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.
| Accountable | TAUG | Comments |
|---|---|---|
| Metadata Developer | Analyze concept list requirements | Based on concept list, do we need a diagram Do we need to explain further If yes, start CMAPS (1 or more) |
Metadata Developer | Create concept maps | CMAPS |
Clinical Expert | Review concepts maps | Review with clinical and/or relevant SMEs (if applicable) |
Metadata Developer | Refine information requirements (deliverables) | Is this some kind of artifact that is shown to GGG? if not, what is it they review? |
GGG Lead | GGG provides approval to move forward | |
| Project Manager | Update project information and hold project review. | What is this? Is this the project kickoff with team? |
| Stage 2 – Development of Draft Standards | ||
| Project Lead | Concept 1 | For each concept, create Content - Examine concepts and consider what specific content is needed as part of the final standards product. Examples - CDASH, SDTM, ADaM and they'd all flow through (sometimes no ADaM ). Sometimes just text, list of lab tests |
| Concept 2 | ||
| Concept 3 | ||
| Concept 4 | ||
| Concept 5 | ||
| Concept 6 | ||
| Concept 7 | ||
| Concept 8 | ||
| Concept 9 | ||
| Concept 10 | ||
Project Team | Examine concepts and consider what specific content is needed as part of the final standards product. | |
| Metadata Developer | Creates sample data to improve understanding of all key concepts | |
TA Team | ||
Project Manager | Add to GGG schedule | |
Global Governance Group | GGG approve TAUG for Internal Review | |
| Software Developer | This indicates that there are no issues with structures | |