SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

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#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

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "TP".
3RPATHCDPlanned Repro Path CodeChar
Topic
Not in human clinical trialsC170503A short sequence of characters that represents the planned reproductive path to which the subject was assigned.Limited to 20 characters. Should be populated in Demographics when repro paths have been defined in this domain.
4RPATHDescription of Planned Repro PathChar
Synonym QualifierRPATHCDNot in human clinical trials

Name of the planned repro path.
5TPSTGORDOrder of Repro Stage within Repro PathNum
Timing
Not in human clinical trials

Number that gives the planned order of the repro stage within the repro path.
6RSTGCDRepro Stage CodeChar
Topic
Not in human clinical trials

Short name of the repro stage used for programming and sorting. Maximum 8 characters. The values of RSTGCD used in the Trial Paths dataset must match values for the same repro stage in the Trial Stages dataset.
7RSTAGEDescription of Repro StageChar
Synonym QualifierRSTGCDNot in human clinical trials

The name of the repro stage.
8TPBRANCHBranchChar
Rule
Not in human clinical trials

Conditions subjects meet, occurring at the end of a repro stage, which cause a repro path to branch off from another repro path.
9RPHASERepro PhaseChar
Timing
Not in human clinical trials

Name of the reproductive phase with which this repro stage of the repro path is associated.
10RPRFDYRepro Phase Start Reference DayNum
Timing
Not in human clinical trials

Sponsor protocol-defined first day of repro phase. Should be zero or 1.
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