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| Step # | Role | Instructions |
|---|---|---|
| 1.0 | EVS Terminology Expert / Clinical TA Expert (s) | Gathers CRFs. Review public databases, regulatory guidelinesPerform a Public Database Search for existing TA Concepts. |
| 2.0 | Clinical TA Expert(s) | Refine scope. Identify network for clinical SMEs. |
| 3.0 | Project Manager | Review scoping materials. |
| 4.0 | Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert | Performs initial gap analysis. |
| 5.0 | ADaM SME | Holds ADaM assessment meeting if applicable. |
| 6.0 | Project Manager | Draft project charter and project plan. |
| 7.0 | Project Manager | Review entire scope package with Data Science representative including the expected required Wiki structures. |
| 8.0 | Project Manager | Submit scoping package to TAPSC/TLC. Plans kick-off activities. |
| 9.0 | TAPSC/TLC | Receives Project Charters(TAs) for approval to proceed with the next stage of the development process. |
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