...
| Step # | Role | Instructions |
|---|---|---|
| 1.0 | EVS Terminology Expert / Clinical TA Expert (s) | Gathers CRFs, perform a Public Database Search for existing TA Concepts. |
| 2.0 | Project Team | Ensure applicable regulatory guidance and requirements are taken into account. |
| 2.1 | Clinical TA Expert/Project Manager | Verifies that all applicable regulations are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document. |
| 3.0 | Clinical TA Expert(s) | Identifies the appropriate core concepts and that the standards under development are aligned with current medical practice and thinking. |
| 4.0 | Project Manager | Review scoping materials. |
| 5.0 | EVS Terminology Expert | Performs Controlled Terminology Gap Analysis. |
| 6.0 | ADaM SME | Holds ADaM assessment meeting if applicable. |
| 7.0 | Project Manager | Draft project charter and project plan. |
| 8.0 | Project Manager | Review entire scope package with Data Science representative including the expected required Wiki structures. |
| 9.0 | Project Manager | Submit scoping package to TAPSC/TLC and plans kick-off activities. |
| 10.0 | TAPSC/TLC | Receives Project Charters(TAs) for approval to proceed with the next stage of the development process. |
| 11.0 | Project Manager | Posts Project Charter in the team space on the CDISC Wiki. |
...