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Registering a Site to a Protocol

Each CRS will complete the protocol registration process for all clinical research supported and/or sponsored by DAIDS that is reviewed by DAIDS Scientific Review Committees, namely the Prevention Sciences Review Committee (PSRC) and the Clinical Sciences Review Committee (CSRC), if it is determined that protocol registration is required. Upon receiving final IRB/EC and other applicable RE/Approving Entity approval(s), the CRS will submit all required registration documents to the DAIDS RSC PRO via the DPRS.

PDF Protocol Registration at a Glance 
March 2016
PDF Creating a New Submission in the DPRS Quick Reference Card
Version 1.1 - April 2016
PDF Protocol Registration Checklist

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

Alternate format(s) available:
Word Protocol Registration Checklist
April 2010
PDF DAIDS RSC PRO Timelines
April 2010
PDF Electronic Protocol Registration (EPR) Guidelines
April 2010
The EPR is an alternate way CRSs can submit registration materials via email to the DAIDS RSC PRO if they encounter problems when trying to submit registration materials through the DPRS.

Resources

Enrolling Children in Clinical Research


Per the DAIDS Policy for Enrolling Children (including Adolescents) in NIAID (DAIDS)-supported and/or -sponsored Human Subject Clinical Research, for research studies including children or adolescents, DAIDS requires documentation of the IRB/EC designation of the pediatric risk or benefit category from the U.S. Federal regulations, 45 CFR 46.404-407 & 21 CFR 50.51-54 and IRB/EC approval for involvement of children based on the determination specified by that category.

PDF DAIDS Policy for Enrolling Children in Research
November 2015
WebLink 45 CFR Part 46 - Protection of Human Subjects
July 2009
WebLink 21 CFR Part 50 - Protection of Human Subjects
April 2015

IBC Oversight of Research with Recombinant DNA


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

For more information, see the Protocol Registration process FAQs.


    QuickLinkTile_FAQs_ProtocolRegistration
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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).