Must an investigators brochure be included in the documentation when an IRB reviews an investigational drug study?
For studies conducted under an investigational new drug application, an investigator’s brochure is usually required by FDA [21 CFR 312.23(a)(5) and 312.55]. 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. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure 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
Related Questions
- The studys sponsor has sent me an Investigators Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
- Must an investigators brochure be included in the documentation when an IRB reviews an investigational drug study?
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