RELSPEC Dataset

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

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 LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

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



2USUBJIDUnique Subject IdentifierChar
Identifier

C69256

A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.



3REFIDReference IDChar
Identifier

C82531A sequence of characters used to uniquely identify a source of information.

4SPECSpecimen TypeChar
Variable QualifierREFID
C70713The type of sample material taken from a biological entity.

5PARENTSpecimen ParentChar
Identifier



Identifies the REFID of the parent of a specimen to support tracking its genealogy.
6LEVELSpecimen LevelNum
Variable QualifierREFID


Identifies the generation number of the sample where the collected sample is considered the first generation.

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