At this stage in the process, a Therapeutic Area Specification should be drafted. In collaboration with the FDA, a template has been developed to show the different versions of the SDTM and how they relate to domains and variables contained in TA User Guides. The specifications comprise of five worksheets in an Excel workbook:
- Read Me – Contains information on how to read the other worksheets
- Summary – Contains a Table of Contents for the User Guide annotated with information on domains and variables used
- Domains – Contains information on domains used and their status with respect to different versions of the SDTMIG
- Variables – Contains information on variables used and their status with respect to different versions of the SDTM
- Known Issues – Contains a list of modeling issues noted in the TA User Guide
Process:
A TA specification is required for each TA User Guide. Teams should begin drafting the TA Specification during Stage 2 (Development of Draft Standards). The modeling, metadata and examples should be approved prior to drafting the TA Specification.
TA Specifications can be compiled either by the TA team, if there is an experienced resource, or by a designated resource. This will be determined on a case by case basis. A Wiki page that tracks specification priority and development can be found here: TA Specification.
Review Cycles:
Draft TA Specifications may be included in the package that goes out for Internal Review, but there is no requirement to do so.
The TA Specification may be provided with the draft TA User Guide at Public Review to aid reviewers. There is no requirement for public comment on the TA Specification; however, if there are public comments they should be addressed. Any updates made to the TA User Guide from the Public Review would also be made in the TA Specification, as needed.
Delivery to FDA:
FDA should be notified when a TA Specification is posted along with the new standard package on the CDISC website.
Publication:
TA specifications will be posted with the approved TA User Guide and the Comment Resolution Spreadsheet on the CDISC website.
Dependencies
The processes of developing terminology and questionnaires should be carried out in parallel to standards development. Terminology not finalized at this stage should be documented in the draft as “under development.” Status of Questionnaires permission state is recorded in the appendix of the standard.
TA Projects:
It is important that issues related to the SDTM be resolved at this stage with the SDS team. CDASH and ADaM should be considered, but may not be included in the first version of the draft TA User Guide. At the very least, a minimum set of statistical endpoints for ADaM should be available, even if example datasets are not developed.
Foundational Projects:
It is important that issues related to other foundational standards be resolved at this stage with the appropriate foundational team.