Results information reporting is due within one year of the primary completion date (PCD).
Good Cause Extension Process Summary
There may be times when it is appropriate to request to extend the submission deadline for clinical trials results information reporting to clinicaltrials.gov.
Situations that may be considered “Good Cause” for granting an extension request include:
- Need to preserve scientific integrity of study for which data collection is ongoing (i.e., situation that would impair or otherwise bias the ongoing collection, analysis, and/or interpretation of data for secondary outcome(s).
- Emergencies that would prevent timely submission of clinical trial results information (i.e., data collection sites were affected by natural disasters)
- Reporting delays due to unexpected personal emergency circumstances (i.e., death or extended personal illness)
Examples of situations that would not be considered “Good Cause” for granting an extension request include:
- Certification of delay should have been submitted rather than a good cause extension request
- Awaiting journal publication: A study must report clinical trial results information even if the data have not yet been published
- Pending FDA or other regulatory/health agency review (i.e., A study must report clinical trial results information even if the data are under FDA or other regulatory/health agency review)
- Ongoing data analysis without sufficient explanation (i.e., Analysis that is not yet complete, without further explanation, is not adequate justification for “good cause.”)
- Events that might reasonably have been avoided (i.e., transition planning for key staff members who leave an organization)
Steps to request a Good Cause Extension (GCE) during the clinical trials results information reporting process
- The Responsible Party (RP) will discuss the request for a GCE with Lisa King
- The RP will send Lisa an email and include:
- 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
- an estimated date (month/day/year) on which the clinical trial results information will be submitted. Typically, 30 days after original results submission deadline.
- Lisa will then submit the request through the ClinicalTrials.gov Protocol Registration and Results System (PRS) PRIOR to the date clinical trials results information is due (i.e., standard results submission deadline)
- The RP will be notified via email if GCE is approved or denied.
- There is an appeal process if denied.
Special Considerations for NIH Awardees (NIH-funded and supported clinical trials), if applicable
- Any good cause extension request could impact other aspect of the contract or grant award.
- submission of a “Request for an Extension for Good Cause” does not constitute a prior approval request submission (e.g., No Cost Extension and Carryover) or a request for contract modification (e.g., contract extension or change to deliverable due date).
Resources
Results Information Reporting to ClinicalTrials.gov
Requirements for Registering and Reporting NIH-Funded Trials in ClinicalTrials.gov
NIH Policy Manual: 3007 – Clinical Trial Registration and Results Information Reporting
Guide to FDAAA Reporting Research Results
Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria
Deadline for updating clinical trial registration/other information
ClinicalTrials.gov Resources