February 2023: What’s New on ClinicalTrials.gov

On February 08, 2023, the below update was posted on ClinicalTrials.gov, What’s New section:

Good Cause Extension (GCE) Request Process and Criteria.

The Good Cause Extension Request Process and Criteria is a document intended to explain to responsible parties the process of submitting a good cause extension request to extend the deadline for submitting clinical trial results information to ClinicalTrials.gov and the information necessary for the National Institutes of Health (NIH) to evaluate and provide a decision for the GCE requests.

New and Updated FAQs are available to clarify the Good Cause Extension Request Process and Criteria.

• • New FAQs:

• • • How does NIH determine whether to grant or deny a good cause extension request submitted under 42 CFR 11.44(e)?

• • • What is the process to file an appeal after a good cause extension request for delayed submission of results information has been denied or granted with an earlier deadline than requested?

• • Existing FAQs under the Results Information and Submission Deadlines related to GDE Request have been updated

The same update was posted on Clinicaltrials.gov PRS Test, which will go live on February 15, 2023:

The ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies document has been updated to reflect edits made to the following data fields in the Delayed Results section.

• • Appeal Justification
  • Requested Submission Date (Day now required)
  • Explanation