CDISC SDTM 3.1.1 Validation Rules

The following is a listing of CDISC SDTM version 3.1.1 validation rules implemented in OpenCDISC Validator. The list includes all Janus validation rules as defined in the Janus SDTM Validation Specification v.1 and additional rules defined by the OpenCDISC team and community.

Rule ID	Message	Description	Domain	Category	Severity
CT0004	Value for AGEU not found in (AGEU) CT codelist	Age Units (AGEU) variable values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist	DM	Terminology	Error
CT0006	Value for COUNTRY not found in (COUNTRY) CT codelist	Country (COUNTRY) variable values should be populated with terms found in 'Country' (C66786) CDISC controlled terminology codelist	DM	Terminology	Warning
CT0020	Value for IECAT not found in (IECAT) CT codelist	Inclusion/Exclusion Category (IECAT) variable values should be populated with terms found in 'Category for Inclusion/Exclusion' (C66797) CDISC controlled terminology codelist	IE	Terminology	Error
CT0034	Value for SEX not found in (SEX) CT codelist	Sex (SEX) variable values should be populated with terms found in 'Sex' (C66731) CDISC controlled terminology codelist	DM	Terminology	Error
CT0038	Value for --STRF not found in (STENRF) CT codelist	End Relative to Reference Period (--STRF) variables values should be populated with terms found in 'Relation to Reference Period' (C66728) CDISC controlled terminology codelist	Interventions, Events	Terminology	Error
CT0039	Value for --ENRF not found in (STENRF) CT codelist	End Relative to Reference Period (--ENRF) variables values should be populated with terms found in 'Relation to Reference Period' (C66728) CDISC controlled terminology codelist	Interventions, Events	Terminology	Error
CT0044	Value for AETOXGR not found in (TOXGR) CT codelist	Standard Toxicity Grade (AETOXGR) variable values should be populated with terms found in 'Common Terminology Criteria for Adverse Events V4.0' (C87162) CDISC controlled terminology codelist	AE	Terminology	Warning
CT0059	Value for --BLFL not found in (NY) CT codelist	Baseline Flag (--BLFL) variables values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT0060	Value for --DRVFL not found in (NY) CT codelist	Derived Flag (--DRVFL) variables values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Error
CT0061	Value for --FAST not found in (NY) CT codelist	Fasting Status (--FAST) variables values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Error
CT0062	Value for --OCCUR not found in (NY) CT codelist	Occurrence (--OCCUR) variables values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Interventions, Events	Terminology	Error
CT0064	Value for AESER not found in (NY) CT codelist	Serious Event (AESER) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0065	Value for AESCONG not found in (NY) CT codelist	Congenital Anomaly or Birth Defect (AESCONG) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0066	Value for AESDISAB not found in (NY) CT codelist	Persist or Signif Disability/Incapacity (AESDISAB) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0067	Value for AESDTH not found in (NY) CT codelist	Results in Death (AESDTH) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0068	Value for AESHOSP not found in (NY) CT codelist	Requires or Prolongs Hospitalization (AEHOSP) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0069	Value for AESLIFE not found in (NY) CT codelist	Is Life Threatening (AESLIFE) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0070	Value for AECONTRT not found in (NY) CT codelist	Concomitant or Additional Trtmnt Given (AECONTRT) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0071	Value for AESCAN not found in (NY) CT codelist	Involves Cancer (AESCAN) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0072	Value for AESMIE not found in (NY) CT codelist	Other Medically Important Serious Event (AESMIE) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0073	Value for AESOD not found in (NY) CT codelist	Occurred with Overdose (AESOD) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error
CT0074	Value for IEORRES not found in (NY) CT codelist	I/E Criterion Original Result (IEORRES) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	IE	Terminology	Error
CT0075	Value for IESTRESC not found in (NY) CT codelist	I/E Criterion Result in Std Format (IESTRESC) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	IE	Terminology	Error
CT0076	Value for --STAT not found in (ND) CT codelist	Completion Status (--STAT) variables values should be populated with terms found in 'Not Done' (C66789) CDISC controlled terminology codelist	Interventions, Events, Findings	Terminology	Warning
SD0001	No records in data source	'Domain table should have at least one record	All	Presence	Warning
SD0002	Null value in variable marked as Required	Required variables (where Core attribute is 'Req') cannot be NULL for any records	All	Presence	Error
SD0003	Invalid ISO 8601 value	Dates and times of day must conform to the ISO 8601 international standard	All	Format	Error
SD0004	Inconsistent value for DOMAIN	Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset	All	Consistency	Warning
SD0005	Duplicate --SEQ	The value of Sequence Number (--SEQ) variable must be unique for each record within a subject	Interventions, Events, Findings, CO, SE, TS	Consistency	Error
SD0006	No baseline result in [Domain] for subject	All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, QS, and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN')	EG, LB, QS, VS	Presence	Warning
SD0007	Inconsistent value for Standard Units	Standard Units (--STRESU) must be consistent for all records with same Short Name of Measurement, Test or Examination (--TESTCD) and Category (--CAT)	EG, LB, QS, VS	Consistency	Error
SD0008	Value for --DECOD not found in MedDRA dictionary	Value for the Dictionary-Derived Term (--DECOD) variable must be populated using a Prefered Term of the MedDRA dictionary of a version specified in the define.xml	AE	Terminology	Error
SD0009	No qualifiers set to 'Y', when AE is Serious	When Serious Event (AESER) variable value is 'Y', then at least one of seriousness criteria variables is expected to have value 'Y' (Involves Cancer (AESCAN), Congenital Anomaly or Birth Defect (AESCONG), Persist or Signif Disability/Incapacity (AESDISAB)	AE	Consistency	Warning
SD0010	VISITNUM is formatted with more than 3 decimal places	Visit Number (VISITNUM) variable value is expected to be formatted up to three decimal places	Interventions, Events, Findings, SV	Format	Warning
SD0011	ARM is not 'Screen Failure', when ARMCD equals 'SCRNFAIL', or vice versa	Description of Arm (ARM) must equal 'Screen Failure', when Arm Code (ARMCD) is 'SCRNFAIL', and vice versa	DM, TA	Consistency	Error
SD0012	--STDY is after --ENDY	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)	Interventions, Events, Findings	Limit	Error
SD0013	--STDTC is after --ENDTC	Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC)	Interventions, Events, Findings, DM, SE, SV	Limit	Error
SD0014	Negative value for --DOSE	Non-missing Dose (--DOSE) value must be greater than or equal to 0	Interventions	Limit	Error
SD0015	Negative value for --DUR	Non-missing Duration of Event, Exposure or Obseravtion (--DUR) value must be greater than or equal to 0	Interventions, Events, Findings	Limit	Error
SD0016	Missing value for --STRESC, when --DRVFL='Y'	Character Result/Finding in Std Format (--STRESC) value should not be NULL, when Derived Flag (--DRVFL) value is 'Y'	Findings	Consistency	Warning
SD0017	Invalid value for --TEST variable	The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length	Findings	Format	Warning
SD0018	Invalid value for --TESTCD variable	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	Findings	Format	Warning
SD0019	Invalid value for TSPARM variable	The value of Trial Summary Parameter (TSPARM) should be no more than 40 characters in length	TS	Format	Warning
SD0020	Invalid value for TSPARMCD variable	The value of Trial Summary Parameter Short Name (TSPARMCD) should be no more than 8 characters in length	TS	Format	Warning
SD0021	Missing value for --ENRF, when --ENDTC is NULL and --OCCUR is not 'N'	End Relative to Reference Period (--ENRF) should not be NULL, when End Date/Time of Event or Exposure (--ENDTC) value is missing and Occurrence (--OCCUR) does not equal 'N'	Interventions, Events, Findings	Consistency	Warning
SD0022	Missing value for --STRF, when --STDTC is NULL and --OCCUR is not 'N'	Start Relative to Reference Period (--STRF) should not be NULL, when Start Date/Time of Event or Exposure (--STDTC) value is missing and Occurrence (--OCCUR) does not equal 'N'	Interventions, Events, Findings	Consistency	Warning
SD0023	Missing value for --STAT, when --REASND is provided	Completion Status (--STAT) should be set to 'NOT DONE', when Reason Not Done (--REASND) is populated	Interventions, Events, Findings	Consistency	Warning
SD0024	Missing value for --DTC, when --ENDTC is provided	Date/Time of Collection (--DTC) should not be NULL, when End Date/Time of Observation (--ENDTC) is not NULL	Findings	Consistency	Warning
SD0025	--DTC is after --ENDTC	Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC)	Findings	Limit	Error
SD0026	Missing value for --ORRESU, when --ORRES is provided	Original Units (--ORRESU) should not be NULL, when Result or Finding in Original Units (--ORRES) is provided	Findings	Consistency	Warning
SD0027	Missing value for --ORRES, when --ORRESU is provided	Result or Finding in Original Units (--ORRES) should not be NULL, when Original Units (--ORRESU) is provided	Findings	Consistency	Warning
SD0028	Value for --STNRHI is less than value for --STNRLO	Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value	Findings	Limit	Error
SD0029	Missing value for --STRESU, when --STRESC is provided	Standard Units (--STRESU) should not be NULL, when Character Result/Finding in Std Units (--STRESC) is provided	Findings	Consistency	Warning
SD0030	Missing value for --STRESC, when --STRESU is provided	Character Result/Finding in Std Units (--STRESC) should not be NULL, when Standard Units (--STRESU) is provided	Findings	Consistency	Warning
SD0031	Missing values for --STDTC and --STRF, when --ENDTC or --ENRF is provided	Start Date/Time of Observation (--STDTC) or Start Relative to Reference Period (--STRF) should not be NULL, when End Date/Time of Observation (--ENDTC) or End Relative to Reference Period (--ENRF) is not NULL	Interventions, Events	Consistency	Warning
SD0032	Missing value for --TPT, when --TPTNUM is provided	Planned Time Point Name (--TPT) should not be NULL, when Planned Time Point Number (--TPTNUM) is populated	Interventions, Events, Findings	Consistency	Warning
SD0033	Missing value for --TPTNUM, when --TPT is provided	Planned Time Point Number (--TPTNUM) should not be NULL, when Planned Time Point Name (--TPT) is populated	Interventions, Events, Findings	Consistency	Warning
SD0034	Missing value for --TPTREF, when --ELTM is provided	Time Point Reference (--TPTREF) should not be NULL, when Planned Elapsed Time from Time Point Ref (--ELTM) is populated	Interventions, Events, Findings	Consistency	Warning
SD0035	Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided	Dose Units (--DOSU) must be populated, when Dose per Administration (--DOSE) or Dose Description (--DOSTXT) is provided	Interventions	Consistency	Error
SD0036	Missing value for --STRESC, when --ORRES is provided	Character Result/Finding in Std Units (--STRESC) must be populated, when Result or Finding in Original Units (--ORRES) is provided	Findings	Consistency	Error
SD0037	Value for [Variable] not found in [CodeList] user-defined codelist	Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml	All	Terminology	Warning
SD0038	Value of Study Day variable equals 0	Study Day variables (*DY) value should not equal 0	Interventions, Events, Findings, DM, SV	Limit	Warning
SD0040	Inconsistent value for --TEST within --TESTCD	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)	Findings	Consistency	Warning
SD0046	Inconsistent value for QLABEL within QNAM	All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM)	SUPPQUAL	Consistency	Warning
SD0047	Missing value for --ORRES, when --STAT or --DRVFL is not populated	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	Findings	Consistency	Warning
SD0048	Value for --ORRES is populated, when --STAT is 'NOT DONE'	Status (--STAT) should be NULL, when Result or Finding in Original Units (--ORRES) is provided	Findings	Consistency	Warning
SD0051	Inconsistent value for VISIT within VISITNUM	All values of Visit Name (VISIT) should be the same for a given value of Visit Number (VISITNUM)	SV, TV	Consistency	Warning
SD0052	Inconsistent value for VISITNUM within VISIT	All values of Visit Number (VISITNUM) should be the same for a given value of Visit Name (VISIT)	SV, TV	Consistency	Warning
SD0053	ARM is not 'Not Assigned', when ARMCD equals 'NOTASSGN', or vice versa	Description of Arm (ARM) must equal 'Not Assigned', when Arm Code (ARMCD) is 'NOTASSGN', and vice versa	DM, TA	Consistency	Error
SD0054	Variable in define.xml is not present in the dataset	Variables listed in the data definition document (define.xml) should be included in the dataset	All	Metadata	Warning
SD0055	SDTM/dataset variable type mismatch	Variable Data Types in the dataset should match the variable data types described in SDTM	All	Metadata	Warning
SD0056	SDTM Required variable not found	Variables described in SDTM as Required must be included in the dataset	All	Metadata	Error
SD0057	SDTM Expected variable not found	Variables described in SDTM as Expected should be included in the dataset	All	Metadata	Warning
SD0058	Variable appears in dataset, but is not in SDTM standard	Only variables listed in SDTM should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified	All	Metadata	Warning
SD0059	Define.xml/dataset variable type mismatch	Variable Data Types in the dataset must match the variable data types described in the data definition document (define.xml)	All	Metadata	Error
SD0060	Variable in dataset is not present in define.xml	Variables included in the dataset must be described in the data definition document (define.xml)	All	Metadata	Error
SD0061	Domain referenced in define.xml but dataset is missing	Domains referenced in data definition document (define.xml) should be included in the submission	All	Metadata	Warning
SD0062	Incompatible data source	Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited)	All	Format	Error
SD0063	SDTM/dataset variable label mismatch	Variable Label in the dataset should match the variable label described in SDTM. 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	All	Metadata	Warning
SD0064	Invalid subject	All Subjects (USUBJID) must be present in Demograpics (DM) domain	Interventions, Events, Findings, CO, SE, SV	Cross-reference	Error
SD0065	Invalid Subject Visit/Visit Number	All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain	Interventions, Events, Findings, SV	Cross-reference	Warning
SD0066	Invalid ARMCD	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')	DM	Cross-reference	Warning
SD0067	Invalid ETCD	Element Code (ETCD) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN')	SE, TA	Cross-reference	Warning
SD0068	Invalid IETESTCD	A value for Inclusion/Exclusion Criterion Short Name (IETESTCD) must be present the Trial Inclusion/Exclusion Criteria (TI) domain	IE	Cross-reference	Error
SD0069	No Disposition record found for subject	All Demographics (DM) subjects (USUBJID) should have at least one record in the Disposition (DS) domain	DM	Presence	Warning
SD0070	No Exposure record found for subject	All Demographics (DM) subjects (USUBJID) participating in a study that includes investigational product should have at least one record in the Exposure (EX) domain, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN')	DM	Presence	Warning
SD0071	Invalid ARM/ARMCD	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 = 'NOTASSG	DM	Cross-reference	Error
SD0072	Invalid RDOMAIN	Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data	CO	Consistency	Error
SD0075	Invalid IDVAR	Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain	RELREC	Consistency	Error
SD0077	Invalid referenced record	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	RELREC	Cross-reference	Error
SD0079	EX record is present, when subject is not assigned to an arm	Subjects that have withdrawn from a trial before assignment to an Arm (ARMCD='NOTASSGN') should not have any Exposure records	EX	Consistency	Warning
SD0080	AE start date is after the latest Disposition date	Start Date/Time of Adverse Event (AESTDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC)	AE	Consistency	Warning
SD0081	Observation date is after the latest Disposition date	Date/Time of Collection (--DTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC)	EG, LB, VS	Consistency	Warning
SD0082	Exposure end date is after the latest Disposition date	End Date/Time of Treatment (EXENDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC)	EX	Consistency	Warning
SD0083	Duplicate USUBJID	The value of Unique Subject Identifier (USUBJID) variable must be unique for each subject across all trials in the submission	DM	Consistency	Error
SD0084	Negative value for AGE	The value of Age (AGE) cannot be less than 0	DM	Limit	Error
SD0085	Mismatch between IEORRES and IESTRESC values	I/E Criterion Original Result (IEORRES) and I/E Criterion Result in Std Format (IESTRESC) should have the same value	IE	Consistency	Warning
SD0086	SUPPQUAL duplicate records	All SUPPQUAL Domains records must have unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variables values	SUPPQUAL	Consistency	Error
SD0087	RFSTDTC is not provided for a randomized subject	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'	DM	Consistency	Warning
SD0088	RFENDTC is not provided for a randomized subject	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'	DM	Consistency	Warning
SD0089	Missing values for TEENRL and TEDUR	At least one of Rule for End of Element (TEENRL) or Planned Duration of Element (TEDUR) should be populated	TE	Consistency	Warning
SD0090	AESDTH is not 'Y', when AEOUT='FATAL'	Results in Death (AEDTH) should equal 'Y', when Outcome of Adverse Event (AEOUT) is 'FATAL'	AE	Consistency	Warning
SD0091	AEOUT is not 'FATAL', when AESDTH='Y'	Outcome of Adverse Event should equal 'FATAL', when Results in Death (AEDTH) is 'Y'	AE	Consistency	Warning
SD0092	Missing value for SEUPDES, when ETCD='UNPLAN'	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'	SE	Consistency	Warning
SD0093	Missing value for AGEU, when AGE is provided	Age Units (AGEU) should be provided, when Age (AGE) is populated	DM	Consistency	Warning
SD0095	SUPPQUAL dataset is used for non-general-observation-class Domain	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	SUPPQUAL	Presence	Error
SD1001	Duplicate SUBJID	The value of Subject Identifier for the Study (SUBJID) variable must be unique for each subject within the study	DM	Consistency	Error
SD1002	RFSTDTC is after RFENDTC	Subject Reference Start Date/Time (RFSTDTC) must be less than or equal to Subject Reference End Date/Time (RFENDTC)	DM	Limit	Error
SD1003	Missing value for AGE, when AGEU is provided	Age (AGE) should be provided, when Age Units (AGEU) are populated	DM	Consistency	Warning
SD1005	Invalid STUDYID	Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain	All	Consistency	Error
SD1008	CODTC is populated, when comment is a child record of another domain	The value of Date/Time of Comment (CODTC) should be NULL, when comments are related to a specific parent record or group of parent records in a domain (RDOMAIN, IDVAR and IDVARVAL are populated)	CO	Consistency	Warning
SD1009	Invalid value for ETCD	The value of Element Code (ETCD) should be no more than 8 characters in length	SE	Format	Warning
SD1010	ELEMENT value is populated, when ETCD= 'UNPLAN'	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'	SE	Consistency	Warning
SD1011	Invalid ISO 8601 value	Duration, Elapsed Time, and Interval values must conform to the ISO 8601 international standard	Interventions, Events, Findings, TE	Format	Error
SD1012	Invalid ETCD/ELEMENT	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')	SE, TA	Cross-reference	Warning
SD1013	TAETORD is populated, ETCD = 'UNPLAN'	Planned Order of Elements within Arm (TAETORD) should be NULL, when subject's experience for a particular period of time is represented as an unplanned Element (ETCD = 'UNPLAN')	SE	Consistency	Warning
SD1014	Invalid TAETORD	Order of Element within Arm (TAETORD) values should match entries in the Trial Arms (TA) dataset	Interventions, Events, Findings	Cross-reference	Warning
SD1015	Invalid EPOCH	Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset	Interventions, Events, Findings	Cross-reference	Warning
SD1016	Invalid IETESTCD/IETEST/IECAT	The combination of Inclusion/Exclusion Criterion Short Name (IETESTCD), Criterion (IETEST), and Category (IECAT) values should match entries in the Trial Inclusion/Exclusion Criteria (TI) dataset	IE	Cross-reference	Warning
SD1017	Invalid VISITNUM	Visit Number (VISITNUM) values should match entries in the Trial Visits (TV) dataset, when they are planned visits (SVUPDES = NULL)	SV	Cross-reference	Warning
SD1018	Invalid VISITNUM/VISIT/VISITDY	The combination of Visit Number (VISITNUM), Visit Name (VISIT), and Planned Study Day of Visit (VISITDY) values should match entries in the Trial Visits (TV) dataset, when they are planned visits (SVUPDES = NULL)	SV	Cross-reference	Warning
SD1019	VISITDY is populated for unplanned visit	Planned Study Day of Visit (VISITDY) should equal NULL for unplanned visits, where Description of Unplanned Visit (SVUPDES) is populated	SV	Consistency	Warning
SD1020	Missing DM dataset	Demographics (DM) dataset must be included in every submission	DM	Presence	Error