Shaping Better Investigator Brochures

The Investigator's Brochure is a crucial multidisciplinary document in the drug development and regulatory submission process. We provide key learnings to ensure you delivery of a well-constructed, fully compliant document.

Learn about:

Structure and required content

Core writer skills

A brochure’s multifunctional nature

Managing document development

Brochure evolution

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Frequently Asked Questions about the Insider’s Insight: Investigator's Brochure

To help you get the most out of our resource library, we have compiled answers to the most common questions regarding the development, application, and distribution of our specialist guides.

At Niche Science & Technology, we believe that sharing expertise is the first step toward industry-wide excellence.

What is the main purpose of an Investigator’s Brochure (IB)?

The IB summarizes all relevant clinical and non‑clinical information about an Investigational Medicinal Product (IMP). Its purpose is to help investigators understand the rationale for the study, guidance on dosing, safety monitoring, and the potential risks and benefits to subjects. It must remain concise, balanced, and non‑promotional

How often should an Investigator’s Brochure be updated?

ICH E6 guidelines recommend that the IB be reviewed at least annually and also revised whenever significant new data affecting the understanding of the IMP’s safety or efficacy becomes available. Regulatory authorities check that updates are accurate, complete, and unbiased

What sections must an Investigator’s Brochure include?

According to ICH E6 (Section 7), an IB must contain:
- Summary
- Introduction
- Physical, chemical, and pharmaceutical properties
- Non‑clinical studies
- Effects in humans
- Summary of data and guidance for the investigator

These ensure that investigators have a structured source of essential information for trial conduct and safety management

What is Reference Safety Information (RSI) and why is it required?

RSI is a designated section within the IB that lists expected serious adverse reactions (SARs) based on prior evidence of a causal relationship with the IMP. It is critical for determining whether a serious adverse reaction in a clinical trial is expected or unexpected and therefore whether it requires expedited reporting as a Suspected Unexpected Serious Adverse Reaction (SUSAR)

Why must the IB remain non‑promotional?

Although IBs are sometimes viewed by start‑ups or biotech companies as showcase documents, regulatory guidance makes clear that the IB must not be promotional and must not overstate potential efficacy. Its primary role is to support investigator understanding and ensure subject safety, not to market the IMP

Shaping Better Investigator Brochures

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Frequently Asked Questions about the Insider’s Insight: Investigator's Brochure

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