Investigator's brochure

Investigator's Brochure (IB) is a compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the product(s) in human subjects. The document is a critical part of the approval process for clinical trials, providing investigators and others involved in the trial with information about the investigational product(s) and the conduct of the study.

Purpose

The purpose of the Investigator's Brochure is to provide the investigators and participants of a clinical trial with information about the investigational product(s) and the conduct of the study. It is designed to assist the investigators in making their own assessment of the potential risks and benefits of the investigational product(s) in the context of the proposed study.

Content

The content of the Investigator's Brochure should include the following sections:

• Title Page: This should include the title, the name of the investigational product(s), the name and address of the sponsor, and the date of the brochure.

• Table of Contents: This should list all the sections and subsections of the brochure, along with their respective page numbers.

• Summary: This should provide a brief overview of the investigational product(s) and the proposed study.

• Introduction: This should provide background information on the investigational product(s) and the rationale for the proposed study.

• Physical, Chemical, and Pharmaceutical Properties and Formulation: This should provide information on the physical, chemical, and pharmaceutical properties of the investigational product(s), as well as the formulation of the product(s).

• Nonclinical Studies: This should provide a summary of the nonclinical studies conducted with the investigational product(s), including the results of these studies.

• Effects in Humans: This should provide a summary of the effects of the investigational product(s) in humans, based on previous clinical trials and other studies.

• Proposed Clinical Studies: This should provide a detailed description of the proposed clinical studies, including the study design, the study population, the study procedures, and the study endpoints.

• References: This should list all the references cited in the brochure.

Updates

The Investigator's Brochure should be updated regularly to reflect new information about the investigational product(s) or the conduct of the study. The updates should be provided to all investigators involved in the study, as well as to the relevant regulatory authorities.

Investigator's brochure Resources
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