...
| Role | Responsibilities |
|---|---|
| Project Manager | Prepares the scoping package for submission. Once the Project Charter is approved, Project Manager posts it in the team space on the CDISC Wiki. |
| Project Team | |
| Clinical TA Expert(s) | Ensures the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking. Completes the literature review for the therapeutic area and working with the Project Manager and the ADaM Representative to compile a reference list. |
| EVS Terminology Expert | |
| ADaM SME | |
| TAPSC/TLC | Receives Project Charter(TAs) for approval to proceed with the next stage of the development process. |
...