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ClinicalTrials.gov Results Database Train-the-Trainer Workshop Materials


This workshop is led by ClinicalTrials.gov staff and provides training to key personnel who are involved in submitting results to ClinicalTrials.gov for their academic organization.

The workshop topics include: the basic organizational principles of the Protocol Registration and Results System (PRS) results modules, step-by-step data entry instructions for common study designs, Results Review Criteria, and navigating the ClinicalTrials.gov website help resources.

The workshop also provides an overview of key laws and policies, including the registration and results submission requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and its implementing regulations (42 CFR Part 11).

This page links to course materials from August 2021. To learn about future workshops, please see the ClinicalTrials.gov web site.

 

Overview of Clinical Trial Transparency and Disclosure Landscape


Protocol Registration and Results System (PRS) Overview

Clinical Trials Registration & Reporting


PRS Results Module Introductions



For more about submitting studies to the ClinicalTrials.gov system, see the ClinicalTrials.gov web site.

Last Reviewed: May 10, 2024