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 Team Lead | Project Team analyzes concept list | Examine concepts and consider what specific content is needed as part of the final standards product. Is this different than what is in Stage 1 analysis? |
| Project Team 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 - Creates sample data to improve understanding of all key concepts. CDASH, SDTM, ADaM and they'd all flow through (sometimes no ADaM ). Sometimes just text, list of lab tests |
| Project Team Lead | Concept 2 | |
| Project Team Lead | Concept 3 | |
| Project Team Lead | Concept 4 | |
| Project Team Lead | Concept 5 | |
| Project Team Lead | Concept 6 | |
| Project Team Lead | Concept 7 | |
| Project Team Lead | Concept 8 | |
| Project Team Lead | Concept 9 | |
| Project Team Lead | Concept 10 | |
| Project Manager | TAUGs are not currently in library, but it would be good to establish this now for when they do get added. | |
Project Manager | Schedule GGG review | |
GGG Lead | GGG approves TAUG for Internal Review | |
| Software Developer | This indicates that there are no issues with structures | |