What does DAIDS/RSC Protocol Registration Office do?
The DAIDS Protocol Registration Office (PRO) at the RSC receives and processes all protocol registration materials submitted by sites participating in DAIDS-supported and/or sponsored clinical trials. They work closely with the DAIDS Protocol Registration Team (PRT) to establish internal procedures and processes.
The DAIDS protocol registration process verifies that sites have received the necessary Institutional Review Board (IRB)/ Ethics Committee (EC) and other applicable Regulatory Entity (RE)/Approving Entity approvals and have provided to DAIDS all documentation pertaining to investigator qualifications and responsibilities that are required by the U.S. federal regulations and the National Institutes of Health (NIH). The DAIDS protocol registration process also verifies that site-specific informed consent forms contain the necessary information to comply with U.S. federal regulations.