| Num | Issue | Description and Resolution |
|---|
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)
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-51 |
|---|
|
- 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.
|
| 3 | TIG 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 the ADaM are implemented by the TIG with labels updated to reflect products and product exposure. Updates to labels in the ADaM will be considered as part of the next version of the TIG and the associated version of ADaM. |
| 4 | 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 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 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. |
| 5 | The 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. |