Investigator Brochure (IB)
The compilation of clinical and nonclinical data on an investigational product relevant to its study in humans.
What it means
The Investigator Brochure is a living document that summarizes chemistry, pharmacology, toxicology, and prior clinical experience for an investigational product. LATAM regulators expect IB updates to be translated and refiled whenever the reference safety information changes, because the ICF's risk section derives from it.
Why it matters for LATAM submissions
An IB update that is not mirrored in the Spanish or Portuguese ICF risk list is a common cause of ethics committee holds. Version control across languages is the discipline that avoids it.
Relevant regulators
Related terms
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