OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

Lexology August 23, 2022
Hogan Lovells

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to ClinicalTrials.gov in 2019 or 2020, a majority did not have their results timely submitted. As a result, OIG has recommended that NIH take additional enforcement actions against responsible parties that fail to meet their clinical trial reporting requirements, and NIH has responded that it is enhancing its abilities to track ClinicalTrials.gov non-compliance for its studies.

Federal law requires responsible parties (typically clinical trial sponsors) to submit results for their studies registered on ClinicalTrials.gov, generally no later than one year after the study’s completion date. However, according...

Today's Sponsors

Today's Sponsor