Study Closeout Report

When closing a research study, a Study Close Out Report must be submitted to the IRB. This written report is intended to inform the IRB of the study closeout activities which have been performed as well as report study outcomes, problems or new discoveries that may need to be disclosed. If the study is a sponsored clinical trial, the report will be written by the Sponsor, however if an investigator initiated study or student research project, it must then be written by the Principal Investigator.

The study close out report should state whether or not the primary goals of the study have been met, if there were any Serious Adverse Events (SAEs) or other unexpected issues. The report should also state that all research activities are complete and that it is acceptable to close the study with the IRB. If the study is a blinded drug study, it must be discussed in this report, if and how un-blinding will take place. For further assistance with Study Close Out Reports, please submit a consultation request.

Helpful Links

Research & Innovation SOPs:

• PM 306 – Study Completion (PDF, 184KB)
• PM 306A – End-of-Study Documentation Checklist (PDF, 82KB)

Institutional Review Board SOPs:

• RR 407 – Study Completions (PDF, 250KB)