The investigator brochure compiles the clinical and nonclinical data on an investigational product so investigators can understand the rationale for the protocol and manage safety. This template follows the section structure in ICH E6 and tells you what to put in each part, in our own wording.
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Title page and confidentiality
Summary
Two pages
Nonclinical studies
Tox update pending
Effects in humans
Summary of data and guidance for the investigator
Reference list and change log
Key points
Do you need one
The sponsor writes the IB. For a commercial sponsor with a new compound, that is a regulatory writing team drawing on toxicology, pharmacology, clinical and CMC reports. For an academic sponsor or a sponsor-investigator working with a novel product, it falls to the study team and the product's developer, and the task is much bigger than the template suggests, because the data must come from someone who owns them. See how to become a sponsor-investigator.
If the product is already authorised and used within its approved indication, regulators commonly allow the approved product information, such as a summary of product characteristics or a prescribing label, to serve in place of an IB. Use outside the label usually needs more. Whether a substitute is acceptable depends on your jurisdiction and the competent authority and ethics committee for your trial, so confirm it in writing before you rely on it.
The IB is a living document. Each edition is dated and numbered, changes since the last edition are summarised, and investigators receive each update through the sponsor. The protocol refers to the IB, and the consent form should be consistent with it. For the protocol, see the clinical trial protocol template and the protocol glossary entry. The harmonised protocol format is covered in the ICH M11 guide.
Template
The headings follow the structure in ICH E6. The guidance is written for this page. Use your product's data and your regulator's requirements to fill them. Check the current ICH E6 text and any region-specific rules.
| Section | What to include | Guidance and common pitfalls |
|---|---|---|
| Title page | Sponsor name, product identifier, edition number and date, replacement of the previous edition. | Make the edition and date unmistakable. Investigators must know they hold the current one. |
| Confidentiality statement | That the document is confidential and for the investigator and ethics committee. | Align with your agreements. Keep it short. |
| Table of contents | Sections and appendices with page numbers. | Include the change log and the reference list. |
| Summary | A short statement of the key physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information relevant to the stage of development. | Keep it brief; the guideline text we reviewed suggests around two pages at most. Write it last, from the finished sections. |
| Introduction | The product's name, class, rationale for research, and the indications anticipated. | State why the product is being studied. Avoid promotional language. |
| Physical, chemical and pharmaceutical properties and formulation | Description of the substance and product, structural formula, formulation, storage and handling. | Include what site pharmacy needs: storage, stability, handling hazards. Link to the pharmacy manual. |
| Nonclinical studies | Pharmacology, pharmacokinetics and metabolism in animals, and toxicology, with the doses and findings that matter for human use. | Summarise, do not paste study reports. Cover findings that drive protocol safety monitoring. |
| Effects in humans | Human pharmacokinetics and metabolism, safety and tolerability, efficacy, and any marketing experience. | Present by population and dose. Use tables for adverse events. Make clear which data are from controlled studies. |
| Summary of data and guidance for the investigator | An integrated overview of the nonclinical and clinical data, with an interpretation of the information for the investigator, including expected risks, adverse reactions and special precautions. | This is the section investigators read. Tell them what to watch for, which events are expected and what to do. |
| Reference list and appendices | Publications and reports cited, and any appendices such as a reference safety information table. | Keep a clear, dated list of what the edition relied on. |
| Change log | What changed since the previous edition, in plain terms. | A table of date, section and change is enough. It is what investigators and ethics committees actually read. |
Headings reflect the ICH E6 structure; wording is ours. Do not copy another sponsor's IB, since it contains their data and confidential information.
Writing it well
A good IB lets an investigator who has not seen the underlying reports understand the product, its risks and why the protocol is built as it is. Write each section so the next one can lean on it: the nonclinical findings explain the safety monitoring, the human data explain the dose, and the guidance section ties them to the visits in the protocol.
Treat the safety information as the most perishable part. When new significant information arrives, such as a new serious adverse reaction type, the sponsor should not wait for the next scheduled edition to tell investigators. Many sponsors maintain a separate reference safety information section so they can update expectedness without reissuing every chapter. Feed the process from your safety reporting: see the SAE reporting timelines guide.
Number each edition, keep every edition, record the date each site received it and the date the ethics committee was informed. The receipt dates belong in the master file and the site file; see the essential documents checklist.
Risks in the consent form should match the brochure. When the IB changes the expected risks, review whether the consent form and the protocol safety section need amendment too.
months
Collect new reports
Write, review, approve
Sites confirm receipt
As rules require
If new significant risk
Build the safety and adverse event forms the protocol asks for in the free sandbox, then test the edit checks and the audit trail. Free sandbox, every feature, no credit card.
How to use it
Check whether your product is authorised and the use is within label. If so, ask the regulator and ethics committee whether the approved product information will do.
Chemistry and manufacturing summaries, nonclinical study reports, clinical study reports or publications. If you do not own the data, get written permission to summarise them.
Physical and chemical properties, nonclinical, effects in humans. Build tables for pharmacokinetics and adverse events.
Interpret the evidence for the investigator: expected risks, precautions, monitoring suggestions, what to report.
They draw on the finished sections. Keep the summary brief.
Clinician, toxicologist, pharmacist, safety lead and a regulatory reader. Compare with the draft protocol and consent form for consistency.
Number the edition, send it to investigators, record receipt, inform ethics committees as required, and file in the master and site files.
In Capture
Capture does not author or host investigator brochures; that is a regulatory writing task and the document belongs in your master file. What the IB does shape is the study build: the safety and adverse event forms, the laboratory monitoring and the visit schedule. Capture's AI study builder can read a protocol (PDF, DOCX or DOC) and draft the visit schedule and forms for review, and nothing is saved without human review.
Event term
AETERMSeverity
AESEVRelated to study product
AERELAESI per protocol: notify safety lead
Before you issue it
IB required, or an approved product information accepted in writing.
Edition number, date, sponsor, product, and replaced edition.
Summary, introduction, properties and formulation, nonclinical, human effects, guidance.
Matches the body, and nothing is introduced only there.
Written permission where the data belong to someone else.
Expected risks, precautions and reporting expectations.
Risks, dose and monitoring match.
What changed since the last edition.
Date each site received this edition, filed in the master and site file.
An investigator brochure (IB) is a compilation of the clinical and nonclinical data on an investigational product that are relevant to its study in humans. It is written by the sponsor to help investigators understand the rationale for the protocol and manage the product safely.
The ICH E6 structure covers a summary, an introduction, physical, chemical and pharmaceutical properties and formulation, nonclinical studies, effects in humans, and a summary of data and guidance for the investigator, plus references and appendices.
The sponsor. In commercial trials a regulatory writing team does it. In academic or sponsor-investigator trials the study team writes it, drawing on data from the product's developer, with permission.
Often, for an authorised product used within its approved indication, regulators accept the approved product information. Use outside the label usually calls for more. Confirm with your regulator, sponsor and ethics committee.
ICH E6 expects regular review and revision as new information arrives, which we read as at least annually. Significant new safety information should reach investigators promptly and not wait for the next edition. Check the current text.
Yes. It is one of the essential documents held by both sponsor and investigator, with the edition history and the dates sites received each edition. See the essential documents checklist.
No. Capture is an EDC and trial platform, not a regulatory writing or document management tool. It helps with the study build that follows from the IB, such as safety forms and edit checks.
Keep exploring
Essential documents checklist
Where the IB sits among the other records.
Clinical trial protocol template
The document that refers to the IB.
ICH M11 guide
The harmonised protocol format.
How to become a sponsor-investigator
Who owns the IB in investigator-led trials.
SAE reporting timelines guide
The safety information that updates the IB.
Adverse event eCRF template
A form to adapt to the IB's monitoring guidance.
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