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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 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

The SDTM v2.1 refers to model implementers as "sponsors".

The TIG implements the SDTM and the TIG v1.0 references the SDTM v2.1. To date the SDTM has referred those who implement the model as "sponsors"; a term which is not inclusive of applicants. Refinements to language will be considered for a future version of the SDTM post TIG publication. In the interim, the term "sponsor" is considered equivalent to "applicant" when using this guide with the SDTM v2.1.

3

New datasets and domains for the TIG Product Description use case are not described in 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 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.


4TIG 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.

5The 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.

6The 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 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.

7Some controlled terminology terms and codelists are referenced in the TIG but will not be published at the time of TIG publication. 

Some controlled terminology terms and codelists will be published for use after TIG publication and are anticipated to be released end-September 2024. Codelists that will not be published at the time of TIG publication are:

Product Description Tabulation (SDTM):

  • SPECPT (Tobacco Product Testing Specimen Type)
  • TPACN (Action Taken with Tobacco Product)
  • IGDCMPLX (Ingredient Complexity Response)
  • IQCAT (Category of Ingredient Quantities by Component)
  • PDPARMCD (Tobacco Product Design Parameters Code)
  • PDPARM (Tobacco Product Design Parameters Name)
  • PTTESTCD (Tobacco Product Testing Test Code)
  • PTTEST (Tobacco Product Testing Test Name)
  • PTCAT (Category of Tobacco Product Testing)
  • TOCAT (Category of Tobacco Products)

Nonclinical Tabulation (SEND):

  • LVLDSCRS (Reference ID Level Description Response)
  • GTTEST (Genetic Toxicology In vitro Test Name)
  • GTTESTCD (Genetic Toxicology In vitro Test Code)

Product Impact on Population Health Analysis (ADaM):

  • INPRM (Input Parameter)
  • STRATA (Analysis Stratum)
  • TBUTRS (Tobacco Use Transition Response)
  • TPUSRS (Tobacco Product Use Status Response)
  • TPCATRS (Tobacco Product Category Response)

  • No labels