Pinnacle 21 Validator Configuration

Global Rules Section

Dataset Structure
Variable	Description	Required	Data Type	Length

Validation Rules
ID	Description	Validator	Message	Severity
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
SD1020	Demographics (DM) dataset must be included in every submission.	Find	Missing DM dataset	Reject
SD1109	Exposure (EX) dataset should be included in every submission.	Find	Missing EX dataset
SD1110	Disposition (DS) dataset should be included in every submission.	Find	Missing DS dataset
SD1111	Subject Elements (SE) dataset should be included in every submission.	Find	Missing SE dataset
SD1112	Trial Arms (TA) dataset should be included in every submission.	Find	Missing TA dataset
SD1113	Trial Elements (TE) dataset should be included in every submission.	Find	Missing TE dataset
SD1115	Trial Summary (TS) dataset must be included in every submission.	Find	Missing TS dataset	Reject
SE0007	Trial Sets (TX) dataset should be included in every submission.	Find	Missing TX dataset
SE2246	Trial Repro Stages (TT) dataset should be included for nonclinical Developmental and Reproductive Toxicology (DART) studies.	Find	Missing TT dataset
SE2247	Trial Repro Paths (TP) dataset should be included for nonclinical Developmental and Reproductive Toxicology (DART) studies.	Find	Missing TP dataset
SE2248	Subject Repro Stages (SJ) dataset should be included for nonclinical Developmental and Reproductive Toxicology (DART) studies.	Find	Missing SJ dataset

Unrecognized

Dataset Structure
Variable	Description	Required	Data Type	Length

Validation Rules
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

Trial Arms

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message
CT2001	Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist
CT2002	Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist
CT2003	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT
CT2004	Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression%
CT2005	Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression%
CT2006	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression%
SD0001	Domain table should have at least one record.	Property	No records in data source
SD0002	Required variables (where Core attribute is 'Req') cannot be NULL for any records.	Required	NULL value in %Variable% variable marked as Required
SD0004	Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset.	Match	Inconsistent value for DOMAIN
SD0037	Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml.	Match	Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist
SD0054	Variables listed in the data definition document (define.xml) should be included in the dataset.	Find	Variable in define.xml is not present in the dataset
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
SD0067	Element Code (ETCD) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN').	Lookup	Invalid ETCD
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
SD1009	The value of Element Code (ETCD) should be no more than 8 characters in length.	Regex	Invalid value for ETCD
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
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
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

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message
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 Repro Paths

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
DOMAIN	Domain Abbreviation	text	200
RPATHCD	Planned Repro Path Code	text	200
RPATH	Description of Planned Repro Path	text	200
TPSTGORD	Order of Repro Stage within Repro Path	integer	200
RSTGCD	Repro Stage Code	text	200
RSTAGE	Description of Repro Stage	text	200
TPBRANCH	Branch	text	200
RPHASE	Repro Phase	text	200
RPRFDY	Repro Phase Start Reference Day	integer	200

Validation Rules
ID	Description	Validator	Message
CT2001	Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist
CT2002	Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist
CT2003	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT
CT2004	Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression%
CT2005	Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression%
CT2006	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression%
SD0001	Domain table should have at least one record.	Property	No records in data source
SD0002	Required variables (where Core attribute is 'Req') cannot be NULL for any records.	Required	NULL value in %Variable% variable marked as Required
SD0004	Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset.	Match	Inconsistent value for DOMAIN
SD0037	Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml.	Match	Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist
SD0054	Variables listed in the data definition document (define.xml) should be included in the dataset.	Find	Variable in define.xml is not present in the dataset
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
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
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
SE2252	The value of Repro Stage Code (RSTGCD) should be no more than 8 characters in length.	Regex	Invalid value for RSTGCD
SE2254	Description of Repro Stage (RSTAGE) must have a unique value for a given value of Repro Stage Code (RSTGCD) within the domain.	Unique	Non-unique value for RSTAGE within RSTGCD
SE2255	Repro Stage Code (RSTGCD) must have a unique value for a given value of Description of Repro Stage (RSTAGE) within the domain.	Unique	Non-unique value for RSTGCD within RSTAGE
SE2257	Order of Repro Stage within Repro Path (TPSTGORD) variable value must be an integer.	Regex	Invalid value for TPSTGORD
SE2258	Repro Stage Code (RSTGCD) values should match entries in the Trial Repro Stages (TT) dataset, except for an unplanned Repro Stage (RSTGCD = 'UNPLAN').	Lookup	Invalid RSTGCD
SE2259	The combination of Repro Stage Code (RSTGCD) and Description of Repro Stage (RSTAGE) values should match entries in the Trial Repro Stages (TT) dataset, except for an unplanned Repro Stage (RSTGCD = 'UNPLAN').	Lookup	Invalid RSTGCD/RSTAGE
SE2260	Repro Phase Start Reference Day (RPRFDY) must be 0 or 1 in the Trial Repro Paths (TP) dataset.	Match	Invalid value for RPRFDY
SE2261	The value of Planned Repro Path Code (RPATHCD) should be no more than 20 characters in length.	Regex	Invalid value for RPATHCD
SE2263	Order of Repro Stage within Repro Path (TPSTGORD) must have a unique value for a given value of Planned Repro Path Code (RPATHCD) within the Trial Repro Paths (TP) dataset.	Unique	Non-unique value for TPSTGORD within RPATHCD

Trial Summary

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message	Severity
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	Reject
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
SE2249	TSVAL variable value should be 'SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.1' for the SNDIGVER parameter in nonclinical Developmental and Reproductive Toxicology (DART) studies.	Condition	Invalid TSVAL value for SNDIGVER
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	Reject
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	Reject
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
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
SE2365	TSVAL/TXVAL value must be a positive integer when TSPARMCD/TXPARMCD = 'AGE'.	Condition	Invalid %Domain%VAL value for AGE

Trial Repro Stages

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
DOMAIN	Domain Abbreviation	text	200
RSTGCD	Repro Stage Code	text	200
RSTAGE	Description of Repro Stage	text	200
TTSTRL	Rule for Start of Repro Stage	text	200
TTENRL	Rule for End of Repro Stage	text	200
TTDUR	Planned Duration of Repro Stage	text	200

Validation Rules
ID	Description	Validator	Message
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
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
SD1021	Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables.	Regex	Unexpected character value in %Variable% variable
SD1063	Datasets included in study data must be described in the data definition document (define.xml).	Match	Dataset is not present in define.xml
SD1071	Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB.	Property	Dataset is greater than 5 GB in size
SD1073	Variables described in IG as inappropriate for usage must be not included in the dataset.	Find	Variable prohibited for use in SDTM
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
SE2252	The value of Repro Stage Code (RSTGCD) should be no more than 8 characters in length.	Regex	Invalid value for RSTGCD
SE2253	At least one of Rule for End of Repro Stage (TTENRL) or Planned Duration of Repro Stage (TTDUR) should be populated.	Condition	Missing values for TTENRL and TTDUR
SE2254	Description of Repro Stage (RSTAGE) must have a unique value for a given value of Repro Stage Code (RSTGCD) within the domain.	Unique	Non-unique value for RSTAGE within RSTGCD
SE2255	Repro Stage Code (RSTGCD) must have a unique value for a given value of Description of Repro Stage (RSTAGE) within the domain.	Unique	Non-unique value for RSTGCD within RSTAGE
SE2256	The combination of Description of Repro Stage (RSTAGE), Rule for Start of Repro Stage (TTSTRL), Rule for End of Repro Stage (TTENRL), and Planned Duration of Repro Stage (TTDUR) should be unique for each Repro Stage Code (RSTGCD).	Unique	The combination of RSTAGE, TTSTRL TTENRL, and TTDUR is not unique for each RSTGCD
SE2374	There should only be one record per planned stage in the Trial Repro Stages (TT) domain, therefore the value of Repro Stage Code (RSTGCD) variable must be unique within the domain.	Unique	Duplicate RSTGCD value

Trial Sets

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message
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
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
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
SE2365	TSVAL/TXVAL value must be a positive integer when TSPARMCD/TXPARMCD = 'AGE'.	Condition	Invalid %Domain%VAL value for AGE
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

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
DOMAIN	Domain Abbreviation	text	200
RDOMAIN	Related Domain Abbreviation	text	200
USUBJID	Unique Subject Identifier	text	200
POOLID	Pool Identifier	text	200
SPDEVID	Sponsor Device Identifier	text	200
NHOID	Non-Host Organism Identifier	text	200
FETUSID	Unique Fetus Identifier	text	200
FOCID	Focus of Study-Specific Interest	text	200
COSEQ	Sequence Number	float	200
COGRPID	Group ID	text	200
COREFID	Reference ID	text	200
COSPID	Sponsor-Defined Identifier	text	200
IDVAR	Identifying Variable	text	200
IDVARVAL	Identifying Variable Value	text	200
COREF	Comment Reference	text	200
COVAL	Comment	text	200
COVAL1	Comment 1	text	200
COVAL2	Comment 2	text	200
COVAL3	Comment 3	text	200
COVAL4	Comment 4	text	200
COVAL5	Comment 5	text	200
COVAL6	Comment 6	text	200
COVAL7	Comment 7	text	200
COVAL8	Comment 8	text	200
COVAL9	Comment 9	text	200
COVAL10	Comment 10	text	200
COEVAL	Evaluator	text	200
VISITDY	Planned Study Day of Collection	integer	200
TAETORD	Planned Order of Element within Arm	integer	200
RPHASE	Repro Phase	text	200
CODTC	Date/Time of Comment	datetime	200
CODY	Study Day of Comment	integer	200
CORPDY	Actual Repro Phase Day of Observation	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

Validation Rules
ID	Description	Validator	Message
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Demographics

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
DOMAIN	Domain Abbreviation	text	200
USUBJID	Unique Subject Identifier	text	200
SUBJID	Subject Identifier for the Study	text	200
RFSTDTC	Subject Reference Start Date/Time	datetime	200
RFENDTC	Subject Reference End Date/Time	datetime	200
RFXSTDTC	Date/Time of First Study Treatment	datetime	200
RFXENDTC	Date/Time of Last Study Treatment	datetime	200
RFICDTC	Date/Time of Informed Consent	datetime	200
RFPENDTC	Date/Time of End of Participation	datetime	200
DTHDTC	Date/Time of Death	datetime	200
DTHFL	Subject Death Flag	text	200
SITEID	Study Site Identifier	text	200
INVID	Investigator Identifier	text	200
INVNAM	Investigator Name	text	200
BRTHDTC	Date/Time of Birth	datetime	200
AGE	Age	integer	200
AGETXT	Age Range	text	200
AGEU	Age 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
RPATHCD	Planned Repro Path 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

Validation Rules
ID	Description	Validator	Message
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
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
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2261	The value of Planned Repro Path Code (RPATHCD) should be no more than 20 characters in length.	Regex	Invalid value for RPATHCD
SE2262	Repro Path Code (RPATHCD) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPATHCD
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
SE2359	The Planned Repro Path Code (RPATHCD) variable in the Demographics (DM) domain is required to be populated when the Trial Repro Paths (TP) domain is provided, and TP is a required domain for this standard.	Required	DM.RPATHCD is not provided
SE2364	The value of Age (AGE) cannot be less than 0.	Condition	Negative value for AGE
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Subject Elements

Dataset Structure
Variable	Description	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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
SERPDY	Actual Repro Phase Day of Observation	integer	200
SERPSTDY	Actual Repro Phase Day of Obs Start	integer	200
SERPENDY	Actual Repro Phase Day of Obs End	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
SEUPDES	Description of Unplanned Element	text	200

Validation Rules
ID	Description	Validator	Message
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2357	In the Subject Elements (SE) domain, for each subject, each Element should have a different start date.	Unique	Duplicate SESTDTC within USUBJID
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Subject Repro Stages

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
DOMAIN	Domain Abbreviation	text	200
USUBJID	Unique Subject Identifier	text	200
SJSEQ	Sequence Number	float	200
SJGRPID	Group ID	text	200
SJREFID	Reference ID	text	200
SJSPID	Sponsor-Defined Identifier	text	200
RSTGCD	Repro Stage Code	text	200
RSTAGE	Description of Repro Stage	text	200
SJSTDTC	Start Date/Time of Repro Stage	datetime	200
SJENDTC	End Date/Time of Repro Stage	datetime	200
TAETORD	Planned Order of Element within Arm	integer	200
EPOCH	Epoch	text	200
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	200
SJDTC	Date/Time of Collection	datetime	200
SJSTDY	Study Day of Start of Element	integer	200
SJENDY	Study Day of End of Element	integer	200
SJDY	Study Day of Visit/Collection/Exam	integer	200
SJDUR	Duration	text	200
SJTPT	Planned Time Point Name	text	200
SJTPTNUM	Planned Time Point Number	float	200
SJELTM	Planned Elapsed Time from Time Point Ref	text	200
SJTPTREF	Time Point Reference	text	200
SJRFTDTC	Date/Time of Reference Time Point	datetime	200
SJUPDES	Description of Repro Stage	text	200

Validation Rules
ID	Description	Validator	Message
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
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
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
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2250	Description of Repro Stage (RSTAGE) should be NULL when subject's experience for a particular period of time is represented as an unplanned Repro Stage, where Repro Stage Code (RSTGCD) is equal to 'UNPLAN'.	Condition	RSTAGE value is populated when RSTGCD = 'UNPLAN'
SE2251	Description of Repro Stage (SJUPDES) should be populated when a subject's experience for a particular period of time is represented as an unplanned Repro Stage, where Repro Stage Code (RSTGCD) is equal to 'UNPLAN'.	Condition	Missing value for SJUPDES when RSTGCD='UNPLAN'
SE2252	The value of Repro Stage Code (RSTGCD) should be no more than 8 characters in length.	Regex	Invalid value for RSTGCD
SE2254	Description of Repro Stage (RSTAGE) must have a unique value for a given value of Repro Stage Code (RSTGCD) within the domain.	Unique	Non-unique value for RSTAGE within RSTGCD
SE2255	Repro Stage Code (RSTGCD) must have a unique value for a given value of Description of Repro Stage (RSTAGE) within the domain.	Unique	Non-unique value for RSTGCD within RSTAGE
SE2258	Repro Stage Code (RSTGCD) values should match entries in the Trial Repro Stages (TT) dataset, except for an unplanned Repro Stage (RSTGCD = 'UNPLAN').	Lookup	Invalid RSTGCD
SE2259	The combination of Repro Stage Code (RSTGCD) and Description of Repro Stage (RSTAGE) values should match entries in the Trial Repro Stages (TT) dataset, except for an unplanned Repro Stage (RSTGCD = 'UNPLAN').	Lookup	Invalid RSTGCD/RSTAGE
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE

Interventions

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
__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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
__RPDY	Actual Repro Phase Day of Observation	integer	200
__RPSTDY	Actual Repro Phase Day of Obs Start	integer	200
__RPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Exposure

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
EXRPDY	Actual Repro Phase Day of Observation	integer	200
EXRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
EXRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
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
SD0082	End Date/Time of Treatment (EXENDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). Investigator should provide a date of study discontinuation for each subject in Disposition (DS) domain.	Condition	Exposure end date is after the latest Disposition date
SD1005	Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain.	Lookup	Invalid STUDYID
SD1011	Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT, --STINT, --ENINT, TDSTOFF, TDTGTPAI, TDMINPAI, TDMAXPAI) must conform to the ISO 8601 international standard.	Regex	Invalid ISO 8601 value for %Variable% variable
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
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
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
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
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
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
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
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
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
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
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Events

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
__RPDY	Actual Repro Phase Day of Observation	integer	200
__RPSTDY	Actual Repro Phase Day of Obs Start	integer	200
__RPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
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
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Disposition

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
DSRPDY	Actual Repro Phase Day of Observation	integer	200
DSRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
DSRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2362	At least one of the these variables or sets of variables should be populated in DS: RPPLSTDY or --RPSTDY. 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: RPPLSTDY or %Domain%RPSTDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Findings

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
__RESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
__RPDY	Actual Repro Phase Day of Observation	integer	200
__RPSTDY	Actual Repro Phase Day of Obs Start	integer	200
__RPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Body Weight Gains

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
BGRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
BGRPDY	Actual Repro Phase Day of Observation	integer	200
BGRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
BGRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
SD1101	End Reference Time Point (--ENTPT) variable must be included into the domain when End Relative to Reference Time Point (--ENRTPT) variable is present.	Find	Missing %Domain%ENTPT variable when %Domain%ENRTPT variable is present
SD1102	End Relative to Reference Time Point (--ENRTPT) variable must be included into the domain when End Relative Time Point (--ENTPT) variable is present.	Find	Missing %Domain%ENRTPT variable when %Domain%ENTPT variable is present
SD1103	Start Reference Time Point (--STTPT) variable must be included into the domain when Start Relative to Reference Time Point (--STRTPT) variable is present.	Find	Missing %Domain%STTPT variable when %Domain%STRTPT variable is present
SD1104	Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain when Start Relative Time Point (--STTPT) variable is present.	Find	Missing %Domain%STRTPT variable when %Domain%STTPT variable is present
SD1116	Split datasets should have matching variable lengths for future mergers. Datasets should be resized to the maximum length used prior to splitting.	Unique	Inconsistent variable length within split datasets
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2363	These variables must be populated: --RPDY and --RPENDY. 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%RPDY & %Domain%RPENDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Body Weight

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
BWRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
BWRPDY	Actual Repro Phase Day of Observation	integer	200
BWRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
BWRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Clinical Observations

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
CLRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
CLRPDY	Actual Repro Phase Day of Observation	integer	200
CLRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
CLRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
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')
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Cardiovascular Test Results

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
CVRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
CVRPDY	Actual Repro Phase Day of Observation	integer	200
CVRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
CVRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Death Diagnosis and Details

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
DDRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
DDRPDY	Actual Repro Phase Day of Observation	integer	200
DDRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
DDRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

ECG Test Results

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
EGRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
EGRPDY	Actual Repro Phase Day of Observation	integer	200
EGRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
EGRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Fetal Measurements

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism Identifier	text	200
FETUSID	Unique Fetus Identifier	text	200
FOCID	Focus of Study-Specific Interest	text	200
FMSEQ	Sequence Number	float	200
FMGRPID	Group Identifier	text	200
FMREFID	Reference ID	text	200
FMRECID	Invariant Record Identifier	text	200
FMSPID	Sponsor-Defined Identifier	text	200
FMLNKID	Link ID	text	200
FMLNKGRP	Link Group ID	text	200
FMTESTCD	Test Short Name	text	200
FMTEST	Fetal Measurement Name	text	200
FMMODIFY	Modified Term	text	200
FMTSTDTL	Measurement, Test or Examination Detail	text	200
FMCAT	Category	text	200
FMSCAT	Subcategory	text	200
FMPOS	Position of Subject During Observation	text	200
FMBODSYS	Body System or Organ Class	text	200
FMORRES	Result or Findings as Collected	text	200
FMORRESU	Unit of the Original Result	text	200
FMORNRLO	Normal Range Lower Limit-Original Units	text	200
FMORNRHI	Normal Range Upper Limit-Original Units	text	200
FMORREF	Reference Result in Original Units	text	200
FMSTRESC	Standardized Results in Character Format	text	200
FMSTRESN	Standardized Results in Numeric Format	float	200
FMSTRESU	Unit of the Standardized Result	text	200
FMSTNRLO	Normal Range Lower Limit-Standard Units	float	200
FMSTNRHI	Normal Range Upper Limit-Standard Units	float	200
FMSTNRC	Normal Range for Character Results	text	200
FMSTREFC	Reference Result in Standard Format	text	200
FMSTREFN	Numeric Reference Result in Std Units	float	200
FMNRIND	Normal/Reference Range Indicator	text	200
FMRESCAT	Result Category	text	200
FMCHRON	Chronicity of Finding	text	200
FMDISTR	Distribution Pattern of Finding	text	200
FMRESLOC	Result Location of Finding	text	200
FMSTAT	Completion Status	text	200
FMREASND	Reason Not Done	text	200
FMXFN	External File Path	text	200
FMNAM	Laboratory/Vendor Name	text	200
FMLOINC	LOINC Code	text	200
FMSPEC	Specimen Material Type	text	200
FMANTREG	Anatomical Region	text	200
FMSPCCND	Specimen Condition	text	200
FMSPCUFL	Specimen Usability for the Test	text	200
FMLOC	Location Used for the Measurement	text	200
FMLAT	Laterality	text	200
FMDIR	Directionality	text	200
FMPORTOT	Portion or Totality	text	200
FMMETHOD	Method of Test or Examination	text	200
FMRUNID	Run ID	text	200
FMANMETH	Analysis Method	text	200
FMLEAD	Lead Identified to Collect Measurements	text	200
FMCSTATE	Consciousness State	text	200
FMLOBXFL	Last Observation Before Exposure Flag	text	200
FMBLFL	Baseline Flag	text	200
FMFAST	Fasting Status	text	200
FMDRVFL	Derived Flag	text	200
FMEVAL	Evaluator	text	200
FMEVALID	Evaluator Identifier	text	200
FMACPTFL	Accepted Record Flag	text	200
FMTOX	Toxicity	text	200
FMTOXGR	Toxicity Grade	text	200
FMSEV	Severity	text	200
FMDTHREL	Relationship to Death	text	200
FMLLOQ	Lower Limit of Quantitation	float	200
FMULOQ	Upper Limit of Quantitation	float	200
FMEXCLFL	Exclusion Flag	text	200
FMREASEX	Reason for Exclusion	text	200
FMUSCHFL	Unscheduled Flag	text	200
FMREPNUM	Repetition Number	float	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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	200
FMDTC	Date/Time	datetime	200
FMSTDTC	Start Date/Time of Observation	datetime	200
FMENDTC	End Date/Time of Observation	datetime	200
FMDY	Study Day	integer	200
FMSTDY	Study Day of Start of Observation	integer	200
FMENDY	Study Day of End of Observation	integer	200
FMNOMDY	Nominal Study Day for Tabulations	integer	200
FMNOMLBL	Label for Nominal Study Day	text	200
FMRPDY	Actual Repro Phase Day	integer	200
FMRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
FMRPENDY	Actual Repro Phase Day of Obs End	integer	200
FMDUR	Duration	text	200
FMTPT	Planned Time Point Name	text	200
FMTPTNUM	Planned Time Point Number	float	200
FMELTM	Planned Elapsed Time from Time Point Ref	text	200
FMTPTREF	Time Point Reference	text	200
FMRFTDTC	Date/Time of Reference Time Point	datetime	200
FMSTRF	Start Relative to Reference Period	text	200
FMENRF	End Relative to Reference Period	text	200
FMEVLINT	Evaluation Interval	text	200
FMEVINTX	Evaluation Interval Text	text	200
FMSTRTPT	Start Relative to Reference Time Point	text	200
FMSTTPT	Start Reference Time Point	text	200
FMENRTPT	End Relative to Reference Time Point	text	200
FMENTPT	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
FMSTINT	Planned Start of Assessment Interval	datetime	200
FMENINT	Planned End of Assessment Interval	datetime	200
FMDETECT	Time in Days to Detection	integer	200

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2358	The combination of USUBJID/FETUSID in the Fetal Measurements (FM) and Fetal Pathology Findings (FX) domains should be consistent with the Implantation Classification (IC) domain.	Lookup	The combination of USUBJID and FETUSID value does not exist in the IC domain
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2376	The Implantation Classification (IC), Fetal Measurements (FM), and Fetal Pathology Findings (FX) domains should only include records for pregnant females, therefore subjects in these domains should have a corresponding record in the Nonclinical Pregnancy Results (PY) domain with Test Short Name (PYTESTCD) = 'PREGSTAT' and Result Category (PYRESCAT) = 'PREGNANCY'.	Lookup	Subject does not have a record in PY indicating subject is pregnant
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Food and Water Consumption

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
FWRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
FWRPDY	Actual Repro Phase Day of Observation	integer	200
FWRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
FWRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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'
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2363	These variables must be populated: --RPDY and --RPENDY. 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%RPDY & %Domain%RPENDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Fetal Pathology Findings

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism Identifier	text	200
FETUSID	Unique Fetus Identifier	text	200
FOCID	Focus of Study-Specific Interest	text	200
FXSEQ	Sequence Number	float	200
FXGRPID	Group Identifier	text	200
FXREFID	Reference ID	text	200
FXRECID	Invariant Record Identifier	text	200
FXSPID	Sponsor-Defined Identifier	text	200
FXLNKID	Link ID	text	200
FXLNKGRP	Link Group ID	text	200
FXTESTCD	Test Short Name	text	200
FXTEST	Fetal Exam Name	text	200
FXMODIFY	Modified Term	text	200
FXTSTDTL	Measurement, Test or Examination Detail	text	200
FXCAT	Category	text	200
FXSCAT	Subcategory	text	200
FXPOS	Position of Subject During Observation	text	200
FXBODSYS	Body System or Organ Class	text	200
FXORRES	Result or Findings as Collected	text	200
FXORRESU	Unit of the Original Result	text	200
FXORNRLO	Normal Range Lower Limit-Original Units	text	200
FXORNRHI	Normal Range Upper Limit-Original Units	text	200
FXORREF	Reference Result in Original Units	text	200
FXSTRESC	Standardized Results in Character Format	text	200
FXSTRESN	Standardized Result in Numeric Format	float	200
FXSTRESU	Unit of the Standardized Result	text	200
FXSTNRLO	Normal Range Lower Limit-Standard Units	float	200
FXSTNRHI	Normal Range Upper Limit-Standard Units	float	200
FXSTNRC	Normal Range for Character Results	text	200
FXSTREFC	Reference Result in Standard Format	text	200
FXSTREFN	Numeric Reference Result in Std Units	float	200
FXNRIND	Normal/Reference Range Indicator	text	200
FXRESCAT	Result Category	text	200
FXCHRON	Chronicity of Finding	text	200
FXDISTR	Distribution Pattern of Finding	text	200
FXRESLOC	Result Location of Finding	text	200
FXSTAT	Completion Status	text	200
FXREASND	Reason Not Done	text	200
FXXFN	External File Path	text	200
FXNAM	Laboratory/Vendor Name	text	200
FXLOINC	LOINC Code	text	200
FXSPEC	Specimen Material Type	text	200
FXANTREG	Anatomical Region	text	200
FXSPCCND	Specimen Condition	text	200
FXSPCUFL	Specimen Usability for the Test	text	200
FXLOC	Location Used for the Measurement	text	200
FXLAT	Laterality	text	200
FXDIR	Directionality	text	200
FXPORTOT	Portion or Totality	text	200
FXMETHOD	Method of Test or Examination	text	200
FXRUNID	Run ID	text	200
FXANMETH	Analysis Method	text	200
FXLEAD	Lead Identified to Collect Measurements	text	200
FXCSTATE	Consciousness State	text	200
FXLOBXFL	Last Observation Before Exposure Flag	text	200
FXBLFL	Baseline Flag	text	200
FXFAST	Fasting Status	text	200
FXDRVFL	Derived Flag	text	200
FXEVAL	Evaluator	text	200
FXEVALID	Evaluator Identifier	text	200
FXACPTFL	Accepted Record Flag	text	200
FXTOX	Toxicity	text	200
FXTOXGR	Toxicity Grade	text	200
FXSEV	Severity	text	200
FXDTHREL	Relationship to Death	text	200
FXLLOQ	Lower Limit of Quantitation	float	200
FXULOQ	Upper Limit of Quantitation	float	200
FXEXCLFL	Exclusion Flag	text	200
FXREASEX	Reason for Exclusion	text	200
FXUSCHFL	Unscheduled Flag	text	200
FXREPNUM	Repetition Number	float	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
RPHASE	Reproductive Phase	text	200
RPPLDY	Planned Phase Day	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	200
FXDTC	Date/Time	datetime	200
FXSTDTC	Start Date/Time of Observation	datetime	200
FXENDTC	End Date/Time of Observation	datetime	200
FXDY	Study Day	integer	200
FXSTDY	Study Day of Start of Observation	integer	200
FXENDY	Study Day of End of Observation	integer	200
FXNOMDY	Nominal Study Day for Tabulations	integer	200
FXNOMLBL	Label for Nominal Study Day	text	200
FXRPDY	Actual Phase Day	integer	200
FXRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
FXRPENDY	Actual Repro Phase Day of Obs End	integer	200
FXDUR	Duration	text	200
FXTPT	Planned Time Point Name	text	200
FXTPTNUM	Planned Time Point Number	float	200
FXELTM	Planned Elapsed Time from Time Point Ref	text	200
FXTPTREF	Time Point Reference	text	200
FXRFTDTC	Date/Time of Reference Time Point	datetime	200
FXSTRF	Start Relative to Reference Period	text	200
FXENRF	End Relative to Reference Period	text	200
FXEVLINT	Evaluation Interval	text	200
FXEVINTX	Evaluation Interval Text	text	200
FXSTRTPT	Start Relative to Reference Time Point	text	200
FXSTTPT	Start Reference Time Point	text	200
FXENRTPT	End Relative to Reference Time Point	text	200
FXENTPT	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
FXSTINT	Planned Start of Assessment Interval	datetime	200
FXENINT	Planned End of Assessment Interval	datetime	200
FXDETECT	Time in Days to Detection	integer	200

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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')
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')
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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'
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2358	The combination of USUBJID/FETUSID in the Fetal Measurements (FM) and Fetal Pathology Findings (FX) domains should be consistent with the Implantation Classification (IC) domain.	Lookup	The combination of USUBJID and FETUSID value does not exist in the IC domain
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2376	The Implantation Classification (IC), Fetal Measurements (FM), and Fetal Pathology Findings (FX) domains should only include records for pregnant females, therefore subjects in these domains should have a corresponding record in the Nonclinical Pregnancy Results (PY) domain with Test Short Name (PYTESTCD) = 'PREGSTAT' and Result Category (PYRESCAT) = 'PREGNANCY'.	Lookup	Subject does not have a record in PY indicating subject is pregnant
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Implantation Classification

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism Identifier	text	200
FETUSID	Unique Fetus Identifier	text	200
FOCID	Focus of Study-Specific Interest	text	200
ICSEQ	Sequence Number	float	200
ICGRPID	Group Identifier	text	200
ICREFID	Reference ID	text	200
ICRECID	Invariant Record Identifier	text	200
ICSPID	Sponsor-Defined Identifier	text	200
ICLNKID	Link ID	text	200
ICLNKGRP	Link Group ID	text	200
ICTESTCD	Test Short Name	text	200
ICTEST	Implantation Exam Name	text	200
ICMODIFY	Modified Term	text	200
ICTSTDTL	Measurement, Test or Examination Detail	text	200
ICCAT	Category	text	200
ICSCAT	Subcategory	text	200
ICPOS	Position of Subject During Observation	text	200
ICBODSYS	Body System or Organ Class	text	200
ICORRES	Result or Findings as Collected	text	200
ICORRESU	Unit of the Original Result	text	200
ICORNRLO	Normal Range Lower Limit-Original Units	text	200
ICORNRHI	Normal Range Upper Limit-Original Units	text	200
ICORREF	Reference Result in Original Units	text	200
ICSTRESC	Standardized Results in Character Format	text	200
ICIMPLBL	Implantation Site Label	text	200
ICSTRESN	Standardized Result in Numeric Format	float	200
ICSTRESU	Unit of the Standardized Result	text	200
ICSTNRLO	Normal Range Lower Limit-Standard Units	float	200
ICSTNRHI	Normal Range Upper Limit-Standard Units	float	200
ICSTNRC	Normal Range for Character Results	text	200
ICSTREFC	Reference Result in Standard Format	text	200
ICSTREFN	Numeric Reference Result in Std Units	float	200
ICNRIND	Normal/Reference Range Indicator	text	200
ICRESCAT	Result Category	text	200
ICCHRON	Chronicity of Finding	text	200
ICDISTR	Distribution Pattern of Finding	text	200
ICRESLOC	Result Location of Finding	text	200
ICSTAT	Completion Status	text	200
ICREASND	Reason Not Done	text	200
ICXFN	External File Path	text	200
ICNAM	Laboratory/Vendor Name	text	200
ICLOINC	LOINC Code	text	200
ICSPEC	Specimen Material Type	text	200
ICANTREG	Anatomical Region	text	200
ICSPCCND	Specimen Condition	text	200
ICSPCUFL	Specimen Usability for the Test	text	200
ICLOC	Location Used for the Measurement	text	200
ICLAT	Laterality	text	200
ICDIR	Directionality	text	200
ICPORTOT	Portion or Totality	text	200
ICMETHOD	Method of Test or Examination	text	200
ICRUNID	Run ID	text	200
ICANMETH	Analysis Method	text	200
ICLEAD	Lead Identified to Collect Measurements	text	200
ICCSTATE	Consciousness State	text	200
ICLOBXFL	Last Observation Before Exposure Flag	text	200
ICBLFL	Baseline Flag	text	200
ICFAST	Fasting Status	text	200
ICDRVFL	Derived Flag	text	200
ICEVAL	Evaluator	text	200
ICEVALID	Evaluator Identifier	text	200
ICACPTFL	Accepted Record Flag	text	200
ICTOX	Toxicity	text	200
ICTOXGR	Toxicity Grade	text	200
ICSEV	Severity	text	200
ICDTHREL	Relationship to Death	text	200
ICLLOQ	Lower Limit of Quantitation	float	200
ICULOQ	Upper Limit of Quantitation	float	200
ICEXCLFL	Exclusion Flag	text	200
ICREASEX	Reason for Exclusion	text	200
ICUSCHFL	Unscheduled Flag	text	200
ICREPNUM	Repetition Number	float	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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	200
ICDTC	Date/Time	datetime	200
ICSTDTC	Start Date/Time of Observation	datetime	200
ICENDTC	End Date/Time of Observation	datetime	200
ICDY	Study Day	integer	200
ICSTDY	Study Day of Start of Observation	integer	200
ICENDY	Study Day of End of Observation	integer	200
ICNOMDY	Nominal Study Day for Tabulations	integer	200
ICNOMLBL	Label for Nominal Study Day	text	200
ICRPDY	Actual Repro Phase Day of Observation	integer	200
ICRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
ICRPENDY	Actual Repro Phase Day of Obs End	integer	200
ICDUR	Duration	text	200
ICTPT	Planned Time Point Name	text	200
ICTPTNUM	Planned Time Point Number	float	200
ICELTM	Planned Elapsed Time from Time Point Ref	text	200
ICTPTREF	Time Point Reference	text	200
ICRFTDTC	Date/Time of Reference Time Point	datetime	200
ICSTRF	Start Relative to Reference Period	text	200
ICENRF	End Relative to Reference Period	text	200
ICEVLINT	Evaluation Interval	text	200
ICEVINTX	Evaluation Interval Text	text	200
ICSTRTPT	Start Relative to Reference Time Point	text	200
ICSTTPT	Start Reference Time Point	text	200
ICENRTPT	End Relative to Reference Time Point	text	200
ICENTPT	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
ICSTINT	Planned Start of Assessment Interval	datetime	200
ICENINT	Planned End of Assessment Interval	datetime	200
ICDETECT	Time in Days to Detection	integer	200

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2372	The value for Fetus Identifier (FETUSID) must be unique per subject within a study.	Unique	Non-unique value for FETUSID within USUBJID
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2376	The Implantation Classification (IC), Fetal Measurements (FM), and Fetal Pathology Findings (FX) domains should only include records for pregnant females, therefore subjects in these domains should have a corresponding record in the Nonclinical Pregnancy Results (PY) domain with Test Short Name (PYTESTCD) = 'PREGSTAT' and Result Category (PYRESCAT) = 'PREGNANCY'.	Lookup	Subject does not have a record in PY indicating subject is pregnant
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Laboratory

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
LBRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
LBRPDY	Actual Repro Phase Day of Observation	integer	200
LBRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
LBRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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'
SD1124	Value of Reason Not Done (--REASND) variable should be populated when Status (--STAT) variable value is 'NOT DONE'.	Condition	Missing value for %Domain%REASND 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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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'
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Macroscopic Findings

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
MARESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
MARPDY	Actual Repro Phase Day of Observation	integer	200
MARPSTDY	Actual Repro Phase Day of Obs Start	integer	200
MARPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
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')
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Microscopic Findings

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
MIRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
MIRPDY	Actual Repro Phase Day of Observation	integer	200
MIRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
MIRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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'
SD1124	Value of Reason Not Done (--REASND) variable should be populated when Status (--STAT) variable value is 'NOT DONE'.	Condition	Missing value for %Domain%REASND 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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
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')
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Organ Measurements

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
OMRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
OMRPDY	Actual Repro Phase Day of Observation	integer	200
OMRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
OMRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Pharmacokinetic Concentrations

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
PCRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
PCRPDY	Actual Repro Phase Day of Observation	integer	200
PCRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
PCRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Palpable Masses

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
PMRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
PMRPDY	Actual Repro Phase Day of Observation	integer	200
PMRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
PMRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Pharmacokinetic Parameters

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
PPRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
PPRPDY	Actual Repro Phase Day of Observation	integer	200
PPRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
PPRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Nonclinical Pregnancy Results

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism Identifier	text	200
FETUSID	Fetus Identifier	text	200
FOCID	Focus of Study-Specific Interest	text	200
PYSEQ	Sequence Number	float	200
PYGRPID	Group Identifier	text	200
PYREFID	Reference ID	text	200
PYRECID	Invariant Record Identifier	text	200
PYSPID	Sponsor-Defined Identifier	text	200
PYLNKID	Link ID	text	200
PYLNKGRP	Link Group ID	text	200
PYTESTCD	Test Short Name	text	200
PYTEST	Pregnancy Result Test Name	text	200
PYMODIFY	Modified Term	text	200
PYTSTDTL	Measurement, Test or Examination Detail	text	200
PYCAT	Category	text	200
PYSCAT	Subcategory	text	200
PYPOS	Position of Subject During Observation	text	200
PYBODSYS	Body System or Organ Class	text	200
PYORRES	Result or Findings as Collected	text	200
PYORRESU	Unit of the Original Result	text	200
PYORNRLO	Normal Range Lower Limit-Original Units	text	200
PYORNRHI	Normal Range Upper Limit-Original Units	text	200
PYORREF	Reference Result in Original Units	text	200
PYSTRESC	Standardized Results in Character Format	text	200
PYSTRESN	Standardized Results in Numeric Format	float	200
PYSTRESU	Unit of the Standardized Result	text	200
PYSTNRLO	Normal Range Lower Limit-Standard Units	float	200
PYSTNRHI	Normal Range Upper Limit-Standard Units	float	200
PYSTNRC	Normal Range for Character Results	text	200
PYSTREFC	Reference Result in Standard Format	text	200
PYSTREFN	Numeric Reference Result in Std Units	float	200
PYNRIND	Normal/Reference Range Indicator	text	200
PYRESCAT	Result Category	text	200
PYCHRON	Chronicity of Finding	text	200
PYDISTR	Distribution Pattern of Finding	text	200
PYRESLOC	Result Location of Finding	text	200
PYSTAT	Completion Status	text	200
PYREASND	Reason Not Done	text	200
PYXFN	External File Path	text	200
PYNAM	Laboratory/Vendor Name	text	200
PYLOINC	LOINC Code	text	200
PYSPEC	Specimen Material Type	text	200
PYANTREG	Anatomical Region	text	200
PYSPCCND	Specimen Condition	text	200
PYSPCUFL	Specimen Usability for the Test	text	200
PYLOC	Location Used for the Measurement	text	200
PYLAT	Laterality	text	200
PYDIR	Directionality	text	200
PYPORTOT	Portion or Totality	text	200
PYMETHOD	Method of Test or Examination	text	200
PYRUNID	Run ID	text	200
PYANMETH	Analysis Method	text	200
PYLEAD	Lead Identified to Collect Measurements	text	200
PYCSTATE	Consciousness State	text	200
PYLOBXFL	Last Observation Before Exposure Flag	text	200
PYBLFL	Baseline Flag	text	200
PYFAST	Fasting Status	text	200
PYDRVFL	Derived Flag	text	200
PYEVAL	Evaluator	text	200
PYEVALID	Evaluator Identifier	text	200
PYACPTFL	Accepted Record Flag	text	200
PYTOX	Toxicity	text	200
PYTOXGR	Toxicity Grade	text	200
PYSEV	Severity	text	200
PYDTHREL	Relationship to Death	text	200
PYLLOQ	Lower Limit of Quantitation	float	200
PYULOQ	Upper Limit of Quantitation	float	200
PYEXCLFL	Exclude from Statistics	text	200
PYREASEX	Reason for Exclusion from Statistics	text	200
PYUSCHFL	Unscheduled Flag	text	200
PYREPNUM	Repetition Number	float	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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	200
PYDTC	Date/Time	datetime	200
PYSTDTC	Start Date/Time of Observation	datetime	200
PYENDTC	End Date/Time of Observation	datetime	200
PYDY	Study Day	integer	200
PYSTDY	Study Day of Start of Observation	integer	200
PYENDY	Study Day of End of Observation	integer	200
PYNOMDY	Nominal Study Day for Tabulations	integer	200
PYNOMLBL	Label for Nominal Study Day	text	200
PYRPDY	Actual Repro Phase Day	integer	200
PYRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
PYRPENDY	Actual Repro Phase Day of Obs End	integer	200
PYDUR	Duration	text	200
PYTPT	Planned Time Point Name	text	200
PYTPTNUM	Planned Time Point Number	float	200
PYELTM	Planned Elapsed Time from Time Point Ref	text	200
PYTPTREF	Time Point Reference	text	200
PYRFTDTC	Date/Time of Reference Point	datetime	200
PYSTRF	Start Relative to Reference Period	text	200
PYENRF	End Relative to Reference Period	text	200
PYEVLINT	Evaluation Interval	text	200
PYEVINTX	Evaluation Interval Text	text	200
PYSTRTPT	Start Relative to Reference Time Point	text	200
PYSTTPT	Start Reference Time Point	text	200
PYENRTPT	End Relative to Reference Time Point	text	200
PYENTPT	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
PYSTINT	Start of Assessment Interval	text	200
PYENINT	End of Assessment Interval	text	200
PYDETECT	Time in Days to Detection	integer	200

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
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
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Respiratory Test Results

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
RERESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
RERPDY	Actual Repro Phase Day of Observation	integer	200
RERPSTDY	Actual Repro Phase Day of Obs Start	integer	200
RERPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Subject Characteristics

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
SCRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
SCRPDY	Actual Repro Phase Day of Observation	integer	200
SCRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
SCRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Tumor Findings

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
TFRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
TFRPDY	Actual Repro Phase Day of Observation	integer	200
TFRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
TFRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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'
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Vital Signs

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
VSRESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
VSRPDY	Actual Repro Phase Day of Observation	integer	200
VSRPSTDY	Actual Repro Phase Day of Obs Start	integer	200
VSRPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
SD1084	Collection Study Day (--DY) variable value should be populated when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%DY variable value is not populated
SD1085	Collection Study Day (--DY) variable value should not be imputed. It may be only populated when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both include complete date part.	Condition	%Domain%DY variable value is imputed
SD1086	Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%DY variable
SD1088	Study Day of Start (--STDY) variable value should be populated when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is not populated
SD1089	Study Day of Start (--STDY) variable value should not be imputed. It may be only populated when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%STDY variable value is imputed
SD1090	Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%STDY variable
SD1092	Study Day of End (--ENDY) variable value should be populated when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is not populated
SD1093	Study Day of End (--ENDY) variable value should not be imputed. It may be only populated when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both include complete date part.	Condition	%Domain%ENDY variable value is imputed
SD1094	Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC.	Condition	Incorrect value for %Domain%ENDY variable
SD1095	Split datasets must not have the name of original domain. E.g., lbhm.xpt is a valid name when lb.xpt is not a valid dataset name for split domain.	Find	Invalid dataset name for split domain
SD1098	Value for Category (--CAT) variable should be populated when value for Subcategory (--SCAT) variable is populated.	Condition	Missing %Domain%CAT value when %Domain%SCAT value is populated
SD1099	Category (--CAT) variable should be included into dataset when Subcategory (--SCAT) variable is present.	Find	Missing %Domain%CAT variable when %Domain%SCAT variable is present
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are provided
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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2361	At least one of the these variables or sets of variables should be populated: RPPLDY, or --RPDY. 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: RPPLDY or %Domain%RPDY
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2375	Actual Repro Phase Day of Obs End (--RPENDY) or Study Day of End of Observation (--ENDY) variable should be included into dataset, when End Date/Time of Observation (--ENDTC) variable is present.	Find	Missing %Domain%RPENDY or %Domain%ENDY variable, when %Domain%ENDTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Findings About Events or Interventions

Dataset Structure
Variable	Description	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
NHOID	Non-Host Organism 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
__RESLOC	Result Location 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
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
RPHASE	Repro Phase	text	200
RPPLDY	Planned Repro Phase Day of Observation	integer	200
RPPLSTDY	Planned Repro Phase Day of Obs Start	integer	200
RPPLENDY	Planned Repro Phase Day of Obs End	integer	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
__RPDY	Actual Repro Phase Day of Observation	integer	200
__RPSTDY	Actual Repro Phase Day of Obs Start	integer	200
__RPENDY	Actual Repro Phase Day of Obs End	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

Validation Rules
ID	Description	Validator	Message
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
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
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
SE2264	Repro Phase (RPHASE) is required to be populated when any Repro Phase timing variable is populated: Planned Repro Phase Day of Observation (RPPLDY), Planned Repro Phase Day of Obs Start (RPPLSTDY), Planned Repro Phase Day of Obs End (RPPLENDY), Actual Repro Phase Day of Observation (--RPDY), Actual Repro Phase Day of Obs Start (--RPSTDY), Actual Repro Phase Day of Obs End (--RPENDY).	Condition	Missing value for RPHASE when Repro Phase Day values are 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
SE2356	Repro Phase (RPHASE) values should match entries in the Trial Repro Paths (TP) dataset.	Lookup	Invalid RPHASE
SE2373	Actual Repro Phase Day (--RPDY) or Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present.	Find	Missing %Domain%RPDY or %Domain%DY variable, when %Domain%DTC variable is present
SE2377	Actual Repro Phase Day of Obs Start (--RPSTDY) or Study Day of Start of Observation (--STDY) variable should be included into dataset, when Start Date/Time of Observation (--STDTC) variable is present.	Find	Missing %Domain%RPSTDY or %Domain%STDY variable, when %Domain%STDTC variable is present

Pool Definition

Dataset Structure
Variable	Description	Data Type	Length
STUDYID	Study Identifier	text	200
POOLID	Pool Identifier	text	200
USUBJID	Unique Subject Identifier	text	200

Validation Rules
ID	Description	Validator	Message
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

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message
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

Dataset Structure
Variable	Description	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

Validation Rules
ID	Description	Validator	Message
CT2001	Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' non-extensible codelist
CT2002	Variable should be populated with terms from its CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.CodeList.Name%' extensible codelist
CT2003	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT
CT2004	Variable must be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms cannot be added into non-extensible codelists.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' non-extensible codelist when %Variable.Config.@Clause.Expression%
CT2005	Variable should be populated with terms from its CDISC controlled terminology codelist when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.	Match	%Variable% value not found in '%Variable.Config.@Clause.CodeList.Name%' extensible codelist when %Variable.Config.@Clause.Expression%
CT2006	Paired variables such as TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value within the same value level condition.	Match	%Variable% and %Variable.DecodedVariable% values do not have the same Code in CDISC CT when %Variable.Config.@Clause.Expression%
SD0001	Domain table should have at least one record.	Property	No records in data source
SD0002	Required variables (where Core attribute is 'Req') cannot be NULL for any records.	Required	NULL value in %Variable% variable marked as Required
SD0037	Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml.	Match	Value for %Variable% not found in (%Variable.CodeList.Name%) user-defined codelist
SD0046	All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM).	Unique	Inconsistent value for QLABEL within QNAM
SD0054	Variables listed in the data definition document (define.xml) should be included in the dataset.	Find	Variable in define.xml is not present in the dataset
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
SD0086	All SUPPQUAL Domains records are associated with a single parent record and must have a unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variable value. For all SUPPQUAL domain record all The QNAM variable should be unique for each parent record.	Unique	SUPPQUAL duplicate records
SD0095	Supplemental Qualifiers special purpose dataset (SUPP--) can only be used to capture non-standard variables and their association to parent records in general-observation-class datasets (Events, Findings, Interventions) and Demographics. Another exception is Subject Visits domain in SDTM-IG prior v3.4.	Condition	Invalid usage of SUPPQUAL for non-general-observation-class Domain
SD1005	Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain.	Lookup	Invalid STUDYID
SD1021	Character values should not have leading space ' ' characters, carriage returns, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables.	Regex	Unexpected character value in %Variable% variable
SD1022	The value of Qualifier Variable Name (QNAM) should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores.	Regex	Invalid value for QNAM variable
SD1029	Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM).	Regex	Non-ASCII or non-printable characters in %Variable% variable
SD1049	Qualifier Variable Label (QLABEL) value may have up to 40 characters.	Regex	Invalid value for QLABEL
SD1051	Both Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) should not be populated when relating information to the Demographics (DM) domain.	Condition	Unexpected value for IDVAR/IDVARVAL
SD1063	Datasets included in study data must be described in the data definition document (define.xml).	Match	Dataset is not present in define.xml
SD1071	Datasets greater than 5 gigabytes (GB) in size should be split into smaller datasets no larger than 5 GB.	Property	Dataset is greater than 5 GB in size
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
SD1120	Comments should be stored in Comments (CO) domain, rather than be put into Supplemental Qualifier (SUPP--) domains.	Condition	Comments in %Domain% domain
SD1130	All values of Qualifier Variable Name (QNAM) should be the same for a given value of Qualifier Variable Label (QLABEL).	Unique	Inconsistent value for QNAM within QLABEL
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
SE0038	Study Day variables (*DY) value should not equal 0.	Condition	Value of %Variable% Study Day variable equals 0
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
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