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

Which of the following is NOT a typical element of an investigator's brochure?

1. Clinical trial protocols

2. Preclinical data and results

3. Information about the investigational product

4. Executive summary of the budget

The correct answer is: Executive summary of the budget

An investigator's brochure is a comprehensive document that provides essential information about an investigational product to support the clinical trial process. It aims to ensure that investigators are adequately informed about the product and its rationale for use in research. The brochure typically includes detailed information about the investigational product, such as its chemical structure, pharmacology, and prior research findings. Preclinical data and results are crucial elements, as they provide insight into the safety and efficacy of the product before it is tested in humans. Additionally, clinical trial protocols are often included in some form, summarizing the intended study design, objectives, and methodology. However, the executive summary of the budget does not fit into the context of an investigator's brochure. This document is focused on scientific and clinical information rather than financial aspects of conducting the trial. Financial details, including budgeting, are generally handled separately in the context of clinical trials, making the inclusion of a budget summary unnecessary and irrelevant in the investigator's brochure.