ClinicalTrials.gov: Essentials for Academic Medical Centers
Join the FDA for a virtual training that provides guidance for staff at academic medical centers on meeting federal requirements for clinical trial registration and results reporting on ClinicalTrials.gov. Experts from multiple U.S. Food and Drug Administration (FDA) centers, including CDER, CDRH, OCLP, and CBER, as well as the National Library of Medicine (NLM) within the National Institutes of Health (NIH), will address frequently asked questions related to regulatory obligations and the ClinicalTrials.gov Protocol Registration and Results System (PRS).
The training consists of a self-paced, pre-recorded module followed by optional live panel sessions that expand on key concepts and allow participants to engage directly with subject matter experts. Attendees are encouraged to submit questions in advance to help guide discussion during the panels.
Key components include:
- A required on-demand video covering foundational topics and regulatory expectations
- Live virtual panel sessions focused on practical applications and participant questions
- Opportunities to gain clarity on when and how to register studies and report results
Intended Audience:
- Academic Medical Centers
- ClinicalTrials.gov administrators
- Office of Clinical Research
- Academic researchers
- Sponsor-investigators
- Principal investigators
Topics Covered:
- ClinicalTrials.gov Registration and Results Reporting Requirements
- Common Compliance Pitfalls and Corrective Actions
- Center-Specific Guidance from CDER, CBER, and CDRH
- Features of the Protocol Registration and Results System (PRS)
- Expert Tips for Protocol Registration and Results Submission
- Available Tools and Resources
By completing both portions of the training, participants will gain a clearer understanding of ClinicalTrials.gov requirements and approaches for accurately and timely sharing clinical trial information with the public.
Visit the event page for more information.