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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDSIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
DSSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DSGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
DSREFIDReference IDChar
IdentifierInternal or external identifier.Perm
DSSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a Disposition page.Perm
DSTERMReported Term for the Disposition EventChar
TopicVerbatim name of the event or protocol milestone. Some terms in DSTERM will match DSDECOD, but others, such as "Subject moved", will map to controlled terminology in DSDECOD, such as "LOST TO FOLLOW-UP".Req
DSDECODStandardized Disposition TermChar

(NCOMPLT)(PROTMLST)(OTHEVENT)

Synonym QualifierControlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: "INFORMED CONSENT OBTAINED". There are separate codelists used for DSDECOD where the choice depends on the value of DSCAT. Codelist "NCOMPLT" is used for disposition events, codelist "PROTMLST" is used for protocol milestones, and codelist "OTHEVENT" is used for other events.Req
DSCATCategory for Disposition EventChar(DSCAT)Grouping QualifierUsed to define a category of related records.Exp
DSSCATSubcategory for Disposition EventChar

(DSSCAT)

Grouping QualifierA further categorization of DSCAT (e.g., "STUDY PARTICIPATION" when DSCAT = "DISPOSITION EVENT"). The variable may be subject to controlled terminology for other categories of disposition event records.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the event.Perm
DSDTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingCollection date and time of the disposition observation represented in ISO 8601 character format.Perm
DSSTDTCStart Date/Time of Disposition EventCharISO 8601 datetime or intervalTimingStart date/time of the disposition event in ISO 8601 character format.Exp
DSDYStudy Day of CollectionNum
TimingStudy day of collection of event relative to the applicant-defined RFSTDTC.Perm
DSSTDYStudy Day of Start of Disposition EventNum
TimingStudy day of start of event relative to the applicant-defined RFSTDTC.Exp

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
  • Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
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