CT.gov Good Cause Extension for publishing required data

By Bouvier Grant Group

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Researchers with studies whose results must be published to ClinicalTrials.gov can request a Good Cause Extension (GCE) to extend the deadline for submitting the data. GCE requests must be submitted through the ClinicalTrials.gov Protocol Registration and Results System (PRS) at any time prior to the date of the submission deadline on which the clinical trials results information would be due. Requests submitted on or after the required submission deadline will be rejected. 

The GCE request must include: (1) a complete description of the reason(s) why clinical trial results information cannot be provided according to the deadline, with sufficient detail to justify good cause for the extension and to allow for the evaluation of the request; and (2) an estimated date on which the clinical trial results information will be submitted. Sufficient detail should be provided, including the steps that will be taken to meet the estimated submission date, a description of mitigating steps to avoid future delay, and any other information needed to address the criteria in Section III of this document. 

More than one GCE can be requested for the same study after a previous GCE was granted, following the same rule regarding the timing aforementioned. NIH will provide its response via PRS. NIH can also approve the request, but identify a deadline different than the applicant requested. The applicant may appeal an NIH deadline that is earlier than the initial request.

The general criteria, formatting, and other considerations of a GCE can be found at the link above.

Author:
Dr. Meg Bouvier

Margaret Bouvier received her PhD in 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for long-standing NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. Since 2007, Meg has specialized in editing and advising on NIH submissions, and began offering virtual courses in 2015. She's recently worked with more than 40% of the nation's highest-performing hospitals*, four of the top 10 cancer hospitals, three of the top five medical schools for research, and 14 NCI-designated cancer centers. Her experience at NIH as both a bench scientist and staff writer greatly informs her approach to NIH grantwriting. She has helped clients land over half a billion in federal funding. Bouvier Grant Group is a woman-owned small business.

*Our clients include 9 of the top 22 hospitals as recognized by the 2023/24 US News & World Report honor roll

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