Investigator’s Brochure - Template

Sep 1, 2026

Investigator’s Brochure (IB) template outlining sponsor identification of each investigational product, including research number, chemical or approved generic name, and permitted trade names, along with edition and release date details. Provides a structured framework for documenting the development rationale, physical/chemical/pharmaceutical properties, nonclinical studies, and human effects covering pharmacokinetics, pharmacodynamics, efficacy, and safety including evaluations, adverse events, and laboratory assessments. Includes marketing experience, investigator guidance, and appendices for reference safety information and clinical study tables.

LanguageEnglish

CategoryForms

FormatDOCX

Pages41

Reading Time14 min

AccessFree to download

INVESTIGATOR’S BROCHURE

SYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE

OVERVIEW

Product Summary

Development Rationale

PHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION

Drug Substance

Drug Product

Formulation

Labeling, Storage, and Handling

Stability

NONCLINICAL STUDIES

Overview

Detailed Non-Clinical Study Description

EFFECTS IN HUMANS

Overview

Clinical Studies

Clinical Pharmacology

Pharmacokinetics in Subjects

Other Pharmacokinetic Analyses

Clinical Pharmacodynamics

Efficacy in Subjects

Demographics and Baseline Characteristics

Time to Clinical Worsening

Survival

Safety

Safety Evaluations, Methodology and Definitions

Adverse Events

Deaths, Serious Adverse Events, and Discontinuations Due to Adverse Events

Clinical Laboratory Evaluations

Other Safety Evaluations

MARKETING EXPERIENCE

GUIDANCE FOR THE INVESTIGATORS

Indication

Product

Safety

Infusion of T-cells

Transduction

Cross-Reactivity with Normal Tissues

CRS

MAS

Tumor Lysis Syndrome

Development of Human Anti-Mouse Antibody (HAMA)

Clinical Studies

Appendix 1. REFERNCE SAFETY INFORMATION (RSI)

Appendix 2. TABULAR SUMMARY OF CLINICAL STUDIES

1.14.4.1 INVESTIGATOR’S BROCHURE This should provide the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. An example is given in Appendix 1. MACROBUTTON EmptyMacro [Insert Study Drug Name Here] DATE \@ "d MMMM yyyy" \* MERGEFORMAT 1 September 2026 Lineberger Comprehensive Cancer Center University of North Carolina 450 West Drive, CB 7295 Chapel Hill, NC 27599 Edition: MACROBUTTON AcceptAllChangesInDocAndStopTracking "[Insert Edition Number Here]" Release Date: MACROBUTTON AcceptAllChangesInDocAndStopTracking "[Insert Release Date Here]" SYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE MACROBUTTON EmptyMacro [Insert Product Name]Edition #: DATE \@ "d MMMM yyyy" \* MERGEFORMAT 1 September 2026 MACROBUTTON EmptyMacro [Insert synopsis of changes since previous version. If none, delete this page.] Overall Risk-Benefit With the changes introduced in this edition of the IB, the risk/benefit assessment TABLE OF CONTENTS TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc529271435" 1 OVERVIEW PAGEREF _Toc529271435 \h 10 HYPERLINK \l "_Toc529271436" 1.1 Product Summary PAGEREF _Toc529271436 \h 10 HYPERLINK \l "_Toc529271437" 1.1.1 Development Rationale PAGEREF _Toc529271437 \h 10 HYPERLINK \l "_Toc529271438" 2 PHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION PAGEREF _Toc529271438 \h 11 HYPERLINK \l "_Toc529271439" 2.1 Drug Substance PAGEREF _Toc529271439 \h 11 HYPERLINK \l "_Toc529271440" 2.2 Drug Product PAGEREF _Toc529271440 \h 11 HYPERLINK \l "_Toc529271441" 2.2.1 Formulation PAGEREF _Toc529271441 \h 11 HYPERLINK \l "_Toc529271442" 2.2.2 Labeling, Storage, and Handling PAGEREF _Toc529271442 \h 11 HYPERLINK \l "_Toc529271443" 2.2.3 Stability PAGEREF _Toc529271443 \h 14 HYPERLINK \l "_Toc529271444" 3 NONCLINICAL STUDIES PAGEREF _Toc529271444 \h 15 HYPERLINK \l "_Toc529271445" 3.1 Overview PAGEREF _Toc529271445 \h 15 HYPERLINK \l "_Toc529271446" 3.2 Detailed Non-Clinical Study Description PAGEREF _Toc529271446 \h 15 HYPERLINK \l "_Toc529271447" 4 EFFECTS IN HUMANS PAGEREF _Toc529271447 \h 16 HYPERLINK \l "_Toc529271448" 4.1 Overview PAGEREF _Toc529271448 \h 16 HYPERLINK \l "_Toc529271449" 4.1.1 Clinical Studies PAGEREF _Toc529271449 \h 16 HYPERLINK \l "_Toc529271450" 4.2 Clinical Pharmacology PAGEREF _Toc529271450 \h 16 HYPERLINK \l "_Toc529271451" 4.2.1 Pharmacokinetics in Subjects PAGEREF _Toc529271451 \h 16 HYPERLINK \l "_Toc529271452" 4.2.2 Other Pharmacokinetic Analyses PAGEREF _Toc529271452 \h 16 HYPERLINK \l "_Toc529271453" 4.2.3 Clinical Pharmacodynamics PAGEREF _Toc529271453 \h 16 HYPERLINK \l "_Toc529271454" 4.3 Efficacy in Subjects PAGEREF _Toc529271454 \h 16 HYPERLINK \l "_Toc529271455" 4.3.1 Demographics and Baseline Characteristics PAGEREF _Toc529271455 \h 16 HYPERLINK \l "_Toc529271456" 4.3.2 Time to Clinical Worsening PAGEREF _Toc529271456 \h 17 HYPERLINK \l "_Toc529271457" 4.3.3 Survival PAGEREF _Toc529271457 \h 17 HYPERLINK \l "_Toc529271458" 4.4 Safety PAGEREF _Toc529271458 \h 17 HYPERLINK \l "_Toc529271459" 4.4.1 Safety Evaluations Methodology and Definitions PAGEREF _Toc529271459 \h 17 HYPERLINK \l "_Toc529271460" 4.4.2 Adverse Events PAGEREF _Toc529271460 \h 17 HYPERLINK \l "_Toc529271461" 4.4.3 Deaths, Serious Adverse Events, and Discontinuations Due to Adverse Events PAGEREF _Toc529271461 \h 18 HYPERLINK \l "_Toc529271462" 4.4.4 Clinical Laboratory Evaluations PAGEREF _Toc529271462 \h 18 HYPERLINK \l "_Toc529271463" 4.4.5 Other Safety Evaluations PAGEREF

FAQs

What key identifiers must be provided for each investigational product in the Investigator’s Brochure?

Provide the sponsor’s name and the identity of each investigational product, including the research number, chemical or approved generic name, and any trade names where legally permissible.

Why should an edition number and a release date be included?

The template recommends including an edition number and the release date, along with a reference to the prior edition that the new edition supersedes, to support version control.

What sections are required to describe effects in humans?

The template organizes human information into clinical pharmacology and efficacy, plus safety details such as adverse events, deaths/serious adverse events/discontinuations due to adverse events, and clinical laboratory evaluations.

Sep 1, 2026

Upload by Felix Montgomery