Closing Your Study

🔒Closing Your Study

To close your study, submit a Continuing Review Form in Research Gateway IRB (ReGI). This form is used to complete study closure and 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 (pSites): : 

  • 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

📁Closing Your Study in Research Gateway IRB (ReGI)

  1. Open your study in ReGI.
  2. Click the Create Modification/CR button.
  3. In the “Type of Submission” question, select Continuing Review.
  4. Continue through the form, answering every question relevant to your study, not just those with red asterisks. Use the Help bubbles for guidance.
  5. In the “Study Milestones” question, you must select the FIRST FOUR boxes to close the study. You will then be asked to confirm that you wish to close the study. Note: You cannot close the study if you have any active submissions still under review by the IRB.
  6. Attest that the study can be closed and answer the rest of the questions in the form.
  7. The PI or PI Proxy must submit the form. 

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

Closing Exempt Studies

  • Non-migrated exempt studies: If you need to close an exempt study that was originally certified as exempt in iRIS and not migrated to ReGI, you do not need to notify the IRB or submit a request to close the study in ReGI.
  • Exempt studies created in or migrated to ReGI: Close the study in ReGI (as described above) when the research is complete.

🏢Submitting a Study Closeout Report for a Relying Participating Site (pSite)

Relying/pSite Study Team:
  • Have the pSite complete the HRP-812: Site Continuing Review Form and return it to the UCSF study team. This form is used for both continuing review and as a final report to close a site. 
UCSF Study Team: 

  • If the study is due for Continuing Review: Attach this form in the ATTACH SUPPORTING DOCUMENTS section of the Continuing Review Form. 

  • If the study is not due for Continuing Review: If you wish to close the site and the study does not undergo continuing review or is not due for continuing review, you can submit this form via a modification

📕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.

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