The scope of each project must be approved by the appropriate governance committee prior to beginning Stage 1. The Project Manager prepares the scoping package for submission. The scoping package includes the following documents:
- Draft Project Charter
- Draft Project Plan
- Scoping Checklist
- Concept Listing Spreadsheet
- Initial Gap Analysis
- Documentation of input from FDA and resolutions (spreadsheet)
- List of Key Medical and Regulatory References
- Team Member List