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| Role | Responsibilities | |
|---|---|---|
| Project Manager | ||
| 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. | |
| EVS Terminology Expert | ||
| ADaM SME | Program Manager | |
| TAPSC/TLC | Receives Project Charter(TAs) for approval to proceed with the next stage of the development process. |
Instructions
Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.
| Step # | Role | Instructions |
|---|---|---|
| 1.0 | EVS Terminology Expert / Clinical TA Expert (s) | Gathers CRFs. Reviews public databases, regulatory guidelines. |
| 2.0 | Clinical TA Expert(s) | Refines scope. Identifies network for clinical SMEs. |
| 3.0 | Project Manager | Reviews scoping materials. |
| 4.0 | Clinical TA Expert(s) / EVS Terminology Expert / Statical Statistical Analysis Expert | Performs initial gap analysis. |
| 5.0 | ADaM SME | Holds ADaM assessment meeting if aplicableapplicable. |
| 6.0 | Project Manager | Drafts project charter and project plan. |
| 7.0 | Project Manager | Submit scoping package to TAPSC/TLC. Plans kick-off activities. |
| 7.1 | TAPSC/TLC | Receives Project Charters(TAs) for approval to proceed with the next stage of the development process. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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