Meg Bouvier Medical Writing is becoming Bouvier Grant Group on March 31st! Read all about our exciting news here. Good Cause Extension for publishing required data

By Meg Bouvier

I stay current on NIH happenings and I’d be delighted to keep you informed.

Researchers with studies whose results must be published to can request a Good Cause Extension (GCE) to extend the deadline for submitting the data. GCE requests must be submitted through the 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.

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