Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?

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For studies conducted under an investigational new drug application, an investigator's brochure is usually required by FDA. Even though 21 CFR part 56 does not mention the investigator's brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB. The regulations do outline the criteria for IRB approval of research, requiring risks to subjects being minimized and assuring that the risks to subjects are reasonable in relation to the anticipated benefits. The risks cannot be adequately evaluated without review of the results of previous animal and human studies, which are summarized in the investigator's brochure.

There is no specific regulatory requirement that the Investigator's Brochure be submitted to the IRB. There are regulatory requirements for submission of information which normally is included in the Investigator's Brochure. It is common that the Investigator's Brochure is submitted to the IRB, and the IRB may establish written procedures which require its submission. Investigator's Brochures may be part of the investigational plan that the IRB reviews when reviewing medical device studies.

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. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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