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

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
RDOMAINRelated Domain AbbreviationChar(DOMAIN)IdentifierAbbreviation for the domain of the parent record(s).Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Exp
IDVARIdentifying VariableChar
IdentifierName of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID.Req
IDVARVALIdentifying Variable ValueChar
IdentifierValue of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here.Exp
RELTYPERelationship TypeChar(RELTYPE)Record QualifierIdentifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. Used only when identifying a relationship between datasets).Exp
RELIDRelationship IdentifierChar
Record QualifierUnique value within USUBJID that identifies the relationship. All records for the same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the applicant chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records.Req

Assumptions

There are no additional RELREC-specific assumptions; all are included in Section 2.8.5.2, Relating Subject Records and Datasets. See also Section 2.6, Guidance for Datasets, Tabulation Datasets table Row 9.

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