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.

Protocol Registration at a Glance
March 2016

Creating a New Submission in the DPRS Quick Reference Card
Version 1.1 - April 2016

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:

DAIDS RSC PRO Timelines
April 2010

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.

DAIDS Clinical Trial Application Submission Checklist
Version 1.0 – November 2018

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.

DAIDS Policy for Enrolling Children in Research
November 2015

45 CFR Part 46 - Protection of Human Subjects
July 2009

21 CFR Part 50 - Protection of Human Subjects
April 2015

IBC Oversight of Research with Recombinant DNA

NIH Office of Science Policy

Biosafety and Recombinant DNA Policy

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
April 2016

 

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