Working with Closed, Completed, Withdrawn, and Archived Studies


State What It Means Actions Archive Deadline
Closed Study has been closed automatically by ARROW if a continuing review has not been submitted and IRB approval for the study has expired for 90 days or, for select studies, if a study renewal request has not been submitted. Study teams can submit a request to reopen a closed study up to 12 months after the study has been closed. A continuing review application may then need to be submitted and approved before study activities can resume. Closed studies are automatically archived by ARROW 12 months after the study has been closed.
Study Completed The study team has submitted a study closure report to the IRB and the IRB has approved the report. Study teams can submit a request to reopen a completed study up to 18 months after the study completion report has been submitted to the IRB. Depending on when the request to reopen is submitted and the continuing review status of the study, a continuing review application may need to be submitted before study activities can resume. Completed studies are archived 18 months after a study completion report is submitted to the IRB.
Withdrawn The study team has withdrawn the application from the IRB review process. Applications cannot be withdrawn after a study is approved. Study teams can reactivate an application they have withdrawn by sending the application back to pre-submission up to 12 months after the application has been withdrawn. Applications withdrawn by the study team are archived 12 months after they have been withdrawn unless the study team sends the submission back to pre-submission.
IRB Withdrawn ARROW has automatically withdrawn the application from the IRB review process because a study team has not responded to pre-review issues or IRB modification or deferral requests within 90 days. Study teams can reactivate an application withdrawn by the IRB by submitting a request to reactivate up to 12 months after the application has been withdrawn . Study teams can only submit one (1) request to reactivate an application. If an application has been withdrawn by the IRB, is reactivated and again withdrawn by the IRB, the study team will typically need to submit a new application if it wishes to reactivate the application. Applications withdrawn by the IRB are archived 12 months after they have been withdrawn unless a request to reactivate is submitted by the study team.
Archived As noted above, studies or applications may be archived 12 or 18 months after they have been closed, completed, or withdrawn. Neither the study team nor the IRB can take any further action for a study or application after it has been archived. N/A



Keywords:closed, completed, withdrawn, archive, archived, re-open, reopen   Doc ID:27634
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-12-11 10:33 CDTUpdated:2017-12-13 16:05 CDT
Sites:Health Sciences IRBs
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