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 Portal (DLP) 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 Learning Portal account you may request access using the link below.
Request for DLP Account Access via Login.gov
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 (DLP). First, log in to the DLP 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 DLP account you may request access using the link above.
Other DAIDS Protocol Registration Trainings
DAIDS Protocol Registration Basic Training
November 2014
DAIDS Protocol Registration Policy and Manual Training 2019 - PowerPoint
August 2020
Resources
Enrolling Children in Clinical Research
DAIDS Policy for Enrolling Children in Research
October 2022
45 CFR Part 46 - Protection of Human Subjects
July 2009
21 CFR Part 50 - Protection of Human Subjects
April 2015
Required Documentation for Pediatric Risk/Benefit Category 45 CFR 46.406 and 46.407
April 2019
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.
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 2024
Clinical Trial Applications
Clinical Trial Application Submission Guidance
Version 1.0 – November 2018
Signature Requirements
Signature Requirements Guidance
Version 1.0 – November 2018
PRO Quick Reference Cards
Protocol Registration at a Glance Quick Reference Card
January 2019
Creating a New Submission in the DPRS Quick Reference Card
Version 1.1 - April 2016
Pediatric Risk Category Report Instructions
How to Retrieve Pediatric Risk Category Report from DAIDS NCRMS
Version 1.0 - November 2019