Developing Protocols

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

LOA Flowchart

July 2013

For DAIDS SOPs and Policies, visit the DAIDS Clinical Research Policies page

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