Completion

The completion or termination of a study is considered a change in study status and therefore must be reported to the IRB.

Determining When a Study Can Be Closed

Non-industry sponsored (NIH, private agency, investigator initiated, etc.) protocols: When identifiable follow-up data are no longer being collected and data analysis is completed, the study may be closed.

Industry protocols: Industry sponsored studies may be closed when the investigator submits his or her final report to the IRB.

Completion reports should be submitted within 30 days after completion or termination of the study. Completion requests must be submitted on a Completion Report Form signed by the Principal Investigator.

Each completion/termination report is reviewed by a primary reviewer and the IRB Chairperson. A completion acknowledgment is issued to the Principal Investigator when the IRB closes the study.

Completion Report Form (updated 29 Jun 2009)


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