Reporting requirements for studies listed at ClinicalTrials.gov
If you have a study registered at 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.
The due date for results reporting is based on collection of the last participant's last (primary) outcome-related data. Results must be reported no later than 1 year after collection of these data.
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, causing your results reporting to be overdue. The FDA can impose daily civil penalties of $12,316 for non-compliant studies 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.
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 reporting timeline. Be prepared to report results based on collection of the last primary outcome data.