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Working with Closed, Completed, Withdrawn, and Archived Studies

December 2012

Working with Closed, Completed, Withdrawn, and Archived Studies

Throughout the IRB review process, a study may be closed, completed by the study team, withdrawn by the IRB or the study team, or archived. In some situations, ARROW will automatically close, withdraw, or archive a study if no action is taken by the study team. This document describes when each of these actions occurs, how much time study teams have to take action before a study or application is archived, and when reopening or reactivating a study or application is possible. NOTE: This document includes timeframes only for approved studies and new applications. Please contact the ARROW helpline if you have questions about timeframes for a continuing review, change of protocol, or reportable event.

Closed Studies

When are studies closed? Studies will be automatically closed in in ARROW if a continuing review has not been submitted and IRB approval for the study has expired for 90 days.

When can a closed study be reopened?  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 will then need to be submitted and approved before study activities can resume.

When is a closed study archived? Closed studies are automatically archived by ARROW 12 months after the study has been closed.

Completed Studies

When are studies completed? Studies are listed as completed after a study team has submitted a study completion report to the IRB.

When can a completed study be reopened? 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, the study team may need to submit a continuing review application before study activities can resume.

When are completed studies archived? Completed studies are archived 18 months after a study completion report is submitted to the IRB.

Applications Withdrawn by the Study team

When are applications listed as withdrawn? Applications will be listed as withdrawn if the study team has withdrawn the application from the IRB review process. Applications can be withdrawn by study team at various points in the review process, including before an application is submitted to the IRB, during pre-review, or during the modification or deferral review process. Applications cannot be withdrawn after a study is approved.

When can an application withdrawn by the study team be reactivated? 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.

When are applications withdrawn by the study team archived? 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.

Applications Withdrawn by the IRB

When are application listed as IRB withdrawn?Applications will be listed as IRB withdrawn if ARROW has automatically withdrawn the application from the IRB review process. Applications will be withdrawn by ARROW if a study team does not respond to pre-review issues or IRB modification or deferral requests within 90 days.

When can applications withdrawn by the IRB be reactivated? 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 by the IRB. Study teams can only submit one (1) request to reactivate an application withdrawn by the IRB. If an application has been withdrawn by the IRB, is reactivated and again withdrawn by the IRB, the study team will need to submit a new application if it wishes to reactivate the application.

When are applications withdrawn by the IRB archived? 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 Studies

As noted above, studies or applications may be archived 12 or 18 months after they have been closed, completed, or withdrawn. After a study or application has been archived, it cannot be reopened or copied. Neither the study team nor the IRB can take any further action for a study or application after it has been archived.

Tips

  • Keep track of IRB submissions: ARROW will send email notifications to study teams reminding them of closure, withdrawal, and archiving deadlines. These emails are sent as a courtesy to study teams, who are responsible for keeping track of the status of their IRB studies and applications in progress.
  • Be prepared to respond to pre-review issues: To avoid having an application withdrawn by the IRB, study teams should not submit IRB applications unless personnel are available and able to respond to pre-review comments or modifications requests from the IRB.



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:2016-12-19 10:33 CDT
Sites:Health Sciences IRBs
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