Completing a study closure report involves a few different steps. This process is the same for all application types for both HS IRBs. For information on when a study can be closed, please see Protocol Closure Guidance and Study Closure.
Log into ARROW, and select the study you wish to close.
Locate the study you wish to close by searching for the application title, PI, or ID under the "My Research" Approved tab in your personal workspace. Click on the title to enter the study workspace.
Click "Submit Study Closure Report."
This activity will be available on the left-hand side of the screen, under "Activities."
Complete the closure report.
A pop-up window will appear with five questions for the study team to answer. Click "OK" at the bottom of the form to submit the closure report to the IRB Office.
Respond to IRB comments or questions, if applicable.
The study closure report will either be confirmed or denied by HS-IRBs staff.
If additional information is necessary, the study closure report will be denied and the study team will be notified.
IRB staff may request clarification on enrollment numbers, request changes to study completion date, or verify that a study may be closed. These questions can only be addressed with a new study completion report.
Follow the steps above to create a new study completion report and address the reviewer's questions in the "Additional Comments if applicable" section of the report.
Retain study records.
If the study completion report is confirmed, the study team will receive an automatic notification and study's status will change to "Study Completed" in ARROW. These can serve as documentation of study closure.
The HS IRBs Office does not issue letters for study closure reports.