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How to Close Studies

Procedures to close a study with the IRB

How do I close a study?

  • Step 1: Log in to ARROW.
  • Step 2: Locate the study you wish to close by searching for the IRB protocol number under the Approved tab in your personal workspace.
  • ApprovalState.JPG

  • Step 3: Click on the study name to enter the study’s workspace.
  • Step 4: Under "My Activities" on the left side, click on "Submit Study Completion Report."
  • StudyClosure.JPG

  • Step 5: A pop-up window will appear. Fill out the form.
  • Step 6: Click "OK" at bottom of form to submit both the ARROW completion and Protocol Closure Report.

What happens after a study completion report is submitted?

The study completion report is either confirmed or denied by the HS-IRBs staff.

  • If the study completion report is confirmed, the study will be closed with the IRB and the study’s state will change to Closed in the study workspace.
  • If the study completion report is denied, the study team will be notified and may need to respond to IRB comments or questions before the IRB can close the study.

How do I respond to IRB comments or questions in a study completion report?

IRB staff may request clarification on enrollment numbers, request changes to study completion date, or verify that a study may be closed. To address these questions, first follow the steps listed above to create a new study completion report.

At the bottom of the study completion report, there is a section labeled “Additional Comments if applicable.” Address the reviewer’s questions here.

CommentsSection.jpg

Tips

For more information on when a study can be closed, please see the Protocol Closure Guidance and the HRPP Policy.



Keywords:closure, completed, close, completion, closing, study completion, completion report   Doc ID:17432
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-24 18:00 CSTUpdated:2017-03-01 15:14 CST
Sites:Health Sciences IRBs
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