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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.
| 1.0 |
|
|---|
| EVS Terminology Expert / Clinical TA Expert (s) | Gathers CRFs, perform a Public Database Search for existing TA Concepts |
.202.1 |
|
| Clinical TA Expert(s)/Project Manager | Verifies that all applicable regulatory guidance are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document |
.30 |
|
| 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. |
5.06.0 |
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| ADaM SME | Holds ADaM assessment meeting if applicable. |
7.0 | .80 |
|
| Project Manager | Review the entire scope package with the Data Science representative including the expected required Wiki structures. |
9.0 |
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| Project Manager | Submit scoping package to TAPSC/TLC and plans kick-off activities. |
10.0 |
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| 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. |
|
|
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| Add agreed upon scoping items to development |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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