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Click here for Protocol Registration FAQs

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)/Approving Entity 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. 


BulletGuidance Regarding DAIDS Deregistration ProcessPDF Document

BulletProtocol 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
Adobe PDF Document  Microsoft Word Form

BulletForm 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.
Adobe PDF Document

BulletFinancial Disclosure Form
Process for collection of Financial Disclosure Forms for all investigators and sub-investigators listed on Form FDA 1572.



  • DAIDS Financial Disclosure Guidance
MS-Word Document

  • Financial Disclosure Forms for ACTG
MS-Word Document

  • Financial Disclosure Form for HPTN
MS-Word Document

  • Financial Disclosure Form for IMPAACT
MS-Word Document

  • Financial Disclosure Form for MTN
MS-Word Document

BulletDAIDS 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
MS-Word Document  Adobe PDF Document

BulletElectronic Protocol Registration (EPR) Guidelines (April 2010) PDF Document

Bullet45 CFR Part 46 Letter PDF Document

BulletChildren in Research: 45 CFR 46 subpart DWeb Site Link

BulletDAIDS PRO Timelines PDF Document

BulletTranslation Confirmation Document (5/2012)Microsoft Word Form

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

BulletProtocol Registration at a Glance 2012PDF Document

BulletImplementation Plan for the Protocol Registration Policy and Manual, dated May 2012PDF Document

BulletDAIDS Protocol Registration Policy and Procedures Manual



  • Protocol Registration Policy, 04 May 2012, Version 4.0
Web Site Link



  • Protocol Registration Procedures Manual, May 2012, Version 2.0
Web Site Link



  • Summary of Changes to the DAIDS Protocol Registration Manual 2012
Adobe PDF Document



  • Protocol Registration Algorithm
Web Site Link


BulletDAIDS Protocol Registration TrainingWeb Site Link



  • Policy and Manual (highly recommended)
Web Site Link



    • Changes You Need to Know Question and Answer Session
Ten Minute Tour of the DAIDS RSC Website Document Flash Document Icon



  • DAIDS Protocol Registration System (DPRS) (required)
Web Site Link



    • DPRS Quick Reference Guide 
Adobe PDF Document



  • DAIDS Protocol Registration Communication Announcement, January 24, 2013  
Adobe PDF Document



  • DAIDS Learning Portal
Web Site Link

 

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