DAIDS Regulatory Compliance Center - Protocol Registration


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What does DAIDS/RCC Protocol Registration do?

The process of completing and submitting the informed consent, IRB/EC approval letter, FDA 1572 Form, and Principal Investigator C.V. is called Protocol Registration. Protocol registration may occur more than once during the course of the protocol. Subsequent protocol registrations are called amendment registrations.

	Protocol Registration Presentations

	DAIDS Protocol Registration System (DPRS)
	DPRS Features and Enrollment Process

	DPRS Enrollment and Training Web Site

	DPRS Training Presentation

	DPRS Quick Reference Guide

	Policy and Procedures Manual - August 2004
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	Non-Highlighted for optimum printing

	Checklist This is a mandatory document and must be submitted with all protocol registration materials.
	Instructions for Completing the Checklist

	Protocol Registration Checklist - August 2004

	FDA Form 1572 for Investigator Registration A protocol specific Form FDA 1572 must be submitted with each new protocol registration for protocols conducted under an IND.
	Instructions for completing the FDA Form 1572

	FDA Form 1572 The Form FDA 1572 has not been updated by the FDA as of yet. Please continue to use the Form FDA 1572 that has an expiration date of 05/31/2009. Once the FDA updates the Form FDA 1572 it will be posted on the RCC web site.

	Investigator of Record Agreement A protocol specific Investigator of Record Agreement must be submitted with each new protocol registration for protocols NOT conducted under an IND.
	Instructions for completing Investigator of Record Agreement Form

	Investigator of Record Agreement Form

	Local Language Informed Consent Verification Statement

	Request for Disapproval Reversal

	Electronic Protocol Registration Guidelines (January 2005)

	Children in Research: 45 CFR 46 subpart D

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