Terminated Studies, Completion Dates, and Results Reporting Avoiding "Late Results"Jun 25, 2021
What if you have a study that is suspended for a long period of time, and a decision is later made to terminate it?
What if you are required to report results, but the decision to terminate comes too long after the last study visit for Primary outcome measure data collection for you to report results on time?
It happens! Here's what to do:
1) In the Study Status section, 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 (for example, last participant’s last visit).
3) Enter the final number of participants enrolled in the Study Design section.
If you are not required to submit results (i.e. study is observational, or is a non-ACT and results are not required by the funder), click the "Complete" button to queue the record for release. You're all done.
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 4.
4) Go back to the Record Summary page, scroll down to the Results section, and click the "Delay Results" link.
5) 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.
6) 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.
For help submitting results, visit our ClinicalTrials.gov Support Webpage, or contact ClinicalResearchSupportCenter@UCDenver.edu