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: - 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 to allow time for stakeholders use the standards in practice. Experience with these standards will inform subsequent refinements if needed. |
RefinementsThe standards and refinements, if any, will be incorporated into the next version of the TIG and the associated version of SDTM.
| | 3 |
New dataset structures are not described in the ADaM | | The ADAM OTHER dataset structure for the TIG Product Description use case is non-subject based. | ADAM OTHER implemented for the TIG Product Description use case |
contains an ADaM example woth a class of ADAM OTHER that is not based on USUBJID like all other datasets in ADaM v2.1. Analysis standards for product data are new to both CDISC and stakeholders. At present, this implementation of ADAM OTHER will be restricted to TIG v1.0 and withheld from an associated version of ADaM to allow time for stakeholders use the standard in |
the current ADaMpractice. Experience with this standard will inform subsequent refinements if needed. The standards and refinements, if any, will be incorporated into the next version of the TIG and the associated version of ADaM. | | 4 | The |
Product Description analysis structure5| new REFERENCE dataset structure for the TIG Product Impact on Population Health use case is not described in the ADaM v2.1. | The REFERENCE data structure is designed to represent initial input parameters used in population modeling. This structure is new to both CDISC and stakeholders. At present, this structure will be restricted to TIG v1.0 and withheld from an associated version of ADaM to allow time for stakeholders use the standard in practice. Experience with this standard will inform subsequent refinements if needed. The standards and refinements, if any, will be incorporated into the next version of the TIG and the associated version of ADaM. |
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References to "treatment" in CDASH and ADaM models
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