DAIDS Regulatory Support Center - Protocol Registration


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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) 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.

	DAIDS Protocol Registration System (DPRS)

	DPRS Training Presentation

	DPRS Quick Reference Guide

	Protocol Registration Checklist This document must be submitted with each submission made through the electronic protocol registration (EPR) mailbox to the DAIDS PRO.

	Protocol Registration Checklist - April 2010

	Form FDA 1572 for Investigator Registration A protocol specific Form FDA 1572 must be submitted with each initial protocol registration submission for protocols conducted under an IND.

	Form FDA 1572 The Form FDA 1572 has been updated and is posted here. Use this Form FDA 1572, although it has an expiration date of 5/31/2009. When the FDA updates the Form FDA 1572 with a new expiration date it will be posted on the RSC web site.

	DAIDS Investigator of Record (IoR) Form A protocol specific DAIDS IoR Form must be submitted with each initial protocol registration submission for protocols NOT conducted under an IND.

	DAIDS IoR Form

	Electronic Protocol Registration (EPR) Guidelines (April 2010)

	Children in Research: 45 CFR 46 subpart D

	DAIDS PRO Timelines

	Translation Confirmation Document

	Institutional Biosafety Committee (IBC)/ Recombinant DNA Advisory Committee (RAC) Guidance

	Protocol Registration at a Glance

	Implementation Plan for the Protocol Registration Policy and Manual

	DAIDS Protocol Registration Policy and Procedures Manual

	Protocol Registration Policy, 26 March 2010, Version 3.0

	Protocol Registration Procedures Manual, March, 2010

	Summary of Changes to the DAIDS Protocol Registration Manual 2010

	Protocol Registration Algorithm

	Protocol Registration Live Webinar Training Sessions

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