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.
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.
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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.
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