Study Closeout Report

Closing Your Study

You must submit a Study Closeout Report for ALL types of studies. The report updates the IRB on the conduct and outcomes of the study, including any risks or problems that may have arisen since the last IRB review and may need to be disclosed to the study participants or others.

Do NOT close out a study if any of the following conditions apply. These studies must remain active with the IRB.

  • Any of the following activities are ongoing at UCSF or UCSF-affiliated institutions OR UCSF is the IRB of Record and any of the following activities are ongoing at sites relying on UCSF:
    • Recruitment/Enrollment
    • Study Procedures
    • Participant follow-up, which includes any contact with participants about the study/Review of medical records for research purposes (including research safety monitoring)
    • Data analysis or manuscript preparation
  • Biological specimens containing individually identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research continues. If specimens were transferred to a separate repository that has ongoing IRB approval, then the study may be closed.
  • You have not received permission from the study sponsor to close the study with the IRB/The study sponsor intends to issue a final report that is not yet ready for submission to the IRB

Submitting a Study Closeout Report

In iRIS, go to My Studies under IRB Study Assistant. Open your study.

Click on the Study Closeout Report link. Click on the Add New Form button and complete the form.

PI must sign off and submit the form.

Once a study is closed, the IRB will not accept any additional submissions for the study.

 

Last updated: May 5, 2022