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

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the investigational product (IP)?

Clinical Study Report
Informed Consent Form
Investigator's Brochure (IB)
Study Protocol

The correct answer is: Investigator's Brochure (IB)

The Investigator's Brochure (IB) serves as a comprehensive document that provides essential information about an investigational product (IP) to those involved in clinical trials. It includes detailed background information on the IP, including results from previous clinical and nonclinical studies. The IB summarizes both safety and efficacy data, mechanisms of action, pharmacokinetics, and the anticipated effects on human subjects. This document is crucial for investigators as it highlights critical information that can inform their understanding of the drug's profile and how it may perform in the proposed study. It also aids in ensuring that ethical considerations are met and that the study design is aligned with the known characteristics of the product. While the other options serve important roles in clinical research—such as providing detailed protocols for conducting the study or informing participants of their rights—the IB specifically aggregates and highlights all prior findings relevant to the investigational product, making it the primary reference for past results.