The below documents describe the processes and parties involved in the lifecycle of a protocol, the DAIDS-defined study statuses and milestones, and processes for implementing protocol changes and Letters of Amendment (LOAs).
Protocol Development Lifecycle
DAIDS Study Statuses
DAIDS Protocol Change Process Policy
DAIDS-OPC-A15-POL-00018 - November 2022
- DAIDS Protocol Change Process Job Aid
DAIDS-OPC-A15-GUD-00008 - November 2022
For DAIDS SOPs and Policies, visit the DAIDS Clinical Research Policies page