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 evidence supporting the proposed trial.

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) to ensure that they are informed about the potential risks and benefits of the product(s). The IB is intended to assist the investigators in making their own judgement about the potential risks and benefits of the product(s) and to provide them with the information they need to conduct the trial safely and effectively.

Content

The content of the Investigator's Brochure typically includes:

• A brief description of the investigational product(s)
• A summary of the findings from non-clinical studies
• A summary of the findings from previous clinical trials
• A description of the possible risks and side effects
• A description of the proposed clinical trial, including the study design, the proposed dose and route of administration, and the proposed duration of treatment
• Information on the manufacturing and control of the investigational product(s)

Updates

The Investigator's Brochure should be updated regularly to reflect new findings from ongoing non-clinical and clinical studies. The updates should be provided to all investigators involved in the trial, as well as to the relevant regulatory authorities.

Regulatory Requirements

The preparation and content of the Investigator's Brochure is regulated by various international guidelines, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The ICH guidelines specify that the IB should be a "concise, simple, objective, balanced, non-promotional summary that is designed to assist the investigator in assessing the appropriateness of the proposed trial".

See Also

• Clinical trial
• Clinical study design
• Pharmaceutical industry
• Regulatory affairs (drugs)

Investigator's Brochure Resources
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