The DAIDS Protocol Registration Team (PRT) and the DAIDS RSC Protocol Registration Office
The DAIDS Protocol Registration Team (PRT) is a Team within OPCRO responsible for managing the Protocol Registration (PR) process, which includes oversight of the DAIDS RSC PRO.
The process of completing and submitting the site-specific informed consent, IRB/EC approval letter, FDA 1572 Form, and Investigator of Record CV is called Protocol Registration. Protocol Registration may occur more than once during the course of the protocol. Subsequent protocol registrations are called amendment registrations.
The DAIDS RSC Protocol Registration Office (PRO) works closely with DAIDS PRT and provides support by reviewing and tracking all required clinical site regulatory documents for all protocol versions at each Clinical Research Site to ensure that all documents needed to fulfill the study sponsor’s regulatory obligations relating to protocol registration are reviewed for completeness and accuracy within the specified timeline set up by the sponsor, as stated in the DAIDS Protocol Registration Policy and Procedures Manual, and in compliance with 21 CFR 50, 21 CFR 56, and 45 CFR 46. The DAIDS RSC PRO also plans and conducts trainings on protocol registration procedures as requested by DAIDS.