Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which document provides prior clinical and nonclinical results of investigational products (IP) to the investigator?

1. Clinical trial agreement

2. Investigator's brochure

3. Study protocol

4. Ethics committee report

The correct answer is: Investigator's brochure

The Investigator's Brochure is a comprehensive document that provides critical information about an investigational product (IP). It is designed to inform the investigator and healthcare professionals involved in the clinical trial about the prior clinical and nonclinical results associated with the IP. This document contains essential data such as pharmacology, toxicology, and previous study outcomes that could affect the safety and efficacy evaluation of the product. The information presented in the Investigator's Brochure is crucial for enabling investigators to understand the background of the investigational product, assess the risk-benefit profile, and make informed decisions regarding participant safety and dosage during the trial. This foundation of knowledge is essential for the ethical conduct of clinical research, ensuring that investigators are well-equipped with relevant background information before participating in a study. In contrast, other options like the Clinical Trial Agreement relate more to the legal and operational aspects of conducting a trial, while the Study Protocol outlines the design and methodology of the study without providing prior results. An Ethics Committee Report typically focuses on the ethical considerations of a specific study rather than on providing historical data about the investigational product itself.