If you have a study registered in ClinicalTrials.gov that meets the Applicable Clinical Trial (ACT) definition and/or an NIH-funded “Clinical Trial,” please be aware that results reporting is required by federal law.
Did You Know?
The due date for results reporting is based on collection of the last participant’s last (primary) outcome-related data. Results must be reported by no later than 1 year of the collection of these data. Thus, if enrollment efforts continue well beyond collection of the last primary outcome data without realizing further enrollment, the allowable reporting period can be compromised or exceeded leaving you with limited time to complete results reporting in the former or causing results reporting to be overdue before the process starts in the latter. While this is more often seen with trials having prolonged enrollment due to demanding entry criteria or investigational product availability issues, it is important to be mindful of this for all trials.
Don’t be caught off guard by CT.gov’s inflexible reporting timeline—be prepared to report results based on collection of the last primary outcome data.
As a reminder, the FDA can impose daily civil $$ penalties for non-compliant studies of $12,316 until resolved. If incurred, these fees will be billed to your department. For non-compliant studies receiving NIH funding, award monies can be retracted, and future funding can be jeopardized for the PI and the University as well.
I am available if you have questions. Thank you for helping UNC remain compliant!
Monica Coudurier
Clinical Trials Project Manager
UNC-CH Office of Clinical Trials
720 Martin Luther King, Jr. Blvd, CB 1651
Chapel Hill, NC 27599-1651
(919) 843-2333 Phone
https://research.unc.edu/clinical-trials/clinical-trials-gov/overview-policy/