Institutional Review Board

PURPOSE

The completion or termination of a study is a change in activity and must be reported to the IRB. This SOP outlines the University of Utah IRB policy of reporting the termination or completion of studies.

SCOPE

This SOP applies to IRB approved and exempt research projects at the University of Utah.

POLICY

Investigators submit final project reports to notify the University of Utah IRB of the project’s completion or termination, including exempt studies. The report provides the IRB with the project’s final status allowing the study to be closed. If the Investigator does not apply for continuing review or submit a final project report, the IRB will administratively close the study. Once the IRB acknowledges the final project report, the study file is closed. Study files are retained as described in IRB SOP 308: IRB Records and Retention.

Final project report criteria are posted on the IRB website. Investigators may not submit a final project report in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA) if they are unable to verify such criteria are met.

PROCEDURES

1. Submission of Final Project Reports
   • Final project reports should be submitted within 30 days after completion or termination of the study.
   • The following documentation is required for IRB Review:
     • Final project report application (initiated through a continuing review application in ERICA).
     • Preliminary or final results, if available.
     • Sponsor documentation of study completion or termination, if it exists.

2. IRB Review of Final Project Reports
   • A designated member of the IRB staff reviews all final project reports and, if needed, requests further information from the investigator to clarify any questions that may arise.
   • Once the IRB has determined that sufficient information is provided, the investigator will receive acknowledgement of the final project report and closure of the study.

3. IRB Administrative Closure
   • If a study is expired and an application for continuing review or a final project report has not been submitted, the study will be administratively closed by the IRB. See SOP 307: Expiration of Approval for a description of procedures regarding expired studies.