The DAIDS Protocol Registration Team (PRT) establishes internal procedures and processes for the DAIDS RSC Protocol Registration Office (PRO). DAIDS PRO receives and processes all protocol registration materials submitted by Clinical Research Sites (CRSs) participating in DAIDS-supported and/or -sponsored clinical trials.
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) or Approving Entity approvals and have provided to DAIDS all documentation pertaining to investigator qualifications and responsibilities that are required by I.C.H. requirements, 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 I.C.H., and U.S. Federal regulations.
Should you have any questions or need more information, please contacts the DAIDS Protocol Registration Team (PRT) at NIAIDOPCROPRTeam@niaid.nih.gov
Related Training Courses on the DLP
|Name||Description and Audience|
|DAIDS Protocol Registration System (DPRS)||Required training to access the DPRS. DPRS is an internet-based system that allows DAIDS CRSs to submit and track all regulatory documents submitted to the DAIDS PRO. DPRS provides DAIDS and CRSs with a unified centralized system that serves as the official information source for the PR process. Staff members who will use the DPRS to prepare, submit, and track protocol registration documents must take this training.|
|Protocol Registration: Policy and Manual Training||Overview of the DAIDS Protocol Registration Policy and Manual. It is highly recommended that staff members who will be working with site regulatory and protocol related documents take this training.|
DAIDS Protocol Registration Basic Training
DAIDS Protocol Registration Basic Training is a training that contains hands-on information for submitters of registration materials. It includes a broad overview of protocol registration and the DAIDS PRO. Additionally, it provides details on required documents for each submission and how to submit within DPRS.