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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.



2DOMAINDomain AbbreviationChar
Identifier

C49558

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

2-character abbreviation, which must be "DI".
3SPDEVIDSponsor Device IdentifierChar
Identifier



Sponsor-defined identifier for the device.
4DISEQSequence NumberNum
Identifier



Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID).
5DIPARMCDDevice Identifier Element Short NameChar
Topic



Short name of the identifier characteristic of the device.
6DIPARMDevice Identifier Element NameChar
Synonym QualifierDIPARMCD


Name of the identifier characteristic of the device.
7DIVALDevice Identifier Element ValueChar
Result Qualifier



Value for the parameter.
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