On August 17, 2020, the FDA announced final guidance on the enforcement procedure for ClinicalTrials.gov reporting requirements. Penalties of up to $10,000 per violation plus an additional $10,000 per day until the violation is corrected, have been confirmed by the final guidance. This applies to those who fail to report applicable clinical trials (ACTs) or submit false or misleading information. The guidance also allows for the possibility of civil injunction and/or criminal prosecution. The FDA will also post violator’s notices of noncompliance on its website and the National Institute of Health (NIH) will upload the notices to clinicaltrials.gov. The FDA states they will identify violators using information gathered during the routine inspections conducted by the Bioresearch Monitoring (BIMO) program. Per CenterWatch, The NIH issued new rules on July 30,2020 that mandate clinical trial sponsors submit missing data for studies conducted between 2007 and 2017. Those sponsors who fail to submit the required results information may be subject to monetary penalties as well as the withholding of remaining grant funds.
The full CenterWatch articles may be found here:
The final guidance may be found here: https://www.fda.gov/media/113361/download
A ten-minute podcast that discusses the legal implications for investigators may be found here:
For questions regarding clinicaltrials.gov, please contact:
Jerri Mendivel, Research Compliance Manager
(909) 558-9408 Extension 49408
jmendivel@llu.edu