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Are you requesting to close a IRB, sIRB, or hSCRO protocol?

• An IRB protocol may be closed once subject accrual has ended, research interventions and data collection are complete, and analyses of subject identifiable data have concluded.

• The official retention period for UCI's IRB records begins on the date a closing report is submitted by the Lead Researcher (LR).

For more information, visit:

• Protocol Closure
• Lead Researcher's IRB Recordkeeping Responsibilities

Provide a brief summary of any results (preliminary or final) obtained in the study:

Closing criteria:

• All subject specimens, records, data have been obtained (i.e., no further collection is required).
• No further contact with subjects is necessary (i.e., all interactions or interventions are complete).
• Analysis of subject identifiable data, records, and specimens are complete (i.e., use or access to subject identifiable data and review of source documents by study sponsors is no longer necessary).

Please mark the option that represents the closing status of subject enrollments:

Have there been any problems that required prompt reporting to the UCI IRB?

Have there been any problems that were reported to the IRB of Record, but were not reported to the UCI IRB?

REQUIRED! Promptly submit a Reportable Event along with the closing.

IMPORTANT! Reportable Events must be submitted within 5 business days of the occurrence or within 5 business days from the date in which the Lead Researcher learned of the occurrence.

Please explain why the problem(s) has not been reported to the UCI IRB:

Have there been any complaints from UCI participants or others that required reporting to the UCI IRB?

Please explain the complaints that require reporting:

Provide a brief summary of the project's results (preliminary or final):

Submit any supporting documents for the closure in the Attachments section below.

REQUIRED! Submit a copy of the IRB of Record?s Closing Report acknowledging that UCI, as a Relying site, has been closed. 

Upon submission of this final closing application, I hereby certify my intent to close the study and I affirm that all the information contained herein is true and accurate to the best of my knowledge. If additional significant information about the safety or welfare of study participants should become available after study closure, I will forward it to the IRB promptly for review and inclusion in the protocol record.

Upon submission of this final closing application, I hereby certify my intent to close the study and I affirm that all the information contained herein is true and accurate to the best of my knowledge.