...
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 | ||||
|---|---|---|---|---|---|---|
| 1.1 | 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) | |||
| 1.2 | Metadata Developer | Create concept maps | CMAPS | |||
| 1.3 | Clinical Expert | Review concepts maps | Review with clinical and/or relevant SMEs (if applicable) | |||
| 1.4 | Metadata Developer | Refine information requirements (deliverables) | Is this some kind of artifact that is shown to GGG? if not, what is it they review? | |||
| 1.5 | GGG Lead | GGG provides approval to move forward | ||||
| 1.6 | 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 | ||||||
| 2.1 | 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? | |||
| 2.2 | 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 | |||
| 2.3 | Project Team Lead | Concept 2 | ||||
| 2.4 | Project Team Lead | Concept 3 | ||||
| 2.5 | Project Team Lead | Concept 4 | ||||
| 2.6 | Project Team Lead | Concept 5 | ||||
| 2.7 | Project Team Lead | Concept 6 | ||||
| 2.8 | Project Team Lead | Concept 7 | ||||
| 2.9 | Project Team Lead | Concept 8 | ||||
| 2.10 | Project Team Lead | Concept 9 | ||||
| 2.11 | Project Team Lead | Concept 10 | ||||
| 2.12 | Project Manager | Final review of TAUG with Metadata Analyst | TAUGs are not currently in library, but it would be good to establish this now for when they do get added. This would actually be a final, since they would have been meeting every month, 3 months, etc. as necessary. | |||
| 2.13 | Project Manager | Schedule GGG review | ||||
| 2.14 | GGG Lead | GGG approves TAUG for Internal Review | Software Developer | Scrape and load to DEV | This indicates that there are no issues with structures | |