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Protocol Registration Training & Resources 

Trainings

DAIDS Protocol Registration System (DPRS) Training (required)

The DPRS eLearning module is a self-paced training which can be accessed via the DAIDS Learning Portal. First, log in to the DAIDS Learning Management System (LMS) with your user name and password. Then enter DPRS into the search field, and select the DPRS training course. If you do not have a DAIDS LMS Account you may request access using the link below.

WebLink DAIDS Learning Management System (LMS)
WebLink Request for LMS Account Access

DAIDS Protocol Registration Policy and Manual Training (highly recommended)

The Protocol Registration Policy and Manual eLearning module is a self-paced training which can be accessed via the DAIDS Learning Portal. First, log in to the DAIDS Learning Management System (LMS) with your username and password. Then enter “PR Policy and Manual” into the search field, and select the Protocol Registration: Policy and Manual Training course. If you do not have a DAIDS LMS Account you may request access using the link above.


Other DAIDS Protocol Registration Trainings

PPT DAIDS Protocol Registration Basic Training
November 2014
Doc_Icon_HTML5 Changes You Need to Know Question and Answer Session
Content in Adobe Flash format. (Download Adobe Flash Player).

Note : This training presents an overview of updates that were made for the 2012 Protocol Registration Manual, however, it continues to be relevant for the 2015 version.

Click below to request a training session:

QuickLinkTile_RequestTraining

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

  • DAIDS memo: Required Documentation of Risk/Benefit Category and Approval of Clinical Studies for Inclusion of Children by Institutional Review Boards/Ethics Committees Based on 45 CFR 46, Subpart D.
    PDF Required Documentation Based on 45 CFR 46
    October 2009

IBC Oversight of Research with Recombinant DNA


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

PRO Quick Reference Cards

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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. HHSN272201700014C, 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. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).