A known issue is a problem or concern with a CDISC standard that CDISC is aware of and is working actively to mitigate or resolve.
| Metadataspec |
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| Num | Issue | Description and Resolution |
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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 datasets for the TIG Product Description use case are not described the SDTM v2.1 metadata. These datasets are: Study Reference Datasets: - Environmental Storage Conditions (ES)
- Tobacco Product Identifiers and Descriptors (TO)
Special-Purpose Domains:
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| | 3 | Tabulation and analysis standards for Product Description and Product Impact on Population Health use cases. |
| | 4 | The Product Description analysis structure |
| | 5 | The REFERENCE data structure |
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References to "treatment" in CDASH and ADaM models
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