Must I submit an investigator’s brochure to the IRB when the IRB is reviewing an investigational drug study?

Must I submit an investigator’s brochure to the IRB when the IRB is reviewing an investigational drug study?
​Yes. For studies conducted under an IND the FDA requires that an investigator’s brochure be submitted. Although not mentioned specifically in 21 CFR part 56, much of the information contained in the IB is clearly required to be reviewed by the IRB such as assuring the risks to the participants are reasonable in relation to the anticipated benefits which cannot be adequately evaluated without the review of the IRB.