Closing a Study

Do I need to close my study with the IRB?

Every study, whether approved by the IRB under the pre-2018 or 2018 rules, should be closed with the IRB once all four of the following criteria are met:

✔  The study is permanently closed to enrollment.
✔  All subjects have completed all study-related interventions.
✔  Collection of private identifiable information is complete.
✔  Analysis of private identifiable information is complete.

It is important to know that closing the study with the IRB is permanent and the study cannot be reopened once it is closed.

I am ready to close my study - how do I submit this to the IRB

In the eIRB system, study closures are submitted via the continuing review function.

To create a study closure, select "Create Modification/ CR button under "My Current Actions" in the left panel. Review and follow all steps outlined in the Closing a Study section of eCompliance/eIRB Guidance.

Be sure to follow all study closure requirements outlined by the study sponsor and within the KUMC Research Record Management, Disposition and Retention Policy (login required).