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 Guidance for Implementing Protocol Changes
July 2018

LOA Flowchart
July 2013

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

Content last reviewed on 
July 16, 2018