Update and reminders for clinical trial registration and results reporting
Last week, the NIH implemented new system validations for Research Performance Progress Reports (RPPR) for clinical trial registration and results reporting. RPPRs that have associated clinical trials that are non-compliant with these requirements will receive errors preventing submission of the RPPR. See NOT-OD-22-008 for more details.
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 “FDAAA 801 Violations” field, even though results were posted a day after the Notice was issued.
The requirements for registration and results reporting are as follows:
- Applicable studies 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 applicable studies must be submitted to ClinicalTrials.gov no later than one year after primary completion date (with limited exceptions) for the primary outcome measure, 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 University’s system administrators at [email protected].