Food and Drug Administration’s Oversight of the Submission of Applicable Clinical Trial Results to ClinicalTrials.gov

OBJECTIVE

The Food and Drug Administration (FDA) is responsible for ensuring that results of applicable clinical trials are reported to ClinicalTrials.gov within 1 year of the completion date. Clinical trials are vital to human medical advances because they help determine whether interventions are safe and effective, and it is essential to have transparency with the public about clinical trial results. FDA monitors compliance with reporting requirements through various methods, including evidence collected during inspections conducted as part of FDA's Bioresearch Monitoring Program. FDA may notify a responsible party that has not met reporting requirements and allow 30 days to remedy the noncompliance. If a responsible party remains noncompliant, FDA may initiate a corrective action, including seeking civil monetary penalties. We will conduct an audit to determine whether FDA notified responsible parties of noncompliance with the requirement to submit the results of applicable clinical trials in accordance with Federal requirements.

TIMELINE

• January 2, 2024
  Announced
• Today
  Office of Audit Services In-Progress
• Est FY2026
  Estimated Fiscal Year for Project Completion

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