Back To Blog

FDA’s First Notice of Noncompliance with ClinicalTrials.gov requirements

On 28 April 2021, the FDA issued its first Notice of Noncompliance to a company failing to submit required summary results information to ClinicalTrials.gov. They determined that the responsible party failed to comply with its legal reporting obligations, even after receiving a Pre-Notice of Noncompliance. They will now have 30 days to submit the required summary results information or face civil monetary penalties for both the violation and the failure to submit the required information.

Read the FDA’s Full Press Announcement


CITI Program’s Clinicaltrials.gov Content

 

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov

This course provides a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial disclosure in ClinicalTrials.gov.
View Course Details

 

Building a ClinicalTrials.gov Compliance Program – Tips for Investigators and Institutions

Reviews reporting regulations, noncompliance, and discusses how to build a successful compliance monitoring program.
View Webinar Details