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.



2DOMAINDomain AbbreviationChar
Identifier

C49558An abbreviation for a collection of observations, with a topic-specific commonality.2-character abbreviation, which must be "TE".
3ETCDElement CodeChar
Topic



ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.
4ELEMENTDescription of ElementChar
Synonym QualifierETCD


The name of the element.
5TESTRLRule for Start of ElementChar
Rule



Expresses the rule for beginning the element.
6TEENRLRule for End of ElementChar
Rule



Expresses the rule for ending the element. Either TEENRL or TEDUR must be present for each element.
7TEDURPlanned Duration of ElementCharISO 8601 durationTiming



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