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ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-Recorded Training Video

U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration (FDA)•Jun 4, 2026

Why It Matters

Non‑compliance with ClinicalTrials.gov mandates can trigger hefty penalties, loss of federal funding, and erode public trust, directly affecting an institution's research viability and reputation.

Key Takeaways

  • •ACTs must register within 21 days of first participant enrollment.
  • •Results must be posted within one year after primary completion date.
  • •Informed consent must include exact FDA‑mandated trial‑listing statement.
  • •Failure triggers pre‑notice, then notice, leading to penalties or grant loss.
  • •Academic centers need coordinated support to meet ongoing update deadlines.

Summary

The video is a pre‑recorded training for academic medical centers on ClinicalTrials.gov registration and results reporting. FDA and NIH experts outline legal obligations, the historical evolution of the registry, and the roles of the National Library of Medicine, FDA, and study sponsors. Key points include the definition of an Applicable Clinical Trial (ACT), the 21‑day registration deadline after enrolling the first subject, and the one‑year deadline after the primary completion date for posting results. Sponsors must embed a precise FDA‑mandated statement in informed‑consent forms, certify compliance via FDA Form 3674, and keep records current with annual and rapid‑update requirements. Jennifer Vong, an FDA reviewer, explains the enforcement workflow: a pre‑notice of non‑compliance, a 30‑day voluntary correction window, followed by a formal notice and potential civil penalties, grant withholding, or even criminal action. The presentation emphasizes that even terminated trials remain subject to reporting. For academic institutions, the training underscores that compliance is a collective responsibility requiring dedicated resources, institutional coordination, and ongoing monitoring. Failure jeopardizes public trust, research integrity, and funding streams, making proactive adherence essential for both scientific advancement and regulatory standing.

Original Description

This required pre-recorded training video can be completed at your own pace prior to registering for any or all of the live panel sessions. Upon completion of the pre-recorded training, you can submit any questions you have about ClinicalTrials.gov registration and reporting via the registration process to attend a live virtual session with a panel of experts. The panel will use your questions to guide the discussion and provide relevant, practical answers. The live panel sessions are designed to build upon the information presented in the on-demand video.
Timestamps
00:05 – ClinicalTrials.gov Registration and Reporting: What You Need to Know
06:16 – ClinicalTrials.gov: Legal Requirements
19:43 – Where and How to Report Trials for Posting on ClinicalTrials.gov
Speakers:
Laurie Muldowney, M.D.
Deputy Director
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA
Jennifer Vuong, Pharm.D.
Consumer Safety Officer
Compliance Enforcement Branch
Division of Enforcement and Postmarketing Safety
OSI | OC | CDER | FDA
Anna M. Fine, Pharm.D., M.S.
Director
National Library of Medicine | National Institutes of Health
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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