 |
| EGTEST | ECG Test Name |
|
text | 200 |
| EGMODIFY | Modified Term | text | 200 | |
| EGTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| EGCAT | Category for ECG | text | 200 | |
| EGSCAT | Subcategory | text | 200 | |
| EGPOS | ECG Position of Subject | text | 200 | |
| EGBODSYS | Body System or Organ Class | text | 200 | |
| EGORRES | Result or Findings as Collected | text | 200 | |
| EGORRESU | Unit of the Original Result | text | 200 | |
| EGORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| EGORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| EGORREF | Reference Result in Original Units | text | 200 | |
| EGSTRESC | Standardized Result in Character Format | text | 200 | |
| EGSTRESN | Standardized Result in Numeric Format | float | 200 | |
| EGSTRESU | Unit of the Standardized Result | 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 | |
| EGSTREFC | Reference Result in Standard Format | text | 200 | |
| EGSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| EGNRIND | Normal/Reference Range Indicator | text | 200 | |
| EGRESCAT | Result Category | text | 200 | |
| EGCHRON | Chronicity of Finding | text | 200 | |
| EGDISTR | Distribution Pattern of Finding | text | 200 | |
| EGSTAT | Completion Status | text | 200 | |
| EGREASND | Reason Not Done | text | 200 | |
| EGXFN | ECG External File Name | text | 200 | |
| EGNAM | Laboratory 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 Used for Measurement | text | 200 | |
| EGCSTATE | Consciousness State | text | 200 | |
| EGLOBXFL | Last Observation Before Exposure Flag | 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 | Exclusion Flag | text | 200 | |
| EGREASEX | Reason for Exclusion | text | 200 | |
| EGUSCHFL | Unscheduled Flag | text | 200 | |
| EGREPNUM | Repetition Number | float | 200 | |
| EGRSTIND | Restraint Indicator | text | 200 | |
| EGRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| EGDTC | Date/Time of ECG Collection | datetime | 200 | |
| EGSTDTC | Start Date/Time of Observation | datetime | 200 | |
| EGENDTC | End Date/Time of ECG Collection | datetime | 200 | |
| EGDY | Study Day of ECG Collection | integer | 200 | |
| EGSTDY | Study Day of Start of Observation | integer | 200 | |
| EGENDY | Study Day of End of ECG Collection | integer | 200 | |
| EGNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| EGNOMLBL | Label for Nominal Study Day | text | 200 | |
| EGXDY | Day of Obs Relative to Exposure | integer | 200 | |
| EGXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| EGXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| EGCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| EGCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| EGCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
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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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
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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% |
|
|
| 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 |
|
|
| 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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| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Food and Water Consumption
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| FWSEQ | Sequence Number |
|
float | 200 |
| FWGRPID | Group Identifier | text | 200 | |
| FWREFID | Reference ID | text | 200 | |
| FWRECID | Invariant Record Identifier | text | 200 | |
| FWSPID | Sponsor-Defined Identifier | text | 200 | |
| FWLNKID | Link ID | text | 200 | |
| FWLNKGRP | Link Group ID | text | 200 | |
| FWTESTCD | Food/Water Consumption Short Name |
|
text | 200 |
| FWTEST | Food/Water Consumption Name |
|
text | 200 |
| FWMODIFY | Modified Term | text | 200 | |
| FWTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| FWCAT | Category | text | 200 | |
| FWSCAT | Subcategory | text | 200 | |
| FWPOS | Position of Subject During Observation | text | 200 | |
| FWBODSYS | Body System or Organ Class | text | 200 | |
| FWORRES | Result or Findings as Collected | text | 200 | |
| FWORRESU | Unit of the Original Result | text | 200 | |
| FWORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| FWORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| FWORREF | Reference Result in Original Units | text | 200 | |
| FWSTRESC | Standardized Result in Character Format | text | 200 | |
| FWSTRESN | Standardized Result in Numeric Format | float | 200 | |
| FWSTRESU | Unit of the Standardized Result | text | 200 | |
| FWSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| FWSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| FWSTNRC | Normal Range for Character Results | text | 200 | |
| FWSTREFC | Reference Result in Standard Format | text | 200 | |
| FWSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| FWNRIND | Normal/Reference Range Indicator | text | 200 | |
| FWRESCAT | Result Category | text | 200 | |
| FWCHRON | Chronicity of Finding | text | 200 | |
| FWDISTR | Distribution Pattern of Finding | text | 200 | |
| FWSTAT | Completion Status | text | 200 | |
| FWREASND | Reason Not Done | text | 200 | |
| FWXFN | External File Path | text | 200 | |
| FWNAM | Laboratory/Vendor Name | text | 200 | |
| FWLOINC | LOINC Code | text | 200 | |
| FWSPEC | Specimen Material Type | text | 200 | |
| FWANTREG | Anatomical Region | text | 200 | |
| FWSPCCND | Specimen Condition | text | 200 | |
| FWSPCUFL | Specimen Usability for the Test | text | 200 | |
| FWLOC | Location Used for the Measurement | text | 200 | |
| FWLAT | Laterality | text | 200 | |
| FWDIR | Directionality | text | 200 | |
| FWPORTOT | Portion or Totality | text | 200 | |
| FWMETHOD | Method of Test or Examination | text | 200 | |
| FWRUNID | Run ID | text | 200 | |
| FWANMETH | Analysis Method | text | 200 | |
| FWLEAD | Lead Identified to Collect Measurements | text | 200 | |
| FWCSTATE | Consciousness State | text | 200 | |
| FWLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| FWBLFL | Baseline Flag | text | 200 | |
| FWFAST | Fasting Status | text | 200 | |
| FWDRVFL | Derived Flag | text | 200 | |
| FWEVAL | Evaluator | text | 200 | |
| FWEVALID | Evaluator Identifier | text | 200 | |
| FWACPTFL | Accepted Record Flag | text | 200 | |
| FWTOX | Toxicity | text | 200 | |
| FWTOXGR | Toxicity Grade | text | 200 | |
| FWSEV | Severity | text | 200 | |
| FWDTHREL | Relationship to Death | text | 200 | |
| FWLLOQ | Lower Limit of Quantitation | float | 200 | |
| FWULOQ | Upper Limit of Quantitation | float | 200 | |
| FWEXCLFL | Exclusion Flag | text | 200 | |
| FWREASEX | Reason for Exclusion | text | 200 | |
| FWUSCHFL | Unscheduled Flag | text | 200 | |
| FWREPNUM | Repetition Number | float | 200 | |
| FWRSTIND | Restraint Indicator | text | 200 | |
| FWRSTMOD | Restraint Mode | 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 | |
| FWDTC | Start Date/Time of Observation | datetime | 200 | |
| FWSTDTC | Start Date/Time of Observation | datetime | 200 | |
| FWENDTC | End Date/Time of Observation | datetime | 200 | |
| FWDY | Study Day of Start of Observation | integer | 200 | |
| FWSTDY | Study Day of Start of Observation | integer | 200 | |
| FWENDY | Study Day of End of Observation | integer | 200 | |
| FWNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| FWNOMLBL | Label for Nominal Study Day | text | 200 | |
| FWXDY | Day of Obs Relative to Exposure | integer | 200 | |
| FWXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| FWXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| FWCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| FWCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| FWCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| FWDUR | Duration | text | 200 | |
| FWTPT | Planned Time Point Name | text | 200 | |
| FWTPTNUM | Planned Time Point Number | float | 200 | |
| FWELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| FWTPTREF | Time Point Reference | text | 200 | |
| FWRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| FWSTRF | Start Relative to Reference Period | text | 200 | |
| FWENRF | End Relative to Reference Period | text | 200 | |
| FWEVLINT | Evaluation Interval | text | 200 | |
| FWEVINTX | Evaluation Interval Text | text | 200 | |
| FWSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| FWSTTPT | Start Reference Time Point | text | 200 | |
| FWENRTPT | End Relative to Reference Time Point | text | 200 | |
| FWENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| FWSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| FWENINT | Planned End of Assessment Interval | datetime | 200 | |
| FWDETECT | 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 |
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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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| 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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2307 | These variables must be populated: --DY and --ENDY. These are the required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for data associated with a time interval. | Condition | Missing values for all required timing variables: %Domain%DY & %Domain%ENDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Laboratory
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| LBSEQ | Sequence Number |
|
float | 200 |
| LBGRPID | Group Identifier | text | 200 | |
| LBREFID | Specimen Identifier | text | 200 | |
| LBRECID | Invariant Record Identifier | 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 Findings as Collected | text | 200 | |
| LBORRESU | Unit of the Original Result | text | 200 | |
| LBORNRLO | Reference Range Lower Limit-Orig Unit | text | 200 | |
| LBORNRHI | Reference Range Upper Limit-Orig Unit | text | 200 | |
| LBORREF | Reference Result in Original Units | text | 200 | |
| LBSTRESC | Standardized Result in Character Format | text | 200 | |
| LBSTRESN | Standardized Result in Numeric Format | float | 200 | |
| LBSTRESU | Unit of the Standardized Result | text | 200 | |
| LBSTNRLO | Reference Range Lower Limit-Std Unit | float | 200 | |
| LBSTNRHI | Reference Range Upper Limit-Std Unit | float | 200 | |
| LBSTNRC | Reference Range for Char Rslt-Std Unit | text | 200 | |
| LBSTREFC | Reference Result in Standard Format | text | 200 | |
| LBSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| LBNRIND | Reference Range Indicator | text | 200 | |
| LBRESCAT | Result Category | text | 200 | |
| LBCHRON | Chronicity of Finding | text | 200 | |
| LBDISTR | Distribution Pattern of Finding | text | 200 | |
| LBSTAT | Completion Status | text | 200 | |
| LBREASND | Reason Not Done | text | 200 | |
| LBXFN | External File Path | text | 200 | |
| LBNAM | Laboratory Name | text | 200 | |
| LBLOINC | LOINC Code | text | 200 | |
| LBSPEC | Specimen Material Type | text | 200 | |
| LBANTREG | Anatomical Region of Specimen | text | 200 | |
| LBSPCCND | Specimen Condition | text | 200 | |
| LBSPCUFL | Specimen Usability for the Test | text | 200 | |
| LBLOC | Specimen Collection Location | text | 200 | |
| LBLAT | Specimen Laterality within Subject | text | 200 | |
| LBDIR | Specimen Directionality within Subject | 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 | |
| LBLOBXFL | Last Observation Before Exposure Flag | 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 | Exclusion Flag | text | 200 | |
| LBREASEX | Reason for Exclusion | text | 200 | |
| LBUSCHFL | Unscheduled Flag | text | 200 | |
| LBREPNUM | Repetition Number | float | 200 | |
| LBRSTIND | Restraint Indicator | text | 200 | |
| LBRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | 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 Observation | 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 | |
| LBNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| LBNOMLBL | Label for Nominal Study Day | text | 200 | |
| LBXDY | Day of Obs Relative to Exposure | integer | 200 | |
| LBXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| LBXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| LBCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| LBCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| LBCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Macroscopic Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| MASEQ | Sequence Number |
|
float | 200 |
| MAGRPID | Group Identifier | text | 200 | |
| MAREFID | Specimen Reference Identifier | text | 200 | |
| MARECID | Invariant Record Identifier | text | 200 | |
| MASPID | Mass Identifier | text | 200 | |
| MALNKID | Link ID | text | 200 | |
| MALNKGRP | Link Group ID | text | 200 | |
| MATESTCD | Macroscopic Examination Short Name |
|
text | 200 |
| MATEST | Macroscopic Examination Name |
|
text | 200 |
| MAMODIFY | Modified Term | text | 200 | |
| MATSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| MACAT | Category | text | 200 | |
| MASCAT | Subcategory | text | 200 | |
| MAPOS | Position of Subject During Observation | text | 200 | |
| MABODSYS | Body System or Organ Class | text | 200 | |
| MAORRES | Result or Findings as Collected | text | 200 | |
| MAORRESU | Original Units | text | 200 | |
| MAORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| MAORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| MAORREF | Reference Result in Original Units | text | 200 | |
| MASTRESC | Standardized Result in Character Format | text | 200 | |
| MASTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| MASTRESU | Standard Units | text | 200 | |
| MASTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| MASTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| MASTNRC | Normal Range for Character Results | text | 200 | |
| MASTREFC | Reference Result in Standard Format | text | 200 | |
| MASTREFN | Numeric Reference Result in Std Units | float | 200 | |
| MANRIND | Normal/Reference Range Indicator | text | 200 | |
| MARESCAT | Result Category | text | 200 | |
| MACHRON | Chronicity of Finding | text | 200 | |
| MADISTR | Distribution Pattern of Finding | text | 200 | |
| MASTAT | Completion Status | text | 200 | |
| MAREASND | Reason Not Done | text | 200 | |
| MAXFN | External File Path | text | 200 | |
| MANAM | Laboratory Name | text | 200 | |
| MALOINC | LOINC Code | text | 200 | |
| MASPEC | Specimen Material Type | text | 200 | |
| MAANTREG | Anatomical Region of Specimen | text | 200 | |
| MASPCCND | Specimen Condition | text | 200 | |
| MASPCUFL | Specimen Usability for the Test | text | 200 | |
| MALOC | Location Used for the Measurement | text | 200 | |
| MALAT | Specimen Laterality within Subject | text | 200 | |
| MADIR | Specimen Directionality within Subject | text | 200 | |
| MAPORTOT | Portion or Totality | text | 200 | |
| MAMETHOD | Method of Test or Examination | text | 200 | |
| MARUNID | Run ID | text | 200 | |
| MAANMETH | Analysis Method | text | 200 | |
| MALEAD | Lead Identified to Collect Measurements | text | 200 | |
| MACSTATE | Consciousness State | text | 200 | |
| MALOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| MABLFL | Baseline Flag | text | 200 | |
| MAFAST | Fasting Status | text | 200 | |
| MADRVFL | Derived Flag | text | 200 | |
| MAEVAL | Evaluator | text | 200 | |
| MAEVALID | Evaluator Identifier | text | 200 | |
| MAACPTFL | Accepted Record Flag | text | 200 | |
| MATOX | Toxicity | text | 200 | |
| MATOXGR | Toxicity Grade | text | 200 | |
| MASEV | Severity | text | 200 | |
| MADTHREL | Relationship to Death | text | 200 | |
| MALLOQ | Lower Limit of Quantitation | float | 200 | |
| MAULOQ | Upper Limit of Quantitation | float | 200 | |
| MAEXCLFL | Exclude from Statistics | text | 200 | |
| MAREASEX | Reason for Exclusion from Statistics | text | 200 | |
| MAUSCHFL | Unscheduled Flag | text | 200 | |
| MAREPNUM | Repetition Number | float | 200 | |
| MARSTIND | Restraint Indicator | text | 200 | |
| MARSTMOD | Restraint Mode | 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 | |
| MADTC | Date/Time | datetime | 200 | |
| MASTDTC | Start Date/Time of Observation | datetime | 200 | |
| MAENDTC | End Date/Time of Observation | datetime | 200 | |
| MADY | Study Day | integer | 200 | |
| MASTDY | Study Day of Start of Observation | integer | 200 | |
| MAENDY | Study Day of End of Observation | integer | 200 | |
| MANOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| MANOMLBL | Label for Nominal Study Day | text | 200 | |
| MAXDY | Day of Obs Relative to Exposure | integer | 200 | |
| MAXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| MAXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| MACHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| MACHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| MACHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| MADUR | Duration | text | 200 | |
| MATPT | Planned Time Point Name | text | 200 | |
| MATPTNUM | Planned Time Point Number | float | 200 | |
| MAELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| MATPTREF | Time Point Reference | text | 200 | |
| MARFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| MASTRF | Start Relative to Reference Period | text | 200 | |
| MAENRF | End Relative to Reference Period | text | 200 | |
| MAEVLINT | Evaluation Interval | text | 200 | |
| MAEVINTX | Evaluation Interval Text | text | 200 | |
| MASTRTPT | Start Relative to Reference Time Point | text | 200 | |
| MASTTPT | Start Reference Time Point | text | 200 | |
| MAENRTPT | End Relative to Reference Time Point | text | 200 | |
| MAENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| MASTINT | Planned Start of Assessment Interval | datetime | 200 | |
| MAENINT | Planned End of Assessment Interval | datetime | 200 | |
| MADETECT | 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 |
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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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| 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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
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| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2242 | Specimen Material Type (MASPEC) is required to be populated when Macroscopic Examination Short Name (MATESTCD)/Macroscopic Examination Name (MATEST) = 'GROSPATH'/'Gross Pathological Observation'. | Condition | Missing value for %Domain%SPEC when %Domain%TESTCD equals 'GROSPATH' |
|
|
| SE2243 | Specimen Material Type (MASPEC) should be null when Macroscopic Examination Short Name (MATESTCD)/Macroscopic Examination Name (MATEST) = 'CLSFUP'/'Clinical Signs Follow-up'. | Condition | %Domain%SPEC variable is populated when %Domain%TESTCD equals 'CLSFUP' |
|
|
| SE2244 | Result or Finding in Standard Format (--STRESC) should be populated with the base observation without modifiers. Other relevant components of the Result or Finding in Original Units (--ORRES) finding must be parsed into one or more Qualifier variables and the Supplemental Qualifier --RESMOD. | Condition | %Domain%STRESC is the same as %Domain%ORRES when %Domain%STRESC is not 'NORMAL' or 'UNREMARKABLE' and a Qualifier variable is populated |
|
|
| SE2270 | For a specimen collected or observed post mortem, the Study Day (--DY) variable value should be the same as the Study Day of Disposition (DSSTDY) variable value in the Disposition (DS) domain. | Lookup | %Domain%DY value does not equal DSSTDY value |
|
|
| SE2276 | Date/Time of Collection (--DTC) variable value must be equal to Start Date/Time of latest Disposition (DSSTDTC) for post-mortem findings in the Macroscopic Findings (MA), Microscopic Findings (MI), and Tumor Findings (TF) domains. | Condition | %Domain%DTC does not equal DSSTDTC |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2284 | If the examination was completed and there were no findings populated in Result or Finding as Collected (--ORRES), the value must be 'UNREMARKABLE' in Standardized Result in Character Format (--STRESC) when using SEND v3.1 or later. | Condition | %Domain%STRESC value is not 'UNREMARKABLE' when no findings are present |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2349 | Relationship to Death (--DTHREL) describes the relationship of a particular finding to the death of a subject. Allowed values for this variable include: 'Y' (Caused death), 'N' (Did not cause death), or 'U' (Unknown). | Match | Invalid value for %Domain%DTHREL |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
|
| SE2367 | Severity (--SEV) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%SEV should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2368 | Relationship to Death (--DTHREL) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%DTHREL should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2369 | Chronicity of Finding (--CHRON) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%CHRON should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2370 | Distribution Pattern of Finding (--DISTR) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%DISTR should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| MBSEQ | Sequence Number |
|
float | 200 |
| MBGRPID | Group ID | text | 200 | |
| MBREFID | Reference ID | text | 200 | |
| MBRECID | Invariant Record Identifier | 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 | text | 200 | |
| MBSCAT | Subcategory | 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 | |
| MBORREF | Reference Result in Original Units | text | 200 | |
| MBSTRESC | Result or Finding in Standard 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 | |
| MBSTREFC | Reference Result in Standard Format | text | 200 | |
| MBSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| MBNRIND | Normal/Reference Range Indicator | text | 200 | |
| MBRESCAT | Result Category | text | 200 | |
| MBCHRON | Chronicity of Finding | text | 200 | |
| MBDISTR | Distribution Pattern of Finding | text | 200 | |
| MBRESLOC | Result Location of Finding | text | 200 | |
| MBSTAT | Completion Status | text | 200 | |
| MBREASND | Reason Not Done | text | 200 | |
| MBXFN | External File Path | text | 200 | |
| MBNAM | Laboratory/Vendor Name | text | 200 | |
| MBLOINC | LOINC Code | text | 200 | |
| MBSPEC | Specimen Material 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 | |
| MBLOBXFL | Last Observation Before Exposure Flag | 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 | |
| MBUSCHFL | Unscheduled Flag | text | 200 | |
| MBREPNUM | Repetition Number | float | 200 | |
| MBRSTIND | Restraint Indicator | text | 200 | |
| MBRSTMOD | Restraint Mode | 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 Collection | datetime | 200 | |
| MBSTDTC | Start Date/Time of Observation | datetime | 200 | |
| MBENDTC | End Date/Time of Observation | datetime | 200 | |
| MBDY | Study Day of Visit/Collection/Exam | integer | 200 | |
| MBSTDY | Study Day of Start of Observation | integer | 200 | |
| MBENDY | Study Day of End of Observation | integer | 200 | |
| MBNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| MBNOMLBL | Label for Nominal Study Day | text | 200 | |
| MBXDY | Day of Collection Rel to Exp | integer | 200 | |
| MBXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| MBXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| MBCHDY | Day of Collection Rel to Chall Agent | integer | 200 | |
| MBCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| MBCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
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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 |
|
|
| 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' |
|
|
| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Microscopic Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| MISEQ | Sequence Number |
|
float | 200 |
| MIGRPID | Group Identifier | text | 200 | |
| MIREFID | Specimen Reference Identifier | text | 200 | |
| MIRECID | Invariant Record Identifier | text | 200 | |
| MISPID | Mass 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 | Measurement, Test or Examination Detail | text | 200 | |
| MICAT | Category | text | 200 | |
| MISCAT | Subcategory | text | 200 | |
| MIPOS | Position of Subject During Observation | text | 200 | |
| MIBODSYS | Body System or Organ Class | text | 200 | |
| MIORRES | Result or Findings as Collected | 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 | |
| MIORREF | Reference Result in Original Units | text | 200 | |
| MISTRESC | Standardized Result in Character 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 | |
| MISTREFC | Reference Result in Standard Format | text | 200 | |
| MISTREFN | Numeric Reference Result in Std Units | float | 200 | |
| MINRIND | Normal/Reference Range Indicator | text | 200 | |
| MIRESCAT | Result Category | text | 200 | |
| MICHRON | Chronicity of Finding | text | 200 | |
| MIDISTR | Distribution Pattern of Finding | text | 200 | |
| MISTAT | Completion Status | text | 200 | |
| MIREASND | Reason Not Done | text | 200 | |
| MIXFN | External File Path | text | 200 | |
| MINAM | Laboratory Name | text | 200 | |
| MILOINC | LOINC Code | text | 200 | |
| MISPEC | Specimen Material Type |
|
text | 200 |
| MIANTREG | Anatomical Region of Specimen | text | 200 | |
| MISPCCND | Specimen Condition | text | 200 | |
| MISPCUFL | Specimen Usability for the Test | text | 200 | |
| MILOC | Location Used for the Measurement | 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 | |
| MILOBXFL | Last Observation Before Exposure Flag | 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 | |
| MIUSCHFL | Unscheduled Flag | text | 200 | |
| MIREPNUM | Repetition Number | float | 200 | |
| MIRSTIND | Restraint Indicator | text | 200 | |
| MIRSTMOD | Restraint Mode | 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 | datetime | 200 | |
| MISTDTC | Start Date/Time of Observation | datetime | 200 | |
| MIENDTC | End Date/Time of Observation | datetime | 200 | |
| MIDY | Study Day | integer | 200 | |
| MISTDY | Study Day of Start of Observation | integer | 200 | |
| MIENDY | Study Day of End of Observation | integer | 200 | |
| MINOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| MINOMLBL | Label for Nominal Study Day | text | 200 | |
| MIXDY | Day of Obs Relative to Exposure | integer | 200 | |
| MIXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| MIXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| MICHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| MICHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| MICHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2228 | Result Category (--RESCAT) should be populated for all abnormal findings, i.e. when Result or Finding in Standard Format (--STRESC) has a value other than 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | Missing %Domain%RESCAT value when %Domain%STRESC is not 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2229 | Result or Finding in Standard Format (--STRESC) values from (NEOPLASM) CT codelist should align with the malignancy status in Result Category (--RESCAT) when --RESCAT = 'BENIGN', 'MALIGNANT' or 'UNDETERMINED'. | Condition | %Domain%STRESC/%Domain%RESCAT mismatch when %Domain%RESCAT = 'BENIGN', 'MALIGNANT' or 'UNDETERMINED' |
|
|
| SE2233 | Result Category (--RESCAT) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%RESCAT should not be populated when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2244 | Result or Finding in Standard Format (--STRESC) should be populated with the base observation without modifiers. Other relevant components of the Result or Finding in Original Units (--ORRES) finding must be parsed into one or more Qualifier variables and the Supplemental Qualifier --RESMOD. | Condition | %Domain%STRESC is the same as %Domain%ORRES when %Domain%STRESC is not 'NORMAL' or 'UNREMARKABLE' and a Qualifier variable is populated |
|
|
| SE2270 | For a specimen collected or observed post mortem, the Study Day (--DY) variable value should be the same as the Study Day of Disposition (DSSTDY) variable value in the Disposition (DS) domain. | Lookup | %Domain%DY value does not equal DSSTDY value |
|
|
| SE2276 | Date/Time of Collection (--DTC) variable value must be equal to Start Date/Time of latest Disposition (DSSTDTC) for post-mortem findings in the Macroscopic Findings (MA), Microscopic Findings (MI), and Tumor Findings (TF) domains. | Condition | %Domain%DTC does not equal DSSTDTC |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2284 | If the examination was completed and there were no findings populated in Result or Finding as Collected (--ORRES), the value must be 'UNREMARKABLE' in Standardized Result in Character Format (--STRESC) when using SEND v3.1 or later. | Condition | %Domain%STRESC value is not 'UNREMARKABLE' when no findings are present |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2349 | Relationship to Death (--DTHREL) describes the relationship of a particular finding to the death of a subject. Allowed values for this variable include: 'Y' (Caused death), 'N' (Did not cause death), or 'U' (Unknown). | Match | Invalid value for %Domain%DTHREL |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
|
| SE2367 | Severity (--SEV) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%SEV should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2368 | Relationship to Death (--DTHREL) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%DTHREL should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2369 | Chronicity of Finding (--CHRON) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%CHRON should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
|
| SE2370 | Distribution Pattern of Finding (--DISTR) should not be populated when Result or Finding in Standard Format (--STRESC) is 'NORMAL', 'UNREMARKABLE' or missing (Completion Status (--STAT) = 'NOT DONE'). | Condition | %Domain%DISTR should not be populated, when %Domain%STRESC is 'NORMAL', 'UNREMARKABLE', or NULL (%Domain%STAT = 'NOT DONE') |
|
Organ Measurements
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| OMSEQ | Sequence Number |
|
float | 200 |
| OMGRPID | Group ID | text | 200 | |
| OMREFID | Reference ID | text | 200 | |
| OMRECID | Invariant Record Identifier | text | 200 | |
| OMSPID | Sponsor-Defined Identifier | text | 200 | |
| OMLNKID | Link ID | text | 200 | |
| OMLNKGRP | Link Group ID | text | 200 | |
| OMTESTCD | Test Short Name |
|
text | 200 |
| OMTEST | Test Name |
|
text | 200 |
| OMMODIFY | Modified Term | text | 200 | |
| OMTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| OMCAT | Category | text | 200 | |
| OMSCAT | Subcategory | text | 200 | |
| OMPOS | Position of Subject During Observation | text | 200 | |
| OMBODSYS | Body System or Organ Class | text | 200 | |
| OMORRES | Result or Findings as Collected | text | 200 | |
| OMORRESU | Unit of the Original Result | text | 200 | |
| OMORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| OMORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| OMORREF | Reference Result in Original Units | text | 200 | |
| OMSTRESC | Standardized Result in Character Format | text | 200 | |
| OMSTRESN | Standardized Result in Numeric Format | float | 200 | |
| OMSTRESU | Unit of the Standardized Result | text | 200 | |
| OMSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| OMSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| OMSTNRC | Normal Range for Character Results | text | 200 | |
| OMSTREFC | Reference Result in Standard Format | text | 200 | |
| OMSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| OMNRIND | Normal/Reference Range Indicator | text | 200 | |
| OMRESCAT | Result Category | text | 200 | |
| OMCHRON | Chronicity of Finding | text | 200 | |
| OMDISTR | Distribution Pattern of Finding | text | 200 | |
| OMSTAT | Completion Status | text | 200 | |
| OMREASND | Reason Not Done | text | 200 | |
| OMXFN | External File Path | text | 200 | |
| OMNAM | Laboratory/Vendor Name | text | 200 | |
| OMLOINC | LOINC Code | text | 200 | |
| OMSPEC | Specimen Material Type |
|
text | 200 |
| OMANTREG | Anatomical Region of Specimen | text | 200 | |
| OMSPCCND | Specimen Condition | text | 200 | |
| OMSPCUFL | Specimen Usability for the Test | text | 200 | |
| OMLOC | Location Used for the Measurement | text | 200 | |
| OMLAT | Specimen Laterality within Subject | text | 200 | |
| OMDIR | Specimen Directionality within Subject | text | 200 | |
| OMPORTOT | Portion or Totality | text | 200 | |
| OMMETHOD | Method of Test or Examination | text | 200 | |
| OMRUNID | Run ID | text | 200 | |
| OMANMETH | Analysis Method | text | 200 | |
| OMLEAD | Lead Identified to Collect Measurements | text | 200 | |
| OMCSTATE | Consciousness State | text | 200 | |
| OMLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| OMBLFL | Baseline Flag | text | 200 | |
| OMFAST | Fasting Status | text | 200 | |
| OMDRVFL | Derived Flag | text | 200 | |
| OMEVAL | Evaluator | text | 200 | |
| OMEVALID | Evaluator Identifier | text | 200 | |
| OMACPTFL | Accepted Record Flag | text | 200 | |
| OMTOX | Toxicity | text | 200 | |
| OMTOXGR | Toxicity Grade | text | 200 | |
| OMSEV | Severity | text | 200 | |
| OMDTHREL | Relationship to Death | text | 200 | |
| OMLLOQ | Lower Limit of Quantitation | float | 200 | |
| OMULOQ | Upper Limit of Quantitation | float | 200 | |
| OMEXCLFL | Exclusion Flag | text | 200 | |
| OMREASEX | Reason for Exclusion | text | 200 | |
| OMUSCHFL | Unscheduled Flag | text | 200 | |
| OMREPNUM | Repetition Number | float | 200 | |
| OMRSTIND | Restraint Indicator | text | 200 | |
| OMRSTMOD | Restraint Mode | 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 | |
| OMDTC | Date/Time Organ Measured | datetime | 200 | |
| OMSTDTC | Start Date/Time of Observation | datetime | 200 | |
| OMENDTC | End Date/Time of Observation | datetime | 200 | |
| OMDY | Study Day of Measurement | integer | 200 | |
| OMSTDY | Study Day of Start of Observation | integer | 200 | |
| OMENDY | Study Day of End of Observation | integer | 200 | |
| OMNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| OMNOMLBL | Label for Nominal Study Day | text | 200 | |
| OMXDY | Day of Obs Relative to Exposure | integer | 200 | |
| OMXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| OMXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| OMCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| OMCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| OMCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| OMDUR | Duration | text | 200 | |
| OMTPT | Planned Time Point Name | text | 200 | |
| OMTPTNUM | Planned Time Point Number | float | 200 | |
| OMELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| OMTPTREF | Time Point Reference | text | 200 | |
| OMRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| OMSTRF | Start Relative to Reference Period | text | 200 | |
| OMENRF | End Relative to Reference Period | text | 200 | |
| OMEVLINT | Evaluation Interval | text | 200 | |
| OMEVINTX | Evaluation Interval Text | text | 200 | |
| OMSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| OMSTTPT | Start Reference Time Point | text | 200 | |
| OMENRTPT | End Relative to Reference Time Point | text | 200 | |
| OMENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| OMSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| OMENINT | Planned End of Assessment Interval | datetime | 200 | |
| OMDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2265 | Date/Time of Collection (--DTC) variable value must be greater than or equal to Start Date/Time of latest Disposition (DSSTDTC) for post-mortem Findings domains: Death Diagnosis and Details (DD), Macroscopic Findings (MA), Microscopic Findings (MI), Organ Measurements (OM), Tumor Findings (TF). | Condition | %Domain%DTC is before the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Pharmacokinetic Concentrations
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| PCSEQ | Sequence Number |
|
float | 200 |
| PCGRPID | Group Identifier | text | 200 | |
| PCREFID | Sample Identifier | text | 200 | |
| PCRECID | Invariant Record Identifier | text | 200 | |
| PCSPID | Sponsor-Defined Identifier | text | 200 | |
| PCLNKID | Link ID | text | 200 | |
| PCLNKGRP | Link Group ID | text | 200 | |
| PCTESTCD | Test Short Name |
|
text | 200 |
| PCTEST | 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 Findings as Collected | text | 200 | |
| PCORRESU | Unit of the Original Result | text | 200 | |
| PCORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PCORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PCORREF | Reference Result in Original Units | text | 200 | |
| PCSTRESC | Standardized Result in Character Format | text | 200 | |
| PCSTRESN | Standardized Result in Numeric Format | float | 200 | |
| PCSTRESU | Unit of the Standardized Result | 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 | |
| PCSTREFC | Reference Result in Standard Format | text | 200 | |
| PCSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| PCNRIND | Normal/Reference Range Indicator | text | 200 | |
| PCRESCAT | Result Category | text | 200 | |
| PCCHRON | Chronicity of Finding | text | 200 | |
| PCDISTR | Distribution Pattern of Finding | text | 200 | |
| PCSTAT | Completion Status | text | 200 | |
| PCREASND | Reason Not Done | text | 200 | |
| PCXFN | External File Path | text | 200 | |
| PCNAM | Laboratory 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 | |
| PCLOBXFL | Last Observation Before Exposure Flag | 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 | Exclusion Flag | text | 200 | |
| PCREASEX | Reason for Exclusion | text | 200 | |
| PCUSCHFL | Unscheduled Flag | text | 200 | |
| PCREPNUM | Repetition Number | float | 200 | |
| PCRSTIND | Restraint Indicator | text | 200 | |
| PCRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | 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 | Study Day of Specimen Collection | integer | 200 | |
| PCSTDY | Study Day of Start of Observation | integer | 200 | |
| PCENDY | Study Day of End of Specimen Collection | integer | 200 | |
| PCNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| PCNOMLBL | Label for Nominal Study Day | text | 200 | |
| PCXDY | Day of Obs Relative to Exposure | integer | 200 | |
| PCXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| PCXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| PCCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| PCCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| PCCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2234 | A numeric interpretation for calculations record (QNAM.PCCALCN) should be included in SUPPPC when the Result or Finding in Standard Format (PCSTRESC) is below the limit of quantification ('BLQ' or 'BQL') per guidance in the FDA Technical Conformance Guide. | Lookup | No record for %Domain%CALCN when %Domain%STRESC is below LOQ |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2308 | PCNOMDY and PCELTM or VISITDY and PCELTM must be present and populated in PC. These are the required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for pharmacokinetic concentrations. | Condition | Missing values for required timing variables: (VISITDY and %Domain%ELTM) or (%Domain%NOMDY and %Domain%ELTM) |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2350 | Lower Limit of Quantitation (--LLOQ) should be presented using the same units as those presented in Standard Units (--STRESU). When --LLOQ is provided, --STRESU should also be populated. | Condition | Missing value for %Domain%STRESU when %Domain%LLOQ is provided |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Palpable Masses
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| PMSEQ | Sequence Number |
|
float | 200 |
| PMGRPID | Group Identifier | text | 200 | |
| PMREFID | Reference ID | text | 200 | |
| PMRECID | Invariant Record Identifier | text | 200 | |
| PMSPID | Mass Identifier | text | 200 | |
| PMLNKID | Link ID | text | 200 | |
| PMLNKGRP | Link Group ID | text | 200 | |
| PMTESTCD | Test Short Name |
|
text | 200 |
| PMTEST | Test Name |
|
text | 200 |
| PMMODIFY | Modified Term | text | 200 | |
| PMTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| PMCAT | Category | text | 200 | |
| PMSCAT | Subcategory | text | 200 | |
| PMPOS | Position of Subject During Observation | text | 200 | |
| PMBODSYS | Body System or Organ Class | text | 200 | |
| PMORRES | Result or Findings as Collected | text | 200 | |
| PMORRESU | Unit of the Original Result | text | 200 | |
| PMORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PMORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PMORREF | Reference Result in Original Units | text | 200 | |
| PMSTRESC | Standardized Result in Character Format | text | 200 | |
| PMSTRESN | Standardized Result in Numeric Format | float | 200 | |
| PMSTRESU | Unit of the Standardized Result | text | 200 | |
| PMSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| PMSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| PMSTNRC | Normal Range for Character Results | text | 200 | |
| PMSTREFC | Reference Result in Standard Format | text | 200 | |
| PMSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| PMNRIND | Normal/Reference Range Indicator | text | 200 | |
| PMRESCAT | Result Category | text | 200 | |
| PMCHRON | Chronicity of Finding | text | 200 | |
| PMDISTR | Distribution Pattern of Finding | text | 200 | |
| PMSTAT | Completion Status | text | 200 | |
| PMREASND | Reason Not Done | text | 200 | |
| PMXFN | External File Path | text | 200 | |
| PMNAM | Laboratory/Vendor Name | text | 200 | |
| PMLOINC | LOINC Code | text | 200 | |
| PMSPEC | Specimen Material Type | text | 200 | |
| PMANTREG | Anatomical Region | text | 200 | |
| PMSPCCND | Specimen Condition | text | 200 | |
| PMSPCUFL | Specimen Usability for the Test | text | 200 | |
| PMLOC | Location of a Finding | text | 200 | |
| PMLAT | Laterality | text | 200 | |
| PMDIR | Directionality | text | 200 | |
| PMPORTOT | Portion or Totality | text | 200 | |
| PMMETHOD | Method of Test or Examination | text | 200 | |
| PMRUNID | Run ID | text | 200 | |
| PMANMETH | Analysis Method | text | 200 | |
| PMLEAD | Lead Identified to Collect Measurements | text | 200 | |
| PMCSTATE | Consciousness State | text | 200 | |
| PMLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| PMBLFL | Baseline Flag | text | 200 | |
| PMFAST | Fasting Status | text | 200 | |
| PMDRVFL | Derived Flag | text | 200 | |
| PMEVAL | Evaluator | text | 200 | |
| PMEVALID | Evaluator Identifier | text | 200 | |
| PMACPTFL | Accepted Record Flag | text | 200 | |
| PMTOX | Toxicity | text | 200 | |
| PMTOXGR | Toxicity Grade | text | 200 | |
| PMSEV | Severity | text | 200 | |
| PMDTHREL | Relationship to Death | text | 200 | |
| PMLLOQ | Lower Limit of Quantitation | float | 200 | |
| PMULOQ | Upper Limit of Quantitation | float | 200 | |
| PMEXCLFL | Exclude from Statistics | text | 200 | |
| PMREASEX | Reason for Exclusion from Statistics | text | 200 | |
| PMUSCHFL | Unscheduled Flag | text | 200 | |
| PMREPNUM | Repetition Number | float | 200 | |
| PMRSTIND | Restraint Indicator | text | 200 | |
| PMRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PMDTC | Date/Time of Observation | datetime | 200 | |
| PMSTDTC | Start Date/Time of Observation | datetime | 200 | |
| PMENDTC | End Date/Time of Observation | datetime | 200 | |
| PMDY | Study Day of Observation | integer | 200 | |
| PMSTDY | Study Day of Start of Observation | integer | 200 | |
| PMENDY | Study Day of End of Observation | integer | 200 | |
| PMNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| PMNOMLBL | Label for Nominal Study Day | text | 200 | |
| PMXDY | Day of Obs Relative to Exposure | integer | 200 | |
| PMXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| PMXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| PMCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| PMCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| PMCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| PMDUR | Duration | text | 200 | |
| PMTPT | Planned Time Point Name | text | 200 | |
| PMTPTNUM | Planned Time Point Number | float | 200 | |
| PMELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| PMTPTREF | Time Point Reference | text | 200 | |
| PMRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| PMSTRF | Start Relative to Reference Period | text | 200 | |
| PMENRF | End Relative to Reference Period | text | 200 | |
| PMEVLINT | Evaluation Interval | text | 200 | |
| PMEVINTX | Evaluation Interval Text | text | 200 | |
| PMSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| PMSTTPT | Start Reference Time Point | text | 200 | |
| PMENRTPT | End Relative to Reference Time Point | text | 200 | |
| PMENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| PMSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| PMENINT | Planned End of Assessment Interval | datetime | 200 | |
| PMDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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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| 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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| 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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| 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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|
| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
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| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
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| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
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| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
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| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
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| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
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| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
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| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Pharmacokinetic Parameters
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier | text | 200 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| PPSEQ | Sequence Number |
|
float | 200 |
| PPGRPID | Group Identifier | text | 200 | |
| PPREFID | Reference ID | text | 200 | |
| PPRECID | Invariant Record Identifier | 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 Findings as Collected | text | 200 | |
| PPORRESU | Unit of the Original Result | text | 200 | |
| PPORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| PPORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| PPORREF | Reference Result in Original Units | text | 200 | |
| PPSTRESC | Standardized Result in Character Format | text | 200 | |
| PPSTRESN | Standardized Result in Numeric Format | float | 200 | |
| PPSTRESU | Unit of the Standardized Result | 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 | |
| PPSTREFC | Reference Result in Standard Format | text | 200 | |
| PPSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| PPNRIND | Normal/Reference Range Indicator | text | 200 | |
| PPRESCAT | Result Category | text | 200 | |
| PPCHRON | Chronicity of Finding | text | 200 | |
| PPDISTR | Distribution Pattern of Finding | text | 200 | |
| PPSTAT | Completion Status | text | 200 | |
| PPREASND | Reason Not Done | 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 | |
| PPLOBXFL | Last Observation Before Exposure Flag | 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 | |
| PPUSCHFL | Unscheduled Flag | text | 200 | |
| PPREPNUM | Repetition Number | float | 200 | |
| PPRSTIND | Restraint Indicator | text | 200 | |
| PPRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| PPDTC | Date/Time of Collection | 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 | |
| PPNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| PPNOMLBL | Label for Nominal Study Day | text | 200 | |
| PPXDY | Day of Obs Relative to Exposure | integer | 200 | |
| PPXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| PPXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| PPCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| PPCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| PPCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| PPEVLINT | Evaluation Interval | text | 200 | |
| PPEVINTX | Evaluation Interval Text | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| PPSTINT | Start of Assessment Interval | text | 200 | |
| PPENINT | End of Assessment Interval | text | 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
|
|
| SE2318 | At least one of these variables or sets of variables must be present and populated in PP: VISITDY or PPNOMDY. These are the required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for pharmacokinetic parameters. | Condition | Missing values for all required set(s) of timing variables: VISITDY or %Domain%NOMDY |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Respiratory Test Results
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| RESEQ | Sequence Number |
|
float | 200 |
| REGRPID | Group Identifier | text | 200 | |
| REREFID | Reference ID | text | 200 | |
| RERECID | Invariant Record Identifier | text | 200 | |
| RESPID | Sponsor-Defined Identifier | text | 200 | |
| RELNKID | Link ID | text | 200 | |
| RELNKGRP | Link Group ID | text | 200 | |
| RETESTCD | Test Short Name |
|
text | 200 |
| RETEST | Test Name |
|
text | 200 |
| REMODIFY | Modified Term | text | 200 | |
| RETSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| RECAT | Category | text | 200 | |
| RESCAT | Subcategory | text | 200 | |
| REPOS | Position of Subject During Test | text | 200 | |
| REBODSYS | Body System or Organ Class | text | 200 | |
| REORRES | Result or Findings as Collected | text | 200 | |
| REORRESU | Unit of the Original Result | text | 200 | |
| REORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| REORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| REORREF | Reference Result in Original Units | text | 200 | |
| RESTRESC | Standardized Result in Character Format | text | 200 | |
| RESTRESN | Standardized Result in Numeric Format | float | 200 | |
| RESTRESU | Unit of the Standardized Result | text | 200 | |
| RESTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| RESTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| RESTNRC | Normal Range for Character Results | text | 200 | |
| RESTREFC | Reference Result in Standard Format | text | 200 | |
| RESTREFN | Numeric Reference Result in Std Units | float | 200 | |
| RENRIND | Normal/Reference Range Indicator | text | 200 | |
| RERESCAT | Result Category | text | 200 | |
| RECHRON | Chronicity of Finding | text | 200 | |
| REDISTR | Distribution Pattern of Finding | text | 200 | |
| RESTAT | Completion Status | text | 200 | |
| REREASND | Reason Not Done | text | 200 | |
| REXFN | External File Path | text | 200 | |
| RENAM | Laboratory/Vendor Name | text | 200 | |
| RELOINC | LOINC Code | text | 200 | |
| RESPEC | Specimen Material Type | text | 200 | |
| REANTREG | Anatomical Region | text | 200 | |
| RESPCCND | Specimen Condition | text | 200 | |
| RESPCUFL | Specimen Usability for the Test | text | 200 | |
| RELOC | Location Used for the Measurement | text | 200 | |
| RELAT | Laterality | text | 200 | |
| REDIR | Directionality | text | 200 | |
| REPORTOT | Portion or Totality | text | 200 | |
| REMETHOD | Method of Test | text | 200 | |
| RERUNID | Run ID | text | 200 | |
| REANMETH | Analysis Method | text | 200 | |
| RELEAD | Lead Identified to Collect Measurements | text | 200 | |
| RECSTATE | Consciousness State | text | 200 | |
| RELOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| REBLFL | Baseline Flag | text | 200 | |
| REFAST | Fasting Status | text | 200 | |
| REDRVFL | Derived Flag | text | 200 | |
| REEVAL | Evaluator | text | 200 | |
| REEVALID | Evaluator Identifier | text | 200 | |
| REACPTFL | Accepted Record Flag | text | 200 | |
| RETOX | Toxicity | text | 200 | |
| RETOXGR | Toxicity Grade | text | 200 | |
| RESEV | Severity | text | 200 | |
| REDTHREL | Relationship to Death | text | 200 | |
| RELLOQ | Lower Limit of Quantitation | float | 200 | |
| REULOQ | Upper Limit of Quantitation | float | 200 | |
| REEXCLFL | Exclusion Flag | text | 200 | |
| REREASEX | Reason for Exclusion | text | 200 | |
| REUSCHFL | Unscheduled Flag | text | 200 | |
| REREPNUM | Repetition Number | float | 200 | |
| RERSTIND | Restraint Indicator | text | 200 | |
| RERSTMOD | Restraint Mode | 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 | float | 200 | |
| EPOCH | Epoch | text | 200 | |
| REDTC | Date/Time of Respiratory Measurement | datetime | 200 | |
| RESTDTC | Start Date/Time of Observation | datetime | 200 | |
| REENDTC | End Date/Time of Respiratory Measurement | datetime | 200 | |
| REDY | Study Day of Respiratory Measurement | integer | 200 | |
| RESTDY | Study Day of Start of Observation | integer | 200 | |
| REENDY | End Study Day of Respiratory Measurement | integer | 200 | |
| RENOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| RENOMLBL | Label for Nominal Study Day | text | 200 | |
| REXDY | Day of Obs Relative to Exposure | integer | 200 | |
| REXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| REXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| RECHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| RECHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| RECHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| REDUR | Duration | text | 200 | |
| RETPT | Planned Time Point Name | text | 200 | |
| RETPTNUM | Planned Time Point Number | float | 200 | |
| REELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| RETPTREF | Time Point Reference | text | 200 | |
| RERFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| RESTRF | Start Relative to Reference Period | text | 200 | |
| REENRF | End Relative to Reference Period | text | 200 | |
| REEVLINT | Evaluation Interval | text | 200 | |
| REEVINTX | Evaluation Interval Text | text | 200 | |
| RESTRTPT | Start Relative to Reference Time Point | text | 200 | |
| RESTTPT | Start Reference Time Point | text | 200 | |
| REENRTPT | End Relative to Reference Time Point | text | 200 | |
| REENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| RESTINT | Planned Start of Assessment Interval | datetime | 200 | |
| REENINT | Planned End of Assessment Interval | datetime | 200 | |
| REDETECT | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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 |
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| 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 |
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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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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|
| 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 |
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| 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 |
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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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|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
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| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
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| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
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| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
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| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
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| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
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| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
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| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
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| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Subject Characteristics
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| SCSEQ | Sequence Number |
|
float | 200 |
| SCGRPID | Group Identifier | text | 200 | |
| SCREFID | Reference ID | text | 200 | |
| SCRECID | Invariant Record Identifier | 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 | text | 200 | |
| SCSCAT | Subcategory | text | 200 | |
| SCPOS | Position of Subject During Observation | text | 200 | |
| SCBODSYS | Body System or Organ Class | text | 200 | |
| SCORRES | Result or Findings as Collected | text | 200 | |
| SCORRESU | Unit of the Original Result | text | 200 | |
| SCORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| SCORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| SCORREF | Reference Result in Original Units | text | 200 | |
| SCSTRESC | Standardized Result in Character Format | text | 200 | |
| SCSTRESN | Standardized Result in Numeric Format | float | 200 | |
| SCSTRESU | Unit of the Standardized Result | 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 | |
| SCSTREFC | Reference Result in Standard Format | text | 200 | |
| SCSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| SCNRIND | Normal/Reference Range Indicator | text | 200 | |
| SCRESCAT | Result Category | text | 200 | |
| SCCHRON | Chronicity of Finding | text | 200 | |
| SCDISTR | Distribution Pattern of Finding | text | 200 | |
| SCSTAT | Completion Status | text | 200 | |
| SCREASND | Reason Not Done | 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 | |
| SCLOBXFL | Last Observation Before Exposure Flag | 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 | |
| SCUSCHFL | Unscheduled Flag | text | 200 | |
| SCREPNUM | Repetition Number | float | 200 | |
| SCRSTIND | Restraint Indicator | text | 200 | |
| SCRSTMOD | Restraint Mode | 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 Collection | integer | 200 | |
| SCSTDY | Study Day of Start of Observation | integer | 200 | |
| SCENDY | Study Day of End of Observation | integer | 200 | |
| SCNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| SCNOMLBL | Label for Nominal Study Day | text | 200 | |
| SCXDY | Day of Obs Relative to Exposure | integer | 200 | |
| SCXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| SCXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| SCCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| SCCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| SCCHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
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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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| 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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Tumor Findings
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| TFSEQ | Sequence Number |
|
float | 200 |
| TFGRPID | Group Identifier | text | 200 | |
| TFREFID | Specimen Identifier | text | 200 | |
| TFRECID | Invariant Record Identifier | text | 200 | |
| TFSPID | Mass Identifier | text | 200 | |
| TFLNKID | Link ID | text | 200 | |
| TFLNKGRP | Link Group ID | text | 200 | |
| TFTESTCD | Tumor Examination Short Name |
|
text | 200 |
| TFTEST | Tumor Examination Name |
|
text | 200 |
| TFMODIFY | Modified Term | text | 200 | |
| TFTSTDTL | Measurement, Test or Examination Detail | text | 200 | |
| TFCAT | Category | text | 200 | |
| TFSCAT | Subcategory | text | 200 | |
| TFPOS | Position of Subject During Observation | text | 200 | |
| TFBODSYS | Body System or Organ Class | text | 200 | |
| TFORRES | Result or Findings as Collected | text | 200 | |
| TFORRESU | Original Units | text | 200 | |
| TFORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| TFORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| TFORREF | Reference Result in Original Units | text | 200 | |
| TFSTRESC | Standardized Result in Character Format | text | 200 | |
| TFSTRESN | Numeric Result/Finding in Standard Units | float | 200 | |
| TFSTRESU | Standard Units | text | 200 | |
| TFSTNRLO | Normal Range Lower Limit-Standard Units | float | 200 | |
| TFSTNRHI | Normal Range Upper Limit-Standard Units | float | 200 | |
| TFSTNRC | Normal Range for Character Results | text | 200 | |
| TFSTREFC | Reference Result in Standard Format | text | 200 | |
| TFSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| TFNRIND | Normal/Reference Range Indicator | text | 200 | |
| TFRESCAT | Tumor Malignancy Status |
|
text | 200 |
| TFCHRON | Chronicity of Finding | text | 200 | |
| TFDISTR | Distribution Pattern of Finding | text | 200 | |
| TFSTAT | Completion Status | text | 200 | |
| TFREASND | Reason Not Done | text | 200 | |
| TFXFN | External File Path | text | 200 | |
| TFNAM | Laboratory Name | text | 200 | |
| TFLOINC | LOINC Code | text | 200 | |
| TFSPEC | Specimen Material Type |
|
text | 200 |
| TFANTREG | Anatomical Region of Specimen | text | 200 | |
| TFSPCCND | Specimen Condition | text | 200 | |
| TFSPCUFL | Specimen Usability for the Test | text | 200 | |
| TFLOC | Location Used for the Measurement | text | 200 | |
| TFLAT | Specimen Laterality within Subject | text | 200 | |
| TFDIR | Specimen Directionality within Subject | text | 200 | |
| TFPORTOT | Portion or Totality | text | 200 | |
| TFMETHOD | Method of Test or Examination | text | 200 | |
| TFRUNID | Run ID | text | 200 | |
| TFANMETH | Analysis Method | text | 200 | |
| TFLEAD | Lead Identified to Collect Measurements | text | 200 | |
| TFCSTATE | Consciousness State | text | 200 | |
| TFLOBXFL | Last Observation Before Exposure Flag | text | 200 | |
| TFBLFL | Baseline Flag | text | 200 | |
| TFFAST | Fasting Status | text | 200 | |
| TFDRVFL | Derived Flag | text | 200 | |
| TFEVAL | Evaluator | text | 200 | |
| TFEVALID | Evaluator Identifier | text | 200 | |
| TFACPTFL | Accepted Record Flag | text | 200 | |
| TFTOX | Toxicity | text | 200 | |
| TFTOXGR | Toxicity Grade | text | 200 | |
| TFSEV | Severity | text | 200 | |
| TFDTHREL | Relationship to Death |
|
text | 200 |
| TFLLOQ | Lower Limit of Quantitation | float | 200 | |
| TFULOQ | Upper Limit of Quantitation | float | 200 | |
| TFEXCLFL | Exclude from Statistics | text | 200 | |
| TFREASEX | Reason for Exclusion from Statistics | text | 200 | |
| TFUSCHFL | Unscheduled Flag | text | 200 | |
| TFREPNUM | Repetition Number | float | 200 | |
| TFRSTIND | Restraint Indicator | text | 200 | |
| TFRSTMOD | Restraint Mode | 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 | |
| TFDTC | Date/Time | datetime | 200 | |
| TFSTDTC | Start Date/Time of Observation | datetime | 200 | |
| TFENDTC | End Date/Time of Observation | datetime | 200 | |
| TFDY | Study Day | integer | 200 | |
| TFSTDY | Study Day of Start of Observation | integer | 200 | |
| TFENDY | Study Day of End of Observation | integer | 200 | |
| TFNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| TFNOMLBL | Label for Nominal Study Day | text | 200 | |
| TFXDY | Day of Obs Relative to Exposure | integer | 200 | |
| TFXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| TFXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| TFCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| TFCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| TFCHENDY | End Day of Obs Rel to Challenge Agent | integer | 200 | |
| TFDUR | Duration | text | 200 | |
| TFTPT | Planned Time Point Name | text | 200 | |
| TFTPTNUM | Planned Time Point Number | float | 200 | |
| TFELTM | Planned Elapsed Time from Time Point Ref | text | 200 | |
| TFTPTREF | Time Point Reference | text | 200 | |
| TFRFTDTC | Date/Time of Reference Time Point | datetime | 200 | |
| TFSTRF | Start Relative to Reference Period | text | 200 | |
| TFENRF | End Relative to Reference Period | text | 200 | |
| TFEVLINT | Evaluation Interval | text | 200 | |
| TFEVINTX | Evaluation Interval Text | text | 200 | |
| TFSTRTPT | Start Relative to Reference Time Point | text | 200 | |
| TFSTTPT | Start Reference Time Point | text | 200 | |
| TFENRTPT | End Relative to Reference Time Point | text | 200 | |
| TFENTPT | End Reference Time Point | text | 200 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 200 | |
| TFSTINT | Planned Start of Assessment Interval | datetime | 200 | |
| TFENINT | Planned End of Assessment Interval | datetime | 200 | |
| TFDETECT | Time in Days to Detection of Tumor |
|
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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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 |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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 |
|
|
| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
|
|
| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE0083 | Time in Days to Detection of Tumor (TFDETECT) should be less than or equal to the Study Day of Disposition of the latest Disposition Event (DSSTDY). | Lookup | TFDETECT is after DSSTDY |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2229 | Result or Finding in Standard Format (--STRESC) values from (NEOPLASM) CT codelist should align with the malignancy status in Result Category (--RESCAT) when --RESCAT = 'BENIGN', 'MALIGNANT' or 'UNDETERMINED'. | Condition | %Domain%STRESC/%Domain%RESCAT mismatch when %Domain%RESCAT = 'BENIGN', 'MALIGNANT' or 'UNDETERMINED' |
|
|
| SE2270 | For a specimen collected or observed post mortem, the Study Day (--DY) variable value should be the same as the Study Day of Disposition (DSSTDY) variable value in the Disposition (DS) domain. | Lookup | %Domain%DY value does not equal DSSTDY value |
|
|
| SE2276 | Date/Time of Collection (--DTC) variable value must be equal to Start Date/Time of latest Disposition (DSSTDTC) for post-mortem findings in the Macroscopic Findings (MA), Microscopic Findings (MI), and Tumor Findings (TF) domains. | Condition | %Domain%DTC does not equal DSSTDTC |
|
|
| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Vital Signs
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| DOMAIN | Domain Abbreviation |
|
text | 200 |
| USUBJID | Unique Subject Identifier |
|
text | 200 |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| VSSEQ | Sequence Number |
|
float | 200 |
| VSGRPID | Group Identifier | text | 200 | |
| VSREFID | Reference ID | text | 200 | |
| VSRECID | Invariant Record Identifier | 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 Findings as Collected | text | 200 | |
| VSORRESU | Unit of the Original Result | text | 200 | |
| VSORNRLO | Normal Range Lower Limit-Original Units | text | 200 | |
| VSORNRHI | Normal Range Upper Limit-Original Units | text | 200 | |
| VSORREF | Reference Result in Original Units | text | 200 | |
| VSSTRESC | Standardized Result in Character Format | text | 200 | |
| VSSTRESN | Standardized Result in Numeric Format | float | 200 | |
| VSSTRESU | Unit of the Standardized Result | 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 | |
| VSSTREFC | Reference Result in Standard Format | text | 200 | |
| VSSTREFN | Numeric Reference Result in Std Units | float | 200 | |
| VSNRIND | Normal/Reference Range Indicator | text | 200 | |
| VSRESCAT | Result Category | text | 200 | |
| VSCHRON | Chronicity of Finding | text | 200 | |
| VSDISTR | Distribution Pattern of Finding | text | 200 | |
| VSSTAT | Completion Status | text | 200 | |
| VSREASND | Reason Not Done | 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 | |
| VSLOBXFL | Last Observation Before Exposure Flag | 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 | Exclusion Flag | text | 200 | |
| VSREASEX | Reason for Exclusion | text | 200 | |
| VSUSCHFL | Unscheduled Flag | text | 200 | |
| VSREPNUM | Repetition Number | float | 200 | |
| VSRSTIND | Restraint Indicator | text | 200 | |
| VSRSTMOD | Restraint Mode | text | 200 | |
| VISITNUM | Visit Number | float | 200 | |
| VISIT | Visit Name | text | 200 | |
| VISITDY | Planned Study Day of Collection | integer | 200 | |
| TAETORD | Planned Order of Element within Arm | integer | 200 | |
| EPOCH | Epoch | text | 200 | |
| VSDTC | Date/Time of Measurement | datetime | 200 | |
| VSSTDTC | Start Date/Time of Observation | datetime | 200 | |
| VSENDTC | End Date/Time of Measurement | datetime | 200 | |
| VSDY | Study Day of Vital Signs Measurement | integer | 200 | |
| VSSTDY | Study Day of Start of Observation | integer | 200 | |
| VSENDY | Study Day of End of Measurement | integer | 200 | |
| VSNOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| VSNOMLBL | Label for Nominal Study Day | text | 200 | |
| VSXDY | Day of Obs Relative to Exposure | integer | 200 | |
| VSXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| VSXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| VSCHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| VSCHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| VSCHENDY | End Day of Obs Rel to Challenge Agent | 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 Time Point Reference | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
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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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| 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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
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| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
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| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
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| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
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| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
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| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
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| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
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| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
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| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
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| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
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| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
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| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
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| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
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| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
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| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
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| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
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| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
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| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not 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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| SE0009 | Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. | Condition | Missing values for both %Domain%DTC and %Domain%DY variables |
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| SE0011 | Time Point Reference (--TPTREF) variable values should be provided when Date/Time of Reference Time Point (--RFTDTC) variable values are populated. | Condition | Missing value for %Domain%TPTREF when %Domain%RFTDTC is provided |
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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE1125 | 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 if present, Category and/or Subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%ELTM within %Domain%TPT, %Domain%TPTREF, %Domain%CAT and/or %Domain%SCAT |
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| SE1126 | All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable. Uniqueness for these time points is determined by a combination of the domain, study day, and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPT within %Domain%TPTNUM, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1127 | All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable. Uniqueness for these time points is determined by a combination of the domain, Study Day (--DY), and, if present, category and/or subcategory (--CAT/--SCAT). | Unique | Inconsistent value for %Domain%TPTNUM within %Domain%TPT, %Domain%DY, %Domain%CAT and/or %Domain%SCAT |
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| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2266 | The value of Standardized Result in Numeric Format (--STRESN) cannot be less than 0 when the record is not excluded from analysis, i.e., Exclude from Statistics (--EXCLFL) is not 'Y'. This applies for the following domains in SEND: BW, FM, FW, LB, OM, PC, PY, RE, VS. | Condition | Negative value for %Domain%STRESN when %Domain%EXCLFL is not populated |
|
|
| SE2306 | At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY. These are the Required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. | Condition | Missing values for all required set(s) of timing variables: VISITDY, %Domain%DY or %Domain%NOMDY |
|
|
| SE2310 | Status (--STAT) should be NULL when Standardized Result in Character Format (--STRESC ) is provided. | Condition | Value for %Domain%STRESC is populated when %Domain%STAT is 'NOT DONE' |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
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 | |
| NHOID | Non-Host Organism Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| FASEQ | Sequence Number |
|
float | 200 |
| FAGRPID | Group ID | text | 200 | |
| FAREFID | Reference ID | text | 200 | |
| FARECID | Invariant Record Identifier | 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 | text | 200 | |
| FASCAT | Subcategory | 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 | |
| FAORREF | Reference Result in Original Units | text | 200 | |
| FASTRESC | Result or Finding in Standard 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 | |
| FASTREFC | Reference Result in Standard Format | text | 200 | |
| FASTREFN | Numeric Reference Result in Std Units | float | 200 | |
| FANRIND | Normal/Reference Range Indicator | text | 200 | |
| FARESCAT | Result Category | text | 200 | |
| FACHRON | Chronicity of Finding | text | 200 | |
| FADISTR | Distribution Pattern of Finding | text | 200 | |
| FARESLOC | Result Location of Finding | text | 200 | |
| FASTAT | Completion Status | text | 200 | |
| FAREASND | Reason Not Done | 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 | Specimen Collection Location | text | 200 | |
| FALAT | Laterality | text | 200 | |
| FADIR | Directionality | text | 200 | |
| FAPORTOT | Portion or Totality | text | 200 | |
| FAMETHOD | Method of Test or Examination | text | 200 | |
| FARUNID | Run ID | text | 200 | |
| FAANMETH | Analysis Method | text | 200 | |
| FALEAD | Lead Identified to Collect Measurements | text | 200 | |
| FACSTATE | Consciousness State | text | 200 | |
| FALOBXFL | Last Observation Before Exposure Flag | 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 | |
| FAUSCHFL | Unscheduled Flag | text | 200 | |
| FAREPNUM | Repetition Number | float | 200 | |
| FARSTIND | Restraint Indicator | text | 200 | |
| FARSTMOD | Restraint Mode | 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 Visit/Collection/Exam | integer | 200 | |
| FASTDY | Study Day of Start of Observation | integer | 200 | |
| FAENDY | Study Day of End of Observation | integer | 200 | |
| FANOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| FANOMLBL | Label for Nominal Study Day | text | 200 | |
| FAXDY | Day of Obs Relative to Exposure | integer | 200 | |
| FAXSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| FAXENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| FACHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| FACHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| FACHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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' |
|
|
| SD1142 | Applicant should consult the PMDA beforehand if the dataset exceeds the file size specified by PMDA. | Property | Dataset is greater than 5 GB in size |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not populated |
|
|
| 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 |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
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 | |
| APID | Associated Persons Identifier | text | 200 | |
| POOLID | Pool Identifier | text | 200 | |
| SPDEVID | Sponsor Device Identifier | text | 200 | |
| FETUSID | Fetus Identifier | text | 200 | |
| FOCID | Focus of Study-Specific Interest | text | 200 | |
| __SEQ | Sequence Number |
|
float | 200 |
| __GRPID | Group ID | text | 200 | |
| __REFID | Reference ID | text | 200 | |
| __RECID | Invariant Record Identifier | text | 200 | |
| __SPID | Sponsor-Defined Identifier | text | 200 | |
| __LNKID | Link ID | text | 200 | |
| __LNKGRP | Link Group ID | text | 200 | |
| __TESTCD | Test Short Name |
|
text | 200 |
| __TEST | 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 | 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 | |
| __ORREF | Reference Result in 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 | |
| __STREFC | Reference Result in Standard Format | text | 200 | |
| __STREFN | Numeric Reference Result in Std Units | float | 200 | |
| __NRIND | Normal/Reference Range Indicator | text | 200 | |
| __RESCAT | Result Category | text | 200 | |
| __CHRON | Chronicity of Finding | text | 200 | |
| __DISTR | Distribution Pattern of Finding | 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 | |
| __LOBXFL | Last Observation Before Exposure Flag | 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 | |
| __USCHFL | Unscheduled Flag | text | 200 | |
| __REPNUM | Repetition Number | float | 200 | |
| __RSTIND | Restraint Indicator | text | 200 | |
| __RSTMOD | Restraint Mode | 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 | |
| __NOMDY | Nominal Study Day for Tabulations | integer | 200 | |
| __NOMLBL | Label for Nominal Study Day | text | 200 | |
| __XDY | Day of Obs Relative to Exposure | integer | 200 | |
| __XSTDY | Start Day of Obs Relative to Exposure | integer | 200 | |
| __XENDY | End Day of Obs Relative to Exposure | integer | 200 | |
| __CHDY | Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHSTDY | Start Day of Obs Rel to Challenge Agent | integer | 200 | |
| __CHENDY | End Day of Obs Rel to Challenge Agent | 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 | |
| MIDS | Disease Milestone Instance Name | text | 200 | |
| RELMIDS | Temporal Relation to Milestone Instance | text | 200 | |
| MIDSDTC | Disease Milestone Instance Date/Time | datetime | 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 |
|---|---|---|---|---|---|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1131 | A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL='Y'). | Condition | Missing %Domain%STRESC value for Baseline record |
|
|
| 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% |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SD1381 | Day of Obs Relative to Exposure (--XDY) variable value should be populated as defined by CDISC standards: --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) +1 if --DTC is on or after RFXSTDTC; --XDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --DTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XDY variable |
|
|
| SD1382 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated as defined by CDISC standards: --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) +1 if --STDTC is on or after RFXSTDTC; --XSTDY = (date portion of --STDTC) - (date portion of RFXSTDTC) if --STDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XSTDY variable |
|
|
| SD1383 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated as defined by CDISC standards: --XENDY = (date portion of --ENDTC) - (date portion of RFXSTDTC) +1 if --ENDTC is on or after RFXSTDTC; --XENDY = (date portion of --DTC) - (date portion of RFXSTDTC) if --ENDTC precedes RFXSTDTC. | Condition | Incorrect value for %Domain%XENDY variable |
|
|
| SD1384 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated as defined by CDISC standards: --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) +1 if --DTC is on or after RFCSTDTC; --CHDY = (date portion of --DTC) - (date portion of RFCSTDTC) if --DTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHDY variable |
|
|
| SD1385 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated as defined by CDISC standards: --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) +1 if --STDTC is on or after RFCSTDTC; --CHSTDY = (date portion of --STDTC) - (date portion of RFCSTDTC) if --STDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHSTDY variable |
|
|
| SD1386 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated as defined by CDISC standards: --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) +1 if --ENDTC is on or after RFCSTDTC; --CHENDY = (date portion of --ENDTC) - (date portion of RFCSTDTC) if --ENDTC precedes RFCSTDTC. | Condition | Incorrect value for %Domain%CHENDY variable |
|
|
| SD1387 | Day of Obs relative to Exposure (--XDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XDY variable value is imputed |
|
|
| SD1388 | Start Day of Obs relative to Exposure (--XSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is imputed |
|
|
| SD1389 | End Day of Obs Relative to Exposure (--XENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%XENDY variable value is imputed |
|
|
| SD1390 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should not be imputed. It may only be populated when both Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHDY variable value is imputed |
|
|
| SD1391 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should not be imputed. It may only be populated when both Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is imputed |
|
|
| SD1392 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should not be imputed. It may only be populated when both End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is imputed |
|
|
| SD1393 | Day of Obs Relative to Exposure (--XDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XDY variable value is not populated |
|
|
| SD1394 | Start Day of Obs Relative to Exposure (--XSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XSTDY variable value is not populated |
|
|
| SD1395 | End Day of Obs Relative to Exposure (--XENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Study Treatment (RFXSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%XENDY variable value is not populated |
|
|
| SD1396 | Day of Obs Rel to Challenge Agent (--CHDY) variable value should be populated when Date/Time of Collection (--DTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHDY variable value is not populated |
|
|
| SD1397 | Start Day of Obs Rel to Challenge Agent (--CHSTDY) variable value should be populated when Start Date/Time of Observation (--STDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHSTDY variable value is not populated |
|
|
| SD1398 | End Day of Obs Rel to Challenge Agent (--CHENDY) variable value should be populated when End Date/Time of Observation (--ENDTC) and Date/Time of First Challenge Agent Admin (RFCSTDTC) variables values are provided, and both of them include complete date parts. | Condition | %Domain%CHENDY variable value is not populated |
|
|
| 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 |
|
|
| SE1157 | Restraint Mode (--RSTMOD) variable should not be populated when Restraint Indicator (--RSTIND) variable is not 'Y' (--RSTIND = 'N' or NULL). | Condition | Non-missing value for %Domain%RSTMOD when %Domain%RSTIND = 'N' or NULL |
|
|
| SE1158 | Restraint Mode (--RSTMOD) variable should be populated when Restraint Indicator (--RSTIND) variable is set to 'Y'. | Condition | Missing value for %Domain%RSTMOD when %Domain%RSTIND = 'Y' |
|
|
| SE2240 | End Date/Time of Observation (--ENDTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%ENDTC is after the latest Disposition date |
|
|
| SE2241 | Date/Time of Observation (--DTC) for an animal's live-phase findings should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). | Condition | %Domain%DTC is after the latest Disposition date |
|
|
| SE2354 | Exclude from Statistics (--EXCLFL) should be set to 'Y' when Reason for Exclusion from Statistics (--REASEX) is populated. | Required | Missing value for %Domain%EXCLFL when %Domain%REASEX is provided |
|
Pool Definition
| Variable | Description | Required | Data Type | Length |
|---|---|---|---|---|
| STUDYID | Study Identifier |
|
text | 200 |
| POOLID | Pool Identifier |
|
text | 200 |
| USUBJID | Unique Subject 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2282 | There should be only one record per subject (USUBJID) within Pool Identifier (POOLID) in the Pool Definition (POOLDEF) domain. | Unique | Duplicate USUBJID within a POOLID |
|
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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
|
|
| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
|
|
| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
|
|
| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
|
|
| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
|
|
| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid 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 |
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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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| 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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| 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 |
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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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| 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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| SD0064 | All Subjects (USUBJID) must be present in Demographics (DM) domain. | Condition | Subject is not present in DM domain |
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| SD0072 | Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data. | Metadata | Invalid RDOMAIN |
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| SD0075 | Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain. | Metadata | Invalid IDVAR |
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| 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 |
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| 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 |
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| 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 |
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| SD1005 | Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain. | Lookup | Invalid STUDYID |
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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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| 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 |
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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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| SD1049 | Qualifier Variable Label (QLABEL) value may have up to 40 characters. | Regex | Invalid value for QLABEL |
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| 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 |
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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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| 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 |
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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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| 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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| 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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| SD1120 | Comments should be stored in Comments (CO) domain, rather than be put into Supplemental Qualifier (SUPP--) domains. | Condition | Comments in %Domain% domain |
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| 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 |
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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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| 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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| SE0055 | Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model. | Match | SEND/dataset variable type mismatch |
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| SE0056 | Variables described in SEND IG as Required must be included in the dataset. | Find | SEND Required variable %Variable% not found |
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| SE0057 | Variables described in SEND IG as Expected should be included in the dataset. | Find | SEND Expected variable %Variable% not found |
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| SE0063 | Variable Label in the dataset should match the variable label described in SEND 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 | SEND/dataset variable label mismatch |
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| SE1074 | Variables designed only for SDTM human studies must be not included in the SEND dataset. | Find | Variable which can be used only in SDTM |
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| SE2277 | Due to SAS v5 transport file limitations, variables cannot have a length that is greater than 200 characters. For SEND data, this results in loading errors into regulatory nonclinical review tools. The SENDIG should be followed in how to split long character strings appropriately. | Varlength | %Variable% variable length exceeds 200 characters |
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| SE2312 | Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset. | Lookup | Invalid POOLID |
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| SE2378 | The Numeric Interpretation for Calculations (--CALCN) supplemental qualifier variable should only contain numeric values in QVAL. | Condition | QVAL value is not numeric when QNAM = --CALCN |
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