Design and development
- Protocol preparation
- SOP identification or development
- Partner identification
- Project management planning
Approvals, permissions, and agreements
- Submissions to oversight bodies
- Agreements for data sharing, material transfer, etc.
Participant screening and enrollment
- Data capture
- Study team monitoring plus preparation of reports for other monitoring and oversight bodies
Data preparation, analysis and dissemination
- Data quality review and cleaning
- Scheduled and exploratory analyses
- Final reports
- Dissemination
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