Investigator's Brochure

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Investigator's Brochure

Investigator's Brochure (pronunciation: In-ves-ti-ga-tor's Bro-chure) is a comprehensive document compiled by the sponsor of a clinical trial that provides detailed information about the investigational product(s). The document is intended to provide the clinical investigators with the necessary information to understand the rationale for, and conduct of, a proposed investigation.

Etymology

The term "Investigator's Brochure" is derived from the role of the document, which is to provide a brochure of information to the investigators involved in a clinical trial. The term is widely used in the field of clinical research.

Related Terms

  • Clinical Trial: A research study that tests how well new medical approaches work in people.
  • Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
  • Clinical Investigator: A medical researcher in charge of carrying out a clinical trial's protocol.

Content

The Investigator's Brochure typically includes the following sections:

  • Title Page: This includes the title, sponsor, and date of the document.
  • Table of Contents: An overview of the sections included in the brochure.
  • Summary: A brief summary of the investigational product, its development status, and the planned trial.
  • Introduction: This section provides background information on the investigational product and the rationale for the trial.
  • Physical, Chemical, and Pharmaceutical Properties and Formulation: Detailed information about the investigational product.
  • Nonclinical Studies: Results of in-vitro and in-vivo studies with the investigational product.
  • Effects in Humans: Results of previous clinical trials with the investigational product.
  • Summary of Data and Guidance for the Investigator: This section summarizes the data collected so far and provides guidance to the investigator on how to conduct the trial.

Purpose

The primary purpose of the Investigator's Brochure is to provide clinical investigators with information about the investigational product that is essential for the safe and effective conduct of a clinical trial. It also serves as a reference document for ethics committees, regulatory authorities, and other stakeholders involved in the trial.

External links

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