USA – FDA finalizes penalties for trial reporting violations

The US Food and Drug Administration has finalized guidance for civil money penalties it may levy for clinical trial data bank reporting violations.
 
The final document follows a September 2018 draft that addressed the question of how FDA’s Centers should deal with responsible parties who breach federal regulations requiring accurate and complete registration of clinical trials and reporting of results on the www.clinicaltrials.gov website.
 
This final guidance details how centers within FDA plan to identify if responsible parties have failed to submit required clinical trial registration or results to the ClinicalTrials.gov data bank, or if parties have falsified data or filed misleading information, or failed to submit certification to FDA. Generally, evidence kicked up during the FDA’s Bioresearch Monitoring Program (BIMO) will serve as the basis for identifying violators, according to the guidance, though action may also be complaint-driven.