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

Submitting a Study Closeout Report

1. Open your study in iRIS

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

2. Add a new Study Closeout Report and complete it

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

3. Submit the form to the IRB

PI must sign off and submit the form.

Once a study is closed, the study will not be reactivated.

Submitting a Study Closeout Report for a Relying Site

1. Have the relying site fill out the relying site closeout form and return it to the UCSF study team. 

2. Ensure that the form is filled out well and completely. 

3. Submit a modification to closeout the site.

  • Attach the closeout report.
  • Remove the site from the application, and request in your modification description that all documents related to that site be voided. If the site is listed on other documents that will be continues to be used, please revise them in this submission. 

Clinical reports

There is no requirement to submit final clinical study report(s) to the IRB, no matter the stage of the study. However, the IRB requests that you forward any final clinical reports that you receive to our attention at [email protected] so that we may review any relevant safety data that may inform future study reviews.

Last updated: November 2, 2023