5/18/2021
The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.
The FDA collects information during its inspections related to the Bioresearch Monitoring Program (BIMO), through complaints submitted to the FDA, or through other publicly available means, such as the information submitted to ClinicalTrials.gov, to determine if the sponsor 1) failed to register or submit results to ClinicalTrials.gov, 2) submitted false or misleading information to ClinicalTrails.gov, or 3) failed to submit or submitted false certification to the FDA. Read our blog “Civil Money Penalties & the ClinicalTrials.gov Data Bank Final Guidance” for additional information.
If a sponsor is found to be non-compliant with the requirements, they receive a Pre-Notice of Noncompliance encouraging them to become compliant. For the first time, a sponsor has not voluntarily complied with the Pre-Notice and has received a Notice of Noncompliance for failing to submit the required summary study results. A Notice of Noncompliance may be issued for failing to submit or submitting false information to ClinicalTrials.gov. The sponsor is required to submit the requested information within 30 days of receiving the Notice. A civil money penalty may also be issued in this case.
- The Clinical Pathways Team
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