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A known issue is a problem or concern with a CDISC standard of which CDISC is aware and is working actively to mitigate or resolve.

NumIssueDescription and Resolution

1

Data collection variable definitions are in draft.

Draft definitions for data collection variables TOBA-371 - Getting issue details... STATUS are provided in the DRAFT Collection Definition column as part of  the metadata tables in Section 2.7.6, 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 in the SDTM v2.1 metadata. TOBA-747 - Getting issue details... STATUS 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 to allow time for stakeholders use the standards in practice. Experience with these standards 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 SDTM.


3TIG ADaM variable labels reference products and product exposures and do not reference treatments. This is a change to a subset of variable labels in the ADaM. 

The concept of exposure to products is applicable to tobacco product data, but exposure is not considered to be treatment or for the purpose of treatment. Where appropriate, variables from ADaM are implemented in the TIG with labels updated to reflect products and product exposure. Updates to labels in ADaM will be considered as part of the next version of the TIG and the associated version of ADaM.

4The 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, unlike all other datasets in ADaM v2.1, is not based on USUBJID. 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 to 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.

5The new REFERENCE dataset structure for the TIG Product Impact on Population Health use case is not described in  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 TOBA-372 - Getting issue details... STATUS . 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.
6The following controlled terminology codelists are referenced in the TIG but will not be published at the time of TIG publication. 

The following controlled terminology codelists will not be published at the time of TIG publication. 

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Codelists will be published for use post TIG publication and are anticipated to be release in 2024.

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