Published October 4, 2022
In August 2022, the NIH implemented a series of changes to its internal procedures to ensure that scientists are complying with requirements to register studies and submit study results to ClinicalTrials.gov.
The changes to the procedures include:
The NIH policy NOT-OD-16-149 requires that all interventional clinical trials that are funded in part or whole by the NIH and submitted on or after January 18, 2017, must be registered and have results submitted in ClinicalTrials.gov. All interventional trials are included in this policy, even those that are not considered to be Applicable Clinical Trials (ACTs), such as behavioral, surgical, phase 1 drug, and feasibility device studies.
NIH trials are required to be registered in ClinicalTrials.gov no later than 21 calendar days after the enrollment of the first participant. Results information from those trials must be submitted no later than one year after the trial's Primary Completion Date.
The NIH policy refers to how researchers may recover some of the costs incurred due to compliance activities, such as registration on ClinicalTrials.gov. Grantees are permitted to:
The NIH Funding Institute’s or Center’s Office of Grants management sends 30-day notices of noncompliance to the responsible parties who have not submitted the results of their trial to ClinicalTrials.gov after the required reporting timeframe has passed. For responsible parties who fail to comply, the NIH may withhold further funding for the grant and possibly future grants. Additionally, the NIH may take timely reporting of clinical trials into consideration during review of subsequent applications for funding.
Additional validation checks for Research Performance Progress Reports (RPPR) will be assessed to ensure they meet the clinical trial registration and reporting requirements and that remaining funding is not released or subsequent awards are not issued until the noncompliance is resolved. The NIH intends to work closely with institution’s staff to ensure ClinicalTrials.gov compliance.
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