February 8, 2023
NOT-OD-16-149 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
Office of The Director, National Institutes of Health (OD)
The purpose of this Notice is to inform the research community that NIH has issued the Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria outlining the process and criteria for requesting a good cause extension of the submission deadline for clinical trial results information (Good Cause Extension request) under 42 CFR 11.44(e) of the Final Rule for Clinical Trials Registration and Results Information, (Final Rule), section 402(j)(3)(E)(vi) of the Public Health Service (PHS) Act, and the complementary NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) (complementary policy).
The U.S. Department of Health and Human Services issued the Final Rule in 2016, effective on January 18, 2017, that expands and clarifies the regulatory requirements for submitting registration and results information for certain clinical trials to ClinicalTrials.gov. The NIH issued a complementary policy establishing the expectation to register and submit results information to ClinicalTrials.gov for all NIH-funded clinical trials, including those not subject to the Final Rule.
The Final Rule states that in general and with exceptions, the standard submission deadline for clinical trials results information is no later than 1 year after the primary completion date. However, in some instances, a good cause extension request may be sought for the following categories of trials:
The Good Cause Extension Request Process and Criteria will be implemented beginning February 15, 2023. The document outlines the information to be included in each request, and the criteria NIH will use to evaluate and make a determination as to whether to grant or deny an extension. It also provides a non-exhaustive list of situations the agency would generally consider to constitute good cause and not good cause for granting or denying an extension request. The document also has information on how to appeal a denied good cause extension request under 42 CFR 11.44(e)(3).
An extension request must be submitted electronically via PRS prior to the date (i.e., the day before) that results information would otherwise be due and must include a description of the reason(s) that the responsible party believes constitute good cause to justify an extension and an estimated date on which the results information will be submitted. The extension request will be reviewed, and the responsible party will be notified electronically as to whether the extension request has been granted or denied. Responsible parties may appeal denied requests.
Failure to comply with submission of required results information may provide a basis for enforcement actions.
For more information, refer to frequently asked questions at https://clinicaltrials.gov/ct2/manage-recs/faq
For inquiries regarding submission of a Good Cause Extension request or general ClinicalTrials.gov support, please contact:
National Library of Medicine (NLM)
For NIH grants policy or compliance questions, please contact:
NIH Division of Grants Compliance and Oversight