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Metadataspec
NumIssueDescription and Resolution

1

Data collection variable definitions are in draft.

Draft definitions for data collection variables are provided in column DRAFT Collection Definition as part of metadata tables in Section x.x, Metadata for Individual Health. Draft definitions are in development as part of a separate initiative and, once finalized, will be updated in a future version of the TIG.

2

New domains datasets for the TIG Product Description use case are not in described the SDTM v2.1 metadata. These datasets are:

Study Reference Datasets:

  • Environmental Storage Conditions (ES) 



3Tabulation and analysis standards for Product Description and Product Impact on Population Health use cases.
4The Product Description analysis structure
5The REFERENCE data structure

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