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SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0

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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.



2POOLIDPool IdentifierChar
Identifier

C117053

A sequence of characters used to uniquely identify a group of subjects that have been pooled together.

Used to identify a result that is not assignable to a specific subject.
3USUBJIDUnique 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.



4APIDAssociated Persons IdentifierChar
Identifier



Identifier for a single associated person, a group of associated persons, or a pool of associated persons.
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