The IB is provided by the sponsor and updated at least annually. It supports the risk/benefit analysis the IRB and investigator must perform, and is referenced when assessing whether an adverse event is expected.
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Glossary Term
Investigator Brochure (IB)
Clinical Operations
Also known as: IB, investigator's brochure
A compilation of clinical and non-clinical data on the investigational product that informs investigators of expected safety and efficacy.
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