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

What is the primary purpose of non-clinical studies?

1. To develop new medical devices

2. To provide preliminary safety data for humans

3. To create public health policies

4. To test new surgical techniques

The correct answer is: To provide preliminary safety data for humans

The primary purpose of non-clinical studies is to provide preliminary safety data for humans. These studies are essential in the early phases of research and development, particularly when it comes to evaluating the safety and biological activity of new compounds, devices, or procedures before they are administered to human subjects. Non-clinical studies typically include a range of testing, such as in vitro studies, animal testing, and toxicology assessments. These investigations help identify any potential risks, side effects, or toxic reactions that might occur in humans and are crucial for determining dosage levels and treatment protocols for subsequent clinical trials. By establishing a foundational understanding of safety and efficacy, non-clinical studies serve as a critical step in the drug development process, ensuring that only those candidates that demonstrate a reasonable safety profile proceed to human testing. The other options, while related to the broader field of medical research, do not accurately reflect the primary aim of non-clinical studies. Developing new medical devices can be a part of the overall research but often involves both non-clinical and clinical phases. Similarly, creating public health policies is typically informed by data from various sources, including but not limited to clinical outcomes and epidemiological data. Testing new surgical techniques is primarily a clinical endeavor focused