Investigator's brochure
Investigator's Brochure
Investigator's Brochure (pronunciation: in-ves-ti-ga-tor's bro-shure) is a comprehensive document compiled for the purpose of briefing the investigators and participants of a clinical trial about the significant aspects of the investigational product(s). The document is a key part of the Clinical Trial Application (CTA) and is updated throughout the life-cycle of the trial.
Etymology
The term "Investigator's Brochure" is derived from the role it plays in providing investigators with detailed information about the investigational product. The term "brochure" is used to denote a type of booklet designed to provide information or advertise something, in this case, the investigational product.
Related Terms
- Clinical Trial: A research study that tests how well new medical approaches work in people.
- Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial.
- Clinical Trial Application (CTA): An application that is submitted to a regulatory authority to commence a clinical trial.
- Regulatory Authority: A public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity.
Content
The Investigator's Brochure typically includes information about the following:
- Drug Substance: Information about the physical, chemical, and pharmaceutical properties and formulation of the investigational product.
- Nonclinical Studies: Information about the pharmacological, toxicological, pharmacokinetic, and metabolic profiles of the investigational product.
- Clinical Studies: Information about the safety and effectiveness of the investigational product in humans.
- Clinical Trial Protocol: A detailed plan that sets out the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
Purpose
The primary purpose of the Investigator's Brochure is to provide clinical investigators with the information necessary to understand the rationale for, and conduct of, a trial. This includes information about the safety and efficacy of the investigational product, the design of the clinical trial, and the rights, safety, and well-being of the trial participants.
External links
- Medical encyclopedia article on Investigator's brochure
- Wikipedia's article - Investigator's brochure
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