The “Active, Not Recruiting” Study Status
Jul 28, 2022
The “Active, Not Recruiting” status in ClinicalTrials.gov is often misinterpreted. This status should only be used to indicate that “participants are still receiving an intervention or being examined, but new participants are not currently being recruited or enrolled”.
This status should NOT be used to indicate that all participant visits are completed, but that the study is still open to IRB, data analysis is still ongoing, or the manuscript is pending publication.
It is very important that once the study reaches the Study Completion Date (usually the last study visit by any participant), the Record Owner changes the Overall Recruitment Status to “Completed”.
The Study Completion Date is defined as “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), whether the clinical study concluded according to the pre-specified protocol or was terminated”
To update the Study Status:
- Log in to https://register.clinicaltrials.gov/ (Username = your email, organization = UColorado).
- Open the record.
- Open the Protocol section.
- Edit the Study Status module.
Change the Overall Recruitment Status, and if necessary, enter the Primary and Study Completion Dates and the number of participants enrolled (enrollment is under the Study Design section).
primary completion date
study completion date