An Introduction to the Investigator's Brochure (IB) [Video]

The investigator’s brochure (IB) is the controlled reference document that brings together the key clinical and non-clinical evidence on an investigational product. In this explainer, we break down what an investigator’s brochure is for, why it matters beyond the protocol, and what teams need to get right to keep it useful, current, and reliable in practice.

What This Video Covers
• What an investigator’s brochure means in clinical trials
• Why the IB matters for dosing, monitoring, and safety oversight
• What the core sections of a usable IB typically include
• How Reference Safety Information fits into the IB
• Common pitfalls, including poor version control, weak distribution, and misalignment with the protocol

A strong investigator’s brochure should do more than collect product data. It should help investigators interpret risk, apply the latest evidence consistently across sites, and support safer day-to-day trial conduct. That depends on clear structure, objective language, timely updates, and strong document governance.

At Quanticate, our clinical and regulatory teams support sponsors with practical, rigorous support across clinical trials and regulated development. Request a consultation today.