When an NJH-IRB approved study is completed or terminated, 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 an experienced IRB member. When the NJH IRB approves the study closure, a study completion acknowledgment is forwarded to the Principal Investigator. The completion acknowledgment is part of the regulatory file for the study.
Completion reports should be submitted within 30 days after completion or termination of the study.
Determining When a Study Can Be Closed
Non-industry sponsored (NIH, private agency, investigator initiated, etc.) studies: These studies can be closed when identifiable follow-up data is no longer being collected and data analysis is completed. Typically, if all data analysis is completed and only writing and publication activities are ongoing, 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. This could occur at the end of the study at NJH or at any time the study sponsor requests that the study be closed.
Completion Report Form (updated 08 Aug 2011)