Study Closeout Report

Closing Your Study

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

Do NOT close out a study if any of the following conditions apply.

The study must remain active with the IRB if any of the following activities are still ongoing at UCSF or UCSF-affiliated institutions OR at sites relying on UCSF as the IRB of Record:

  • Recruitment or enrollment of participants
  • Study procedures are still being conducted
  • Participant follow-up is ongoing, including:
    • Any contact with participants about the study
    • Review of medical records for research purposes (including research safety monitoring)
  • Data analysis or manuscript preparation involving identifiable study data
  • Biological specimens containing individually identifiable information are:
    • Being maintained in a repository approved as part of this study
    • Still undergoing analysis or research as part of this study
    • (Note: If specimens were transferred to a separate repository with ongoing IRB approval, the study may be closed.)
  • The study sponsor has not granted permission 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 complete the Relying Site Closeout Form and return it to the UCSF study team.
  2. Ensure the form is fully and accurately completed.
  3. Submit a modification request to close out the site 
  • Attach the closeout report.
  • Remove the site from the application.
  • In the modification description, request that all documents related to the site be voided.
  • If the site appears on documents that will continue to be used, revise those documents 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: March 4, 2025