Frequently Asked Questions

Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?

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Clinical Trials
Clinical: MedTech
Clinical: Biopharma
IRB: General

IRBs are required to function under written procedures. One of these procedural requirements requires ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should 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 as well as providing information that may be used by the IRB in the evaluation and approval of related studies.