Good Clinical Practice (GCP) Practice Exam

What is the primary purpose of an Investigator's Brochure in clinical trials?

1. A compilation of clinical and nonclinical data on the investigational product(s)

2. A detailed budget for the clinical trial

3. A marketing plan for the investigational product(s)

4. A recruitment strategy for trial participants

The correct answer is: A compilation of clinical and nonclinical data on the investigational product(s)

The primary purpose of an Investigator's Brochure is indeed to serve as a comprehensive compilation of clinical and nonclinical data on the investigational product(s). This document provides vital information to investigators and their staff regarding the product's safety, efficacy, dosing, and potential risks, which is essential for understanding the investigational therapy's profile. The information contained in the Investigator's Brochure is intended to help researchers make informed decisions during the trial and ensure adherence to Good Clinical Practice guidelines. This documentation is critical for educating the clinical trial team about the investigational product, establishing a foundation for ethical conduct in research, and ensuring that all participants receive appropriate care based on the most current knowledge about the product being tested. By providing a detailed overview of previously conducted studies and existing data, the Investigator's Brochure helps ensure the trial's integrity and the safety of the participants involved.