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
January 2017
DAIDS Study Statuses
September 2015
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
LOA Flowchart
July 2013
For DAIDS SOPs and Policies, visit the DAIDS Clinical Research Policies page
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