New Resources Available on Submitting Good Cause Extension Requests for Results Reporting to


Do you have questions about when it’s allowable to request an extension of the deadline for submitting clinical trial results information to, how to request an extension, what to include, and how the requests are evaluated? A recently published resource, Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria (announced in NOT-OD-23-080), explains all this and more.

The Final Rule for Clinical Trials Registration and Results Information Submission (“the Final Rule”) states that in general, 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:

  • Applicable clinical trials (ACTs) that are subject to the Final Rule (42 CFR 11.42).
  • Clinical trials subject to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

You can learn more about submitting results and explore new and updated FAQs on the website. Here are just a couple of the new FAQs about the good cause extension request process to pique your interest:

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