CDISC SEND 3.0 Validation Rules

The following is a listing of CDISC SEND version 3.0 validation rules implemented in OpenCDISC Validator. The rules are the result of work performed by 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
CT0005	Value for TSVAL not found in (AGEU) CT codelist	TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'AGEU'	TS, POOLDEF	Terminology	Warning
CT0009	Value for DOMAIN not found in (DOMAIN) CT codelist	Domain Abbreviation (DOMAIN) variable values should be populated with terms found in 'Domain Abbreviation' (C66734) CDISC controlled terminology codelist	All	Terminology	Warning
CT0011	Value for EGMETHOD not found in (EGMETHOD) CT codelist	Method of ECG Test (EGMETHOD) variable values should be populated with terms found in 'ECG Test Method' (C71151) CDISC controlled terminology codelist	EG	Terminology	Warning
CT0012	Value for EGSTRESC not found in (EGSTRESC) CT codelist	EG dataset Character Result/Finding in Std Format (EGSTRESC) variable values should be populated with terms found in 'ECG Result' (C71150) CDISC controlled terminology codelist, when EGSTRESC is not numerical value	EG	Terminology	Warning
CT0013	Value for EGTEST not found in (EGTEST) CT codelist	ECG Test or Examination Name (EGTEST) variable values should be populated with terms found in 'ECG Test Name' (C71152) CDISC controlled terminology codelist	EG	Terminology	Warning
CT0014	Value for EGTESTCD not found in (EGTESTCD) CT codelist	ECG Test or Examination Short Name (EGTESTCD) variable values should be populated with terms found in 'ECG Test Code' (C71153) CDISC controlled terminology codelist	EG	Terminology	Warning
CT0018	Value for --DOSFRQ not found in (FREQ) CT codelist	Dosing Frequency per Interval (--DOSFRQ) variables values should be populated with terms found in 'Frequency' (C71113) CDISC controlled terminology codelist	Interventions	Terminology	Warning
CT0019	Value for --DOSFRM not found in (FRM) CT codelist	Dose Form (--DOSFRM) variables values should be populated with terms found in 'Pharmaceutical Dosage Form' (C66726) CDISC controlled terminology codelist	Interventions	Terminology	Warning
CT0021	Value for LBTEST not found in (LBTEST) CT codelist	Lab Test or Examination Name (LBTEST) variable values should be populated with terms found in 'Laboratory Test Name' (C67154) CDISC controlled terminology codelist	LB	Terminology	Warning
CT0022	Value for LBTESTCD not found in (LBTESTCD) CT codelist	Lab Test or Examination Short Name (LBTESTCD) variable values should be populated with terms found in 'Laboratory Test Code' (C65047) CDISC controlled terminology codelist	LB	Terminology	Warning
CT0028	Value for --POS not found in (POSITION) CT codelist	Position of Subject (--POS) variables values should be populated with terms found in 'Position' (C71148) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT0031	Value for --ROUTE not found in (ROUTE) CT codelist	Route of Administration (--ROUTE) variables values should be populated with terms found in 'Route of Administration' (C66729) CDISC controlled terminology codelist	Interventions	Terminology	Warning
CT0032	Value for TSVAL not found in (ROUTE) CT codelist	'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Route of Administration' (C66729) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'ROUTE'	TS, POOLDEF	Terminology	Warning
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
CT0035	Value for TSVAL not found in (SEXPOP) CT codelist	'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Sex of Participants' (C66732) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'SEXPOP'	TS, POOLDEF	Terminology	Warning
CT0049	Value for --DOSU not found in (UNIT) CT codelist	Dose Units (--DOSU) variables values should be populated with terms found in 'Unit' (C71620) CDISC controlled terminology codelist	Interventions, EX	Terminology	Warning
CT0050	Value for --ORRESU not found in (UNIT) CT codelist	Original Units (--ORRESU) variables values should be populated with terms found in 'Unit' (C71620) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT0051	Value for --STRESU not found in (UNIT) CT codelist	Standard Units (--STRESU) variables values should be populated with terms found in 'Unit' (C71620) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT0052	Value for VSORRESU not found in (VSRESU) CT codelist	VS dataset Original Units (VSORRESU) variable values should be populated with terms found in 'Units for Vital Signs Results' (C66770) CDISC controlled terminology codelist	VS	Terminology	Warning
CT0053	Value for VSSTRESU not found in (VSRESU) CT codelist	VS dataset Standard Units (VSSTRESU) variable values should be populated with terms found in 'Units for Vital Signs Results' (C66770) CDISC controlled terminology codelist	VS	Terminology	Warning
CT0054	Value for VSTEST not found in (VSTEST) CT codelist	Vital Signs Test Name (VSTEST) variable values should be populated with terms found in 'Vital Signs Test Name' (C67153) CDISC controlled terminology codelist	VS	Terminology	Warning
CT0055	Value for VSTESTCD not found in (VSTESTCD) CT codelist	Vital Signs Test Short Name (VSTESTCD) variable values should be populated with terms found in 'Vital Signs Test Code' (C66741) CDISC controlled terminology codelist	VS	Terminology	Warning
CT0056	Invalid --STRTPT value	Start Relative to Reference Time Point (--STRTPT) variables values should be populated with 'BEFORE', 'COINCIDENT', 'AFTER', or 'U'	Interventions, Events, Findings, SE	Terminology	Warning
CT0057	Invalid --ENRTPT value	End Relative to Reference Time Point (--ENRTPT) variables values should be populated with 'BEFORE', 'COINCIDENT', 'AFTER', 'ONGOING', or 'U'	Interventions, Events, Findings, SE	Terminology	Warning
CT0058	Value for EXVAMTU not found in (UNIT) CT codelist	Treatment Vehicle Amount Units (EXVAMTU) variable values should be populated with terms found in 'Unit' (C71620) CDISC controlled terminology codelist	EX	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
CT0063	Value for --PRESP not found in (NY) CT codelist	Pre-Specified (--PRESP) variables values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Interventions, Events	Terminology	Warning
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
CT1001	Value for SCTESTCD not found in (SBCCDSND) CT codelist	Subject Characteristic Short Name (SCTESTCD) variable values should be populated with terms found in 'SEND Subject Characteristic Test Code' (C89981) CDISC controlled terminology codelist	SC	Terminology	Warning
CT1002	Value for SCTEST not found in (SBCSND) CT codelist	Subject Characteristic (SCTEST) variable values should be populated with terms found in 'SEND Subject Characteristic Test Name' (C89980) CDISC controlled terminology codelist	SC	Terminology	Warning
CT1003	Value for PPTEST not found in (PKPARM) CT codelist	PP dataset Parameter Name (PPTEST) variable values should be populated with terms found in 'PK Parameters' (C85493) CDISC controlled terminology codelist	PP	Terminology	Warning
CT1004	Value for PPTESTCD not found in (PKPARMCD) CT codelist	PP dataset Parameter Short Name (PPTESTCD) variable values should be populated with terms found in 'PK Parameters Code' (C85839) CDISC controlled terminology codelist	PP	Terminology	Warning
CT1005	Value for --ORRESU not found in (PKUNIT) CT codelist	Original Units (--ORRESU) variables values should be populated with terms found in 'PK Parameter Units of Measure' (C85494) CDISC controlled terminology codelist	PC, PP	Terminology	Warning
CT1006	Value for --STRESU not found in (PKUNIT) CT codelist	Standard Units (--STRESU) variables values should be populated with terms found in 'PK Parameter Units of Measure' (C85494) CDISC controlled terminology codelist	PC, PP	Terminology	Warning
CT1007	Value for SPECIES not found in (SPECIES) CT codelist	Species (SPECIES) variable values should be populated with terms found in 'Species' (C77808) CDISC controlled terminology codelist	DM	Terminology	Warning
CT1008	Value for STRAIN not found in (STRAIN) CT codelist	Strain/Substrain (STRAIN) variable values should be populated with terms found in 'Strain/Substrain' (C77530) CDISC controlled terminology codelist	DM	Terminology	Warning
CT1009	Value for BWTEST not found in (BWTEST) CT codelist	BW dataset Test Name (BWTEST) variable values should be populated with terms found in 'Body Weight Test Name' (C89961) CDISC controlled terminology codelist	BW	Terminology	Warning
CT1010	Value for BWTESTCD not found in (BWTESTCD) CT codelist	BW dataset Test Short Name (BWTESTCD) variable values should be populated with terms found in 'Body Weight Test Code' (C89962) CDISC controlled terminology codelist	BW	Terminology	Warning
CT1011	Value for BGTEST not found in (BGTEST) CT codelist	BG dataset Test Name (BGTEST) variable values should be populated with terms found in 'Body Weight Gain Test Name' (C89959) CDISC controlled terminology codelist	BG	Terminology	Warning
CT1012	Value for BGTESTCD not found in (BGTESTCD) CT codelist	BG dataset Test Short Name (BGTESTCD) variable values should be populated with terms found in 'Body Weight Gain Test Code' (C89959) CDISC controlled terminology codelist	BG	Terminology	Warning
CT1013	Value for CLCAT not found in (CLCAT) CT codelist	Category for Clinical Observations (CLCAT) variable values should be populated with terms found in 'Category for Clinical Observation' (C89963) CDISC controlled terminology codelist	CL	Terminology	Warning
CT1014	Value for --BODSYS not found in (BODSYS) CT codelist	Body System or Organ Class (--BODSYS) variable values should be populated with terms found in 'Body System' (C88026) CDISC controlled terminology codelist	CL, MA, MI	Terminology	Warning
CT1015	Value for --EXCLFL not found in (NY) CT codelist	Exclusion Flag (--EXCLFL) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT1016	Value for DDTEST not found in (DDTEST) CT codelist	Death Diagnosis Name (DDTEST) variable values should be populated with terms found in 'Death Diagnosis Test Name' (C89965) CDISC controlled terminology codelist	DD	Terminology	Warning
CT1017	Value for DDTESTCD not found in (DDTESTCD) CT codelist	Death Diagnosis Short Name (DDTESTCD) variable values should be populated with terms found in 'Death Diagnosis Test Code' (C89966) CDISC controlled terminology codelist	DD	Terminology	Warning
CT1018	Value for FWTEST not found in (FWTEST) CT codelist	Food/Water Consumption Name (FWTEST) variable values should be populated with terms found in 'Food and Water Consumption Test Name' (C89969) CDISC controlled terminology codelist	FW	Terminology	Warning
CT1019	Value for FWTESTCD not found in (FWTESTCD) CT codelist	Food/Water Consumption Short Name (FWTESTCD) variable values should be populated with terms found in 'Food and Water Consumption Test Code' (C89970) CDISC controlled terminology codelist	FW	Terminology	Warning
CT1020	Value for --SPEC not found in (SPEC) CT codelist	Specimen Type (--SPEC) variable values should be populated with terms found in 'Specimen' (C77529) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT1021	Value for MATEST not found in (MATEST) CT codelist	Macroscopic Examination Name (MATEST) variable values should be populated with terms found in 'Macroscopic Findings Test Name' (C89971) CDISC controlled terminology codelist	MA	Terminology	Warning
CT1022	Value for MATESTCD not found in (MATESTCD) CT codelist	Macroscopic Examination Short Name (MATESTCD) variable values should be populated with terms found in 'Macroscopic Findings Test Code' (C89972) CDISC controlled terminology codelist	MA	Terminology	Warning
CT1023	Value for --SEV not found in (SEV) CT codelist	Severity (--SEV) variable values should be populated with terms found in 'Severity' (C90000) CDISC controlled terminology codelist	Events, Findings	Terminology	Warning
CT1024	Value for --DTHREL not found in (NY) CT codelist	Relationship to Death (--DTHREL) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT1025	Value for MITEST not found in (MITEST) CT codelist	Microscopic Examination Name (MITEST) variable values should be populated with terms found in 'Microscopic Findings Test Name' (C89973) CDISC controlled terminology codelist	MI	Terminology	Warning
CT1026	Value for MITESTCD not found in (MITESTCD) CT codelist	Microscopic Examination Short Name (MITESTCD) variable values should be populated with terms found in 'Microscopic Findings Test Code' (C89974) CDISC controlled terminology codelist	MI	Terminology	Warning
CT1027	Value for MIRESCAT not found in (MIRESCAT) CT codelist	MI dataset Result Category (MIRESCAT) variable values should be populated with terms found in 'Microscopic Histopathology Result Category' (C90017) CDISC controlled terminology codelist	MI	Terminology	Warning
CT1028	Value for --SPCUFL not found in (NY) CT codelist	Specimen Usability for the Test (--SPCUFL) variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT1029	Value for OMTEST not found in (OMTEST) CT codelist	OM dataset Test Name (OMTEST) variable values should be populated with terms found in 'Organ Measurement Test Name' (C89976) CDISC controlled terminology codelist	OM	Terminology	Warning
CT1030	Value for OMTESTCD not found in (OMTESTCD) CT codelist	OM dataset Test Short Name (OMTESTCD) variable values should be populated with terms found in 'Organ Measurement Test Code' (C89977) CDISC controlled terminology codelist	OM	Terminology	Warning
CT1031	Value for PMTEST not found in (PHSPRP) CT codelist	PM dataset Test Name (PMTEST) variable values should be populated with terms found in 'Physical Properties Test Name' (C95120) CDISC controlled terminology codelist	PM	Terminology	Warning
CT1032	Value for PMTESTCD not found in (PHSPRPCD) CT codelist	PM dataset Test Short Name (OMTESTCD) variable values should be populated with terms found in 'Physical Properties Test Code' (C95121) CDISC controlled terminology codelist	PM	Terminology	Warning
CT1033	Value for TFTEST not found in (TFTEST) CT codelist	Tumor Examination (TFTEST) variable values should be populated with terms found in 'Tumor Findings Test Name' (C90005) CDISC controlled terminology codelist	TF	Terminology	Warning
CT1034	Value for TFTESTCD not found in (TFTESTCD) CT codelist	Tumor Examination Short Name (TFTESTCD) variable values should be populated with terms found in 'Tumor Findings Test Code' (C90006) CDISC controlled terminology codelist	TF	Terminology	Warning
CT1035	Value for TFRESCAT not found in (NEOSTAT) CT codelist	Tumor Malignancy Status (TFRESCAT) variable values should be populated with terms found in 'Neoplastic Status' (C90004) CDISC controlled terminology codelist	TF	Terminology	Warning
CT1036	Value for --CSTATE not found in (CSTATE) CT codelist	Consciousness State (--CSTATE) variables values should be populated with terms found in 'Consciousness State' (C90018) CDISC controlled terminology codelist	Findings	Terminology	Warning
CT1037	Value for EGCAT not found in (EGCATSND) CT codelist	Category for ECG (EGCAT) variable values should be populated with terms found in 'SEND ECG Category' (C90012) CDISC controlled terminology codelist	EG	Terminology	Warning
CT1038	Value for EGLEAD not found in (EGLEAD) CT codelist	EG dataset Location Used for Measurement (EGLEAD) variable values should be populated with terms found in 'ECG Lead' (C90013) CDISC controlled terminology codelist	EG	Terminology	Warning
CT1039	Value for DSDECOD not found in (DSDECOD) CT codelist	Standardized Disposition Term (DSDECOD) variable values should be populated with terms found in 'Standardized Disposition Term' (C89968) CDISC controlled terminology codelist	DS	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
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, VS	Presence	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	All	Format	Warning
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, SE	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	Limit	Error
SD0014	Negative value for --DOSE	Non-missing Dose (--DOSE) value must be greater than or equal to 0	Interventions, EX	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, SE	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, POOLDEF	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, POOLDEF	Format	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
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, CO	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, CO	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, CO	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, EX	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	All	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
SD0043	Missing value for --TRTV, when --VAMT is not NULL	Treatment Vehicle (--TRTV) should be provided, when Treatment Vehicle Amount (--VAMT) is specified	Interventions, EX	Consistency	Warning
SD0044	Missing value for --VAMTU, when --VAMT is populated	Treatment Vehicle Amount Units (--VAMTU) should not be NULL, when Treatment Vehicle Amount (--VAMT) is populated	Interventions, EX	Consistency	Warning
SD0045	Missing value for --STRESC, when --RESCAT is populated	Character Result/Finding in Std Units (--STRESC) should be provided, when Result Category (--RESCAT) is specified	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
SD0049	Missing value for --STTPT, when --STRTPT is populated	Start Reference Time Point (--STTPT) must not be NULL, when Start Relative to Reference Time Point (--STRTPT) is provided	Interventions, Events, Findings, SE	Consistency	Error
SD0050	Missing value for --ENTPT, when --ENRTPT is populated	End Reference Time Point (--ENTPT) must not be NULL, when End Relative to Reference Time Point (--ENRTPT) is provided	Interventions, Events, Findings, SE	Consistency	Error
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)	TX	Consistency	Warning
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
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
SD0064	Invalid subject	All Subjects (USUBJID) must be present in Demograpics (DM) domain	Interventions, Events, Findings, CO, SE	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	All	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
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
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
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
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
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
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
SD1004	Invalid value for ARMCD	The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length	DM, TA, TX	Format	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, CO, SE, 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, CO, SE	Cross-reference	Warning
SD1015	Invalid EPOCH	Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset	Interventions, Events, Findings, SE	Cross-reference	Warning
SD1020	Missing DM dataset	Demographics (DM) dataset must be included in every submission	DM	Presence	Error
SD1021	Unexpected character value	Character values should not have leading space ' ' characters, or '.' as an entire value	All	Format	Warning
SD1022	Invalid value for QNAM variable	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	SUPPQUAL	Format	Warning
SD1026	Invalid value for IDVAR variable	Relationship Type (RELTYPE) must be NULL, when Identifying Variable (IDVAR) is populated with a --SEQ value	RELREC	Consistency	Error
SD1027	Non-unique value for ELEMENT within ETCD	Description of Element (ELEMENT) must have a unique value for a given value of Element Code (ETCD) within the domain	TE	Consistency	Error
SD1028	Non-unique value for ELEMENT within TESTRL, TEENRL and TEDUR	Description of Element (ELEMENT) must have a unique value for a given combination of Rule for Start of Element (TESTRL), Rule for End of Element (TEENRL), and Planned Duration of Element (TEDUR) within the domain	TE	Consistency	Error
SD1029	Non-ASCII or non-printable characters in variable	Variables value must not include non-ASCII or non-printable characters (outside of 32-127 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM)	All	Format	Warning
SD1033	Inconsistent value for ARM	A value for Description of Planned Arm (ARM) must have a unique value for Planned Arm Code (ARMCD) with the domain	DM, TA	Consistency	Error
SD1034	Inconsistent value for ARMCD	A value for Planned Arm Code (ARMCD) must have a unique value for Description of Planned Arm (ARM) with the domain	DM, TA	Consistency	Error
SD1038	Non-unique value for TSSEQ variable within TSPARMCD	Sequence Number (TSSEQ) must have a unique value for a given value of Trial Summary Parameter Short Name (TSPARMCD) within the domain	TS	Consistency	Error
SD1039	Redundancy in pared variables values	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)	Interventions, Events, Findings	Consistency	Warning
SD1040	Redundancy in pared variables values	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)	Interventions, Events, Findings	Consistency	Warning
SD1041	Values for --CAT and --SCAT are identical	Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical	Interventions, Events, Findings	Consistency	Warning
SD1043	Inconsistent value for --TESTCD within --TEST	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)	Findings	Consistency	Warning
SD1044	No --BLFL variable in custom Findings domain	Baseline Flag (--BLFL) should be present in all custom Findings domains	Findings	Presence	Warning
SD1047	Both --DOSE and --DOSTXT values are populated	Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record	Interventions, EX	Consistency	Error
SD1049	Invalid value for QLABEL	Qualifier Variable Label (QLABEL) value may have up to 40 characters	SUPPQUAL	Format	Error
SD1051	Unexpected value for IDVAR/IDVARVAL	Both Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) should not be populated, when relating information to the Demographics (DM) domain	SUPPQUAL	Consistency	Warning
SD1052	Non-unique value for TAETORD within ARMCD	Order of Element within Arm (TAETORD) must have a unique value for a given value of Planned Arm Code (ARMCD) within the domain	TA	Consistency	Error
SD1054	Non-recommended variable length	The length of flags variables (----FL, --FAST, --OCCUR, --PRESP) is expected to be 1	Interventions, Events, Findings, TA	Metadata	Warning
SD1057	Non-recommended variable length	The length of Test Code (--TESTCD), Element Code (ETCD), a Parameter Short Name (--PARMCD), Qualifier Variable Name (QNAM), Identifying Variable (IDVAR) variables is expected to be 8	Findings, CO, SE, TE, TA, TX, TS, RELREC, SUPPQUAL	Metadata	Warning
SD1058	Non-recommended variable length	The length of Planned Arm Code variable (ARMCD) is expected to be 20	DM, TA	Metadata	Warning
SD1059	Non-recommended variable length	The length of Test Name (--TEST), Parameter (--PARM), Qualifier Variable Name (QLABEL) variables is expected to be 40	Findings,TX, TS, SUPPQUAL	Metadata	Warning
SD1061	Missing MB dataset, when MS dataset is present	Microbiology Specimen (MB) dataset should be included, when a Microbiology Susceptibility Test (MS) dataset is present	MB	Presence	Warning
SE0001	Inconsistent value for Standard Units	Standard Units (--STRESU) variable values must be consistent for all records with same Short Name of Measurement, Test or Examination (--TESTCD) and Specimen Type (--SPEC) variables values	LB, OM, PC	Consistency	Error
SE0002	Invalid value for AGETXT	Age Range (AGETXT) variable values should be populated with 'number-number' format	DM	Format	Warning
SE0005	Duplicate value for --SEQ	The value of Sequence Number (--SEQ) variable must be unique for each record within a Subject (USUBJID) or a Pool (POOLID)	Interventions, Events, Findings, CO, SE, TS, POOLDEF	Consistency	Error
SE0006	Missing TS dataset	Trial Summary (TS) dataset should be included in every submission	TS	Presence	Warning
SE0007	Missing TX dataset	Trial Sets (TX) dataset should be included in every submission	TX	Presence	Warning
SE0008	Missing or redundant values for USUBJID and POOLID	Either Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables values and only one must be populated	Interventions, Events, Findings, CO, SUPPQUAL	Presence	Error
SE0009	Missing values for both --DTC and --DY variables	Start 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	Findings	Presence	Warning
SE0011	Missing value for --TPTREF	Time Point Reference (--TPTREF) variable values should be provided, when Date/Time of Reference Time Point (--RFTDTC) variable values are populated	Interventions, Events, Findings	Consistency	Warning
SE0012	Inconsistent value for --TPT	All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable	Interventions, Events, Findings, CO	Consistency	Warning
SE0013	Inconsistent value for --TPTNUM	All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable	Interventions, Events, Findings, CO	Consistency	Warning
SE0014	Inconsistent value for --TPT	All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable	Interventions, Events, Findings, CO	Consistency	Warning
SE0015	Missing value for --STRESN	Standardized Result in Numeric Format (--STRESN) variable value should be populated when Standardized Result in Character Format (--STRESC) variable value represents a numeric value	Findings	Consistency	Warning
SE0016	Both AGE and AGETXT are populated	Age (AGE) and Age Range (AGETXT) variables should never both be populated for the same subject	DM	Consistency	Warning
SE0017	Missing values for both AGE and AGETXT, when AGEU is provided	Either of Age (AGE) or Age Range (AGETXT) variable values should be provided, when Age Units (AGEU) are populated	DM	Consistency	Warning
SE0018	Missing value for AGEU, when AGE or AGETXT is populated	Age Units (AGEU) variable values should be provided, when Age (AGE) or Age Range (AGETXT) variables values are populated	DM	Consistency	Warning
SE0019	AGE is not provided	Age (AGE) variable values should be provided, when Date/Time of Birth (BRTHDTC) variablw values are no populated	DM	Consistency	Warning
SE0055	SEND/dataset variable type mismatch	Variable Data Types in the dataset should match the variable data types described in SEND	All	Metadata	Warning
SE0056	SEND Required variable not found	Variables described in SEND as Required must be included in the dataset	All	Metadata	Error
SE0057	SEND Expected variable not found	Variables described in SEND as Expected should be included in the dataset	All	Metadata	Warning
SE0058	Variable appears in dataset but is not in SEND standard	Only variables listed in SEND 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
SE0063	SEND/dataset variable label mismatch	Variable Label in the dataset should match the variable label described in SEND. 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
SE1001	Invalid value for RELTYPE	Relationship Type (RELTYPE) variable values should be populated with terms 'ONE', 'MANY'	RELREC	Consistency	Warning
SE1002	Inconsistent value for --PARM within --PARMCD	All values of a Parameter (--PARM) variables should be the same for a given value of a Parameter Short Name (--PARMCD) variables	TX	Consistency	Warning
SE1003	Inconsistent value for --PARMCD within --PARM	All values of a Parameter Short Name (--PARMCD) variables should be the same for a given value of a Parameter (--PARM) variables	TX	Consistency	Warning