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What study materials must the IRB review?

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About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.

The IRB is expected to review all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The protocol, the consent document and, for studies conducted under the Investigational New Drug (IND) regulations, the investigator's brochure are examples of documents that the IRB should review. The IRB should also review the methods and material that investigators propose to use to recruit subjects.

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