Effective October 1, 2021, the NIH issued an update in the Human Subjects System (HSS) regarding enhancements to clinical research trial registrations and results reporting as it relates to compliance with Clinicaltrials.gov regulations. Detailed below are some key points from the announcement.
- A warning message will be displayed if enrollment of the first participant was > 21 days and ≤ to 30 days ago and no NCT number was provided.
- Updated warning message will display an error if the actual primary completion date was > 12 months ago and the results have not been reported to Clinicaltrials.gov.
- A new error message will be displayed if enrollment of the first participant was enrolled > 30 days ago and no NCT number has been provided.
To find out more please visit https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-008.html
As a reminder, failure to register or report results data for an Applicable Clinical Trial (ACT) as per FDAAA 801 and the Final Rule or the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information can result in immediate suspension or termination of funding, monetary civil penalties of up to $10,000 per day of non-compliance, criminal or civil prosecution, and/or a permanent notice of non-compliance publicly posted on the ClinicalTrials.gov record for a study.
Of note, the FDA issued its first Notice of Noncompliance to an individual investigator conducting a trial sponsored by an academic institution. The Principal Investigator (PI) failed to submit required results data to ClinicalTrials.gov. As a result of this noncompliance, the ClinicalTrials.gov record for the study will be permanently marked with and searchable by the In addition, the FDA has issued its first Notice of Noncompliance to an individual investigator conducting a trial sponsored by an academic institution. The Principal Investigator (PI) failed to submit required results data to ClinicalTrials.gov.
Detailed below are the requirements for an applicable clinical trial for registration and results reporting:
- Applicable clinical trials must be registered no later than 21 days after enrollment of the 1st participant (i.e., date of when the 1st participant signs a study consent form).
- Results information for an applicable clinical trial must be submitted to ClinicalTrials.gov no later than one year after primary completion date for primary outcome measures, and one year after the study completion date for all other outcome measures, including safety data.
If you require assistance with ClinicalTrials.gov registration or results reporting, please contact the UF ClincialTrials.gov program: UFCTemail@example.com.