Study Completion & Closure

The completion or termination of a study is a change in activity and must be reported to the IRB. Although subjects will no longer be “at risk” under the study, a final report/notice to the IRB allows it to close its files.

Determining When a Project Can Be Closed

HHS-supported protocols: When individually identifiable follow-up data are no longer being collected on subjects enrolled in an HHS-supported protocol and analysis that could indicate new information is complete, the study may be closed.

Multi-site industry studies may be closed when the Investigator submits his or her final report.

Completion reports should be submitted within 30 days after completion or termination of the study. Completion reports will be submitted on a Completion Report Form. Completion reports may be submitted by the Investigator's designee at the investigative site. The IRB Regulatory Affairs Monitor will review all reports of study completion with the IRB Chair and, if needed, request further information from the Investigator to clarify any questions that may arise.

A listing of closed studies will be presented to the IRB at the next scheduled meeting.

Completion Report Instructions

Completion Report Form

Internal Adverse Events Addendum Table