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 |
|---|---|---|
Project Team | ||
QRS Representative | ||
QRS Representative / Clinical Expert | ||
Metadata Developer | Model and develop biomedical concepts | |
Metadata Developer (Concept Developer) | ||
Clinical Expert | Review concepts maps with clinical and/or relevant SMEs (if applicable) | |
Metadata Developer | ||
SDTM Expert / SDS Team | ||
Metadata Developer | Refine information requirements (deliverables) | |
Clinical Expert / Clinical SMEs | ||
Project Team | " | |
Project Manager | ||
Project Team | " | |
GGG (Global Governance Group) | GGG Approval to move forward | |
| Project Manager | Update project information and hold project review. | |
| Stage 2 – Development of Draft Standards | ||
Metadata Developer | ||
Metadata Developer / SDTM Expert | ||
Metadata Developer / CDASH Representative | ||
TA Statistical Programmer ADaM Expert | ||
Metadata Developer | ||
| Metadata Developer | ||
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 | |
Technical Writer Metadata Developers and Concept Modelers | ||
Clinical TA Expert / Medical Writer | ||
Concept Developer | ||
TA Team | ||
Project Manager | ||
Project Manager | ||
Project Manager | ||
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 | |