Certified Clinical Research Coordinator (CCRC) Practice Exam

What do non-clinical studies not involve?

1. Animal subjects

2. Human subjects

3. Controlled environments

4. Longitudinal research

The correct answer is: Human subjects

Non-clinical studies are primarily characterized by their focus on testing and evaluation that does not include human subjects. These studies often aim to gather preliminary data about safety, efficacy, pharmacokinetics, and pharmacodynamics through the use of in vitro (test tube) experiments or animal models. By excluding human subjects, non-clinical studies help researchers understand basic biological processes and potential effects of compounds before moving to studies that involve actual patients. This separation is crucial as it allows researchers to evaluate hypotheses and safety profiles without the ethical complexities and risks associated with human testing. For instance, animal subjects, controlled environments, and longitudinal research can all be components of non-clinical studies. Researchers commonly use animal models to monitor the long-term effects of treatments over time or to assess reactions within a controlled setting. Thus, the defining factor that distinguishes non-clinical studies is their lack of direct involvement with human subjects.