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 and domains 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: |
3 | Tabulation and analysis standards for Product Description and Product Impact on Population Health use cases.- Product Design Parameters (PD)
- Tobacco Ingredients (IT)
- Non-Tobacco Ingredients (IN)
- Ingredient Quantities by Component (IQ)
| These datasets and domains are used to represent data that characterize tobacco products. Tabulation standards for product data are new to both CDISC and stakeholders. At present, these datasets and domains will be restricted to TIG v1.0 and withheld from SDTM v2.1 while stakeholders use the standards in practice. Experience with these standards will inform subsequent refinements if needed. Refinements, if any, will be incorporated into the next version of the TIG and the associated SDTM.
| | 3 | New dataset structures are not described in the ADaM | - contains an ADaM example woth a class of ADAM OTHER that is not based on USUBJID like all other datasets in the current ADaM
| | 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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