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shareqc_sdtm20sdtm21_ds
PurposeTT
#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

A sequence of characters used by the sponsor to uniquely identify the study.



2DOMAINDomain AbbreviationChar
Identifier

C49558

A sequence of characters used by the sponsor to uniquely identify the study.

2-character abbreviation, which must be "TT".
3RSTGCDRepro Stage CodeChar
Topic
Not in human clinical trials

Short name of the repro stage, used for programming and sorting. Maximum 8 characters.
4RSTAGEDescription of Repro StageChar
Synonym QualifierRSTGCDNot in human clinical trials

The name of the repro stage.
5TTSTRLRule for Start of Repro StageChar
Rule
Not in human clinical trials

Expresses the rule for beginning the repro stage.
6TTENRLRule for End of Repro StageChar
Rule
Not in human clinical trials

Expresses the rule for ending the repro stage. Either TTENRL or TTDUR must be present for each repro stage.
7TTDURPlanned Duration of Repro StageCharISO 8601 durationTiming
Not in human clinical trials

Used when the rule for ending the repro stage is applied after a fixed duration.