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.

DAIDS Learning Management System (LMS)

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

DAIDS Protocol Registration Basic Training
November 2014

Resources

Enrolling Children in Clinical Research

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

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

Clinical Trial Applications

DAIDS Clinical Trial Application Submission Checklist
Version 1.0 – November 2018

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

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