Terminated Studies and Results Reporting Deadlines: Avoiding "Late Results"
Jul 7, 2022
If required, results must be submitted to ClinicalTrials.gov within 12 months of the Primary Completion Date, even if the study was terminated.
The Primary Completion Date is the last study visit where a participant was examined or received an intervention for the purposes of data collection for the Primary Outcome Measure(s). This definition, which usually equates to the last participant's last study visit, also applies to terminated studies.
However, sometimes studies are suspended or have difficulty enrolling for long periods of time, and the decision to terminate is made after it would be too late to report results before the 12 month deadline. Here's what you'll need to know in these cases:
For Applicable Clinical Trials (ACTs, federally mandated to submit results), requests to delay results reporting for good cause can be submitted to ClinicalTrials.gov (for non ACTs required to submit results by the funder, you'll need to work directly with the funder on a reporting timeline).
However, the decision to terminate must be made and the request to delay results MUST be submitted to ClinicalTrials.gov before the due date for results (i.e., before 12 months after the last participant's last study visit). Therefore, it is very important for P.I.s of ACTs that are low-enrolling or suspended to keep a close eye on the length of time since their last study visit, if termination is a possibility.
If you need to request delayed results reporting for a terminated study, here is what to do:
1)In the Study Status module in the record, change the "Overall Recruitment Status" to "Terminated" and give a reason.
2) Enter the Primary and Study completion dates as usual according to the ClinicalTrials.gov definitions:
Primary Completion Date: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome measure(s).
Study Completion Date: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (usually both are the, last participant’s last visit).
3) Click "Save".
4) Enter the final number of participants enrolled in the Study Design module and change the type to "Actual" (the system may or may not prompt you to do this).
If your study is NOT an Applicable Clinical Trial (ACT), but you are required to submit results because of the funder's policy (e.g., NIH), click the "Complete" button on the record to make it public, and then contact your funder to work with them on a timeline for results submission.
If your study IS an ACT, continue to step 5.
5) Go back to the Record Summary page, scroll down to the Results section, and click the "Delay Results" link.
6) Enter the reason for the delayed results (e.g. that the decision to terminate wasn't made until now), and a requested results submission date. This date should be no more than one year after the decision to terminate the study.
7) Submit the request and click "Complete" on the Record Summary page to queue the record for release.
All delay requests are reviewed by the NIH Director and are accepted if the Director determines that the delay request shows good cause.
