FDA Issues First Notice of Noncompliance to an Individual Investigator for Failing to Submit Results to ClinicalTrials.govSep 16, 2021
On August 31, 2021, FDA issued a Notice of Noncompliance to an individual investigator for failing to submit required results data to ClinicalTrials.gov. The Notice was issued to surgeon Andrey Petrikovets, who conducted a clinical trial sponsored by University Hospitals Cleveland Medical Center, an academic center affiliated with Case Western Reserve University. Dr. Petrikovets is no longer affiliated with either organization.
The Notice marks several new developments in FDA’s enforcement ramp-up:
- This is the first time the Agency has warned an individual investigator, rather than a drug maker.
- This is the first time FDA has brought enforcement action related to a trial sponsored by an academic institution.
- The Notice describes and refutes two common arguments from the Responsible Party/PI: 1) that the results should not be required to be submitted because they are already available in the published manuscript, and 2) that the investigator is busy and short staffed due to the COVID-19 pandemic and does not have time to comply.
Although the results were submitted to ClinicalTrials.gov one day after the Notice was issued, the ClinicalTrials.gov record for the study will be permanently marked with and searchable by the “FDAAA 801 Violations” field.
In addition to the issuing of a Notice of Noncompliance, which remains permanently public, FDA is authorized to seek civil money penalties of up to $10,000 per day for failure to submit required information to ClinicalTrials.gov.
It is also important to note that, in the case of an IND or an IDE study where results reporting is required, the IND or IDE holder will be considered by FDA to be the Responsible Party for the study. In these cases, FDA may not contact the University, and may send pre-Notices and Notices directly to the IND/IDE holder.
If you have a record that is out of compliance (e.g. for late or missing results information), or if you need to register or update a record on ClinicalTrials.gov, contact email@example.com.
Tags: 42CFR11 clinicaltrials.gov clinicaltrials.gov problems FDAAA801 late results results