Tip of the Week Archive

For Applicable Clinical Trials (ACTs and pACTs), basic registration and results information is required to be submitted to ClinicalTrials.gov in a timely manner. When these legal requirements are not met, the FDA has the authority to take enforcement action.

FDA announced in a bulletin on April 28, 2021 confirming that it has issued its first Notice of Noncompliance to a responsible party for failing to submit required results data to ClinicalTrials.gov. The Notice, issued to Acceleron Pharma, Inc., has been posted to FDA’s website. The Notice of Noncompliance gives Acceleron 30 days to submit the required results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.

In FDA’s announcement, they noted that the agency has sent more than 40 Pre-Notices of Noncompliance to date related to ClinicalTrials.gov violations. If a Pre-Notice is received, the responsible party generally has 30 days to address the noted compliance violations before an official Notice of Noncompliance is issued.

These new enforcement actions indicate an increase in risk to responsible parties and record owners with ClinicalTrials.gov compliance issues. If you have a record that is out of compliance (e.g. for late or missing results information), or if you need to register a record on ClinicalTrials.gov, contact clinicalresearchsupportcenter@ucdenver.edu.