You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 5 Next »

Description

A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets.


Specification

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



  • No labels