'Femi Fajimi

Investigator’s Brochure and Updates: A Beginner’s Guide 

By Femi Fajimi | 26 April 2025 

When I first heard “Investigator’s Brochure,” I assumed it was a patient-facing document, perhaps a summary leaflet. However, I soon discovered that the IB is one of the most essential internal documents in a clinical trial. 

The Investigator’s Brochure (IB) is a comprehensive, scientific document that provides clinical investigators and study teams with a summary of the preclinical and clinical data on the Investigational Medicinal Product (IMP). It’s prepared by the sponsor and is updated regularly to reflect emerging safety and efficacy findings. 

What Is the Investigator’s Brochure (IB)? 

According to ICH E6 (R2) Good Clinical Practice, the IB is: 

“A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the product(s) in human subjects.” 

— ICH E6 (R2), section 1.36 

In simpler terms, the document helps investigators understand the rationale, risks, safety profile, and handling requirements of the drug being studied. It’s essential for trials of new or unlicensed medicines, where standard product information (like a Summary of Product Characteristics) isn’t available. 

What Does an IB Typically Include? 

The structure and content of the IB is guided by ICH E6 (R2), section 7, and typically includes the following sections: 

1. General Information 

Drug name, manufacturer, formulation 

2. Nonclinical Studies 

Pharmacology 

Toxicology 

Pharmacokinetics and metabolism 

3. Clinical Studies 

Safety and efficacy findings from prior human trials 

Dose ranges and administration methods 

Adverse drug reactions and precautions 

4. Summary of Data and Guidance for Investigators 

Risks and benefits 

Contraindications 

Monitoring guidelines 

Investigator responsibilities 

5. Reference Safety Information (RSI) 

This section is crucial for pharmacovigilance. It defines what adverse reactions are

expected and forms the basis for SAE reporting. 

Disclaimer: 

This sample Investigator’s Brochure was created for educational purposes only. MolendiiP Pharma Ltd, Dermalexiin, and the study described are fictional. 

Updates to the Investigator’s Brochure 

The IB must be kept up to date throughout the clinical trial. Major updates are typically issued at least annually or more frequently if significant safety information emerges. 

This process is governed by both ICH E6 and local regulatory requirements (e.g. MHRA in the UK). 

What Triggers an IB Update? 

• New nonclinical or clinical safety findings 

• Emerging data from ongoing studies 

• Identification of a new risk or adverse reaction 

• Changes to the Reference Safety Information (RSI) 

What Must Be Documented? 

When an IB is updated, the sponsor should: 

• Highlight changes from the previous version. 

• Update the version number and date. 

• Re-submit the document to relevant ethics committees and regulatory authorities. 

• Ensure that all investigators receive and acknowledge the updated version. 

What This Means for Medical Writers 

As a beginner regulatory writer, I’ve learned that contributing to the IB involves: 

• Reviewing large volumes of preclinical and clinical data 

• Writing or editing clear summaries of scientific findings 

• Maintaining consistency with other core documents (e.g. protocol, Clinical Study Report) 

• Applying guidance from ICH, EMA/FDA, and the ABPI Code (Clause 7.2) regarding non-promotional, accurate content. 

Even though I haven’t written a full IB yet, working with IB content has helped me understand how cross-functional teams (medical, safety, regulatory, and clinical) collaborate on critical documents that directly support trial conduct and patient safety. 

Final Thoughts 

The Investigator’s Brochure is much more than a scientific summary. The central document ensures investigators are informed, patients are protected, and regulatory bodies can track emerging evidence. 

As I build my foundation in regulatory writing, I’m learning that documents like the IB don’t just support compliance; they shape the way safe, ethical, and effective trials are conducted. 

References: 

1. ICH E6 (R2) Guideline for Good Clinical Practice. Available at: https://ichgcp.net 

2. ICH E3: Structure and Content of Clinical Study Reports 

3. ABPI Code of Practice (2021). Clause 7.2. Available at: https://www.abpi.org.uk