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