CDISC SDTM 3.1.2 Amendment 1 Validation Rules

The following is a listing of CDISC SDTM version 3.1.2 Amendment 1 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
CT0001 Value for --ACN not found in (ACN) CT codelist Action Taken with Study Treatment (--ACN) variable values should be populated with terms found in 'Action Taken with Study Treatment' (C66767) CDISC controlled terminology codelist AE Terminology Warning
CT0002 Value for AESEV not found in (AESEV) CT codelist Severity/Intensity (AESEV) variable values should be populated with terms found in 'Severity/Intensity Scale for Adverse Events' (C66769) CDISC controlled terminology codelist AE Terminology Warning
CT0003 Value for TSVAL not found in (AGESPAN) CT codelist TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Age Span' (C66780) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'AGESPAN' TS Terminology Warning
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 Terminology Warning
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
CT0007 Value for DATEST not found in (DATEST) CT codelist Name of Accountability Assessment (DATEST) variable values should be populated with terms found in 'Drug Accountability Test Name' (C78731) CDISC controlled terminology codelist DA Terminology Warning
CT0008 Value for DATESTCD not found in (DATESTCD) CT codelist Short Name of Accountability Assessment (DATESTCD) variable values should be populated with terms found in 'Drug Accountability Test Code' (C78732) CDISC controlled terminology codelist DA 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
CT0010 Value for DSCAT not found in (DSCAT) CT codelist Category for Disposition Event (DSCAT) variable values should be populated with terms found in 'Category for Disposition Event' (C74558) CDISC controlled terminology codelist DS 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
CT0015 Value for ETHNIC not found in (ETHNIC) CT codelist Ethnicity (ETHNIC) variable values should be populated with terms found in 'Ethnic Group' (C66790) CDISC controlled terminology codelist DM Terminology Warning
CT0016 Value for --EVAL not found in (EVAL) CT codelist Evaluator (--EVAL) variables values should be populated with terms found in 'Evaluator' (C78735) CDISC controlled terminology codelist CO, Findings Terminology Warning
CT0017 Value for QEVAL not found in (EVAL) CT codelist Evaluator (QEVAL) variable values should be populated with terms found in 'Evaluator' (C78735) CDISC controlled terminology codelist SUPPQUAL 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
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, TI Terminology Error
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
CT0023 Value for --LOC not found in (LOC) CT codelist Location (--LOC) variables values should be populated with terms found in 'Anatomical Location' (C74456) CDISC controlled terminology codelist Interventions, Events, Findings Terminology Warning
CT0024 Value for SCSTRESC not found in (MARISTAT) CT codelist Character Result/Finding in Std Format (SCSTRESC) variable values should be populated with terms found in 'Marital Status' (C76348) CDISC controlled terminology codelist, when Subject Characteristic Short Name (SCTESTCD) is 'MARISTAT' SC Terminology Warning
CT0025 Value for DSDECOD not found in (NCOMPLT) CT codelist Standardized Disposition Term (DSDECOD) variable values should be populated with terms found in 'Completion/Reason for Non-Completion' (C66727) CDISC controlled terminology codelist, when Category for Disposition Event (DSCAT) value is 'DISPOSITION EVENT DS Terminology Warning
CT0026 Value for --NRIND not found in (NRIND) CT codelist Reference Range Indicator (--NRIND) variables values should be populated with terms found in 'Reference Range Indicator' (C78736) CDISC controlled terminology codelist Findings Terminology Warning
CT0027 Value for --OUT not found in (OUT) CT codelist Outcome (--OUT) variables values should be populated with terms found in 'Outcome of Event' (C66768) CDISC controlled terminology codelist AE 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
CT0029 Value for RACE not found in (RACE) CT codelist Race (RACE) variable values should be populated with terms found in 'Race' (C74457) CDISC controlled terminology codelist DM Terminology Warning
CT0030 Value for RELTYPE not found in (RELTYPE) CT codelist Relationship Type (RELTYPE) variable values should be populated with terms found in 'Relationship Type' (C78737) CDISC controlled terminology codelist RELREC 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 Terminology Warning
CT0033 Value for SCTESTCD not found in (SCCD) CT codelist Subject Characteristic Short Name (SCTESTCD) variable values should be populated with terms found in 'Subject Characteristic Code' (C74559) CDISC controlled terminology codelist SC 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 Terminology Warning
CT0036 Value for VSSTRESC not found in (SIZE) CT codelist Character Result/Finding in Std Format (VSSTRESC) variable values should be populated with terms found in 'Size' (C66733) CDISC controlled terminology codelist, when Vital Signs Test Short Name (VSTESTCD) value is 'FRMSIZE' VS Terminology Warning
CT0037 Value for --BODSYS not found in (SOC) CT codelist Body System or Organ Class (--BODSYS) variable values should be populated with terms found in 'CDISC System Organ Class' (C66783) CDISC controlled terminology codelist Events, PE Terminology Warning
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, Findings, SE, SV 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, Findings, SE, SV Terminology Error
CT0040 Value for TSVAL not found in (TBLIND) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Trial Blinding Schema' (C66735) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TBLIND' TS Terminology Warning
CT0041 Value for TSVAL not found in (TCNTRL) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Control Type' (C66785) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TCNTRL' TS Terminology Warning
CT0042 Value for TSVAL not found in (TDIGRP) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Diagnosis Group' (C66787) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TDIGRP' TS Terminology Warning
CT0043 Value for TSVAL not found in (TINDTP) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Trial Indication Type' (C66736) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TINDTP' TS Terminology Warning
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
CT0045 Value for TSVAL not found in (TPHASE) CT codelist TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Trial Phase' (C66737) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TPHASE' TS Terminology Warning
CT0046 Value for TSPARM not found in (TSPARM) CT codelist Trial Summary Parameter (TSPARM) variable values should be populated with terms found in 'Trial Summary Parameter Test Name' (C67152) CDISC controlled terminology codelist TS Terminology Warning
CT0047 Value for TSPARMCD not found in (TSPARMCD) CT codelist Trial Summary Parameter Short Name (TSPARMCD) variable values should be populated with terms found in 'Trial Summary Parameter Test Code' (C66738) CDISC controlled terminology codelist TS Terminology Warning
CT0048 Value for TSVAL not found in (TTYPE) CT codelist TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Trial Type' (C66739) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'TTYPE' TS 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 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, SV 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, SV 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
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
CT0077 Value for TSVAL not found in (NY) CT codelist TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'ADDON' TS Terminology Warning
CT0078 Value for TSVAL not found in (NY) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'ADDON' TS Terminology Warning
CT0079 Value for TSVAL not found in (FREQ) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Frequency' (C71113) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'DOSFREQ' TS Terminology Warning
CT0080 Value for TSVAL not found in (UNIT) CT codelist 'TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Unit' (C71620) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'DOSU' TS 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, SV, 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 All 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, SE, SV 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, SE, SV 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 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 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, SE, SV 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 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
SD0041 Value for --OCCUR is populated for unsolicited Intervention or Event Occurrence (--OCCUR) may only be populated, when a given Intervention or Event has been pre-specified (--PRESP = 'Y') Interventions, Events Consistency Error
SD0042 --STAT does not equal 'NOT DONE', when --PRESP='Y' and --OCCUR is NULL When no response is provided for Occurrence (--OCCUR) for a pre-specified Intervention or Event (--PRESP = 'Y'), then Status (--STAT) should be set to 'NOT DONE' Interventions, Events 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 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 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, SV 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, SV 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) 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 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
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, RELREC, SUPPQUAL Consistency Error
SD0075 Invalid IDVAR Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain CO, RELREC, SUPPQUAL 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 CO, RELREC, SUPPQUAL 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
SD0094 DSCAT is not 'DISPOSITION EVENT', when EPOCH is provided Category for Disposition Event (DSCAT) should equal 'DISPOSITION EVENT', when Epoch (EPOCH) is provided DS 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
SD1004 Invalid value for ARMCD The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length DM, TA, TV 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, SV Cross-reference Warning
SD1015 Invalid EPOCH Epoch (EPOCH) values should match entries in the Trial Arms (TA) dataset Interventions, Events, Findings, SE, SV 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
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
SD1023 Invalid VISIT/VISITNUM Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain All Cross-reference 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
SD1030 Value for --STRF is populated, when RFSTDTC is NULL Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC) Interventions, Events, Findings, SE, SV Consistency Warning
SD1031 Value for --ENRF is populated, when RFENDTC is NULL End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC) Interventions, Events, Findings, SE, SV Consistency Warning
SD1032 No records for 'SCRFAIL' subject are found in IE domain All subjects with Planned Arm Code (ARMCD) equals 'SCRNFAIL' should have records in the Inclusion/Exclusion Criteria Not Met (IE) domain DM Consistency 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, TV 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, TV Consistency Error
SD1035 Missing value for DSCAT Category for Disposition Event (DSCAT) should be populated DS Presence Warning
SD1036 Missing value for --TOXGR, when --TOX is populated Toxicity Grade (--TOXGR) should be provided, when Toxicity (--TOX) is populated MH, CE, EG, LB, PC, PP Consistency Warning
SD1037 Missing value for --TOX, when --TOXGR is populated Toxicity (--TOX) should be provided, when Toxicity Grade (--TOXGR) is populated MH, CE, EG, LB, PC, PP Consistency Warning
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, TI 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, TI 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, TI Consistency Warning
SD1042 Time point for non-occurred event or intervation is provided Value of Start Relative to Reference Period (--STRF) or End Relative to Reference Period (--ENRF) should not be populated, when an event or intervention is marked as not occurred (--OCCUR='N') Interventions, Events 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
SD1045 Inconsistent values for IEORRES/IECAT I/E Criterion Original Result (IEORRES) must equal 'Y', when Inclusion/Exclusion Category (IECAT) is 'EXCLUSION' IE Consistency Error
SD1046 Inconsistent values for IEORRES/IECAT I/E Criterion Original Result (IEORRES) must equal 'N', when Inclusion/Exclusion Category (IECAT) is 'INCLUSION' IE Consistency Error
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 Consistency Error
SD1049 Invalid value for QLABEL Qualifier Variable Label (QLABEL) value may have up to 40 characters SUPPQUAL Format Error
SD1050 Non-unique value for ETCD within ELEMENT Element Code (ETCD) must have a unique value for a given value of Description of Element (ELEMENT) within the domain TE Consistency 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
SD1053 Unexpected value for ARMCD variable Records for subjects who failed a screening or were not assigned to study treatment (ARMCD is 'SCRNFAIL' or 'NOTASSGN') should not be included in the Trial Arms (TA) or Trial Visits (TV) datasets TA, TV Consistency Warning
SD1054 Non-recommended variable length The length of flags variables (----FL, --FAST, --OCCUR, --PRESP) is expected to be 1 Interventions, Events, Findings, DM Metadata Warning
SD1055 Non-recommended variable length The length of AE flags variables (AESER, AESCAN, AESCONG, AESDISAB, AESDTH, AEHOSP, AESLIFE, AESOD, AESMIE, AECONTRT) is expected to be 1 AE Metadata Warning
SD1056 Non-recommended variable length The length of IE Criterion Result variables (IEORRES, IESTRESC) is expected to be 1 IE 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, TV 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 Metadata Warning
SD1060 Duplicate VISITNUM 'The value of Visit NUmber (VISITNUM) variable should be unique for each record within a subject SV Consistency 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
SD1062 AESER is not 'Y', when AESOD equals 'Y' Serious Event (AESER) variable value is expected to be 'Y', when Occurred with Overdose (AESOD) variable value equals 'Y' AE Consistency Warning
SD2001 Invalid value for ACTARMCD The value of Actual Arm Code (ACTARMCD) should be no more than 20 characters in length DM Format Warning
SD2002 Invalid value for ACTARMCD Actual Arm Code (ACTARMCD) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening ('SCRNFAIL'), or were not fully assigned to an Arm ('NOTASSGN'), or randomized but not treated ('NOTTRT'), or recieved non-pl DM Cross-reference Warning
SD2003 Invalid value for ACTARM Description of Actual Arm (ACTARM) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening ('Screen Failure'), or were not fully assigned to an Arm ('Not Assigned'), or randomized, but not treated ('Not Treated DM Cross-reference Warning
SD2004 Missing value for DTHFL, when DTHDTC is populated Subject Death Flag (DTHFL) value must equal 'Y', when Date/Time of Death (DTHDTC) is provided DM Consistency Warning
SD2005 Missing value for DTHDTC, when DTHFL is populated Date/Time of Death (DTHDTC) should be provided, when subject died (DTHFL=Y) DM Consistency Warning
SD2006 Unexpected MedDRA coding in the SUPPQUAL domain MedDRA coding info should be populated using variables in the Events General Observation Class, but not in SUPPQUAL domains SUPPQUAL Consistency Warning
SD2007 Value for --PTCD not found in MedDRA dictionary Value for Preferred Term Code (--PTCD) variable should be populated using a Prefered Term Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2008 Value for --LLT not found in MedDRA dictionary Value for Lowest Level Term (--LLT) variable should be populated using a Lowest Level Term of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2009 Value for --LLTCD not found in MedDRA dictionary Value for Lowest Level Term Code (--LLTCD) variable should be populated using a Lowest Level Term Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2010 Value for --HLT not found in MedDRA dictionary Value for High Level Term (--HLT) variable should be populated using a High Level Term of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2011 Value for --HLTCD not found in MedDRA dictionary Value for High Level Term Code (--HLTCD) variable should be populated using a High Level Term Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2012 Value for --HLGT not found in MedDRA dictionary Value for High Level Group Term (--HLGT) variable should be populated using a High Level Group Term of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2013 Value for --HLGTCD not found in MedDRA dictionary Value for High Level Group Term Code (--HLGTCD) variable should be populated using a High Level Group Term Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2014 Value for --BDSYCD not found in MedDRA dictionary Value for Body System or Organ Class Code (--BDSYCD) variable should be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2015 Value for --SOC not found in MedDRA dictionary Value for System Organ Class (--SOC) variable should be populated using a System Organ Class of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning
SD2016 Value for --SOCCD not found in MedDRA dictionary Value for System Organ Class Code (--SOCCD) variable should be populated using a System Organ Class Code of the MedDRA dictionary of a version specified in the define.xml AE Terminology Warning