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

What type of study is referred to as not conducted on human subjects?

1. Clinical Study

2. Non-Clinical Study

3. Ethical Study

4. Observational Study

The correct answer is: Non-Clinical Study

The term "Non-Clinical Study" refers to research that is conducted outside of a clinical setting and does not involve human subjects. This type of study often utilizes laboratory experiments, animal studies, or simulations to derive data and conclusions. Non-clinical studies are essential for preliminary investigations into new drugs, treatments, or medical devices, allowing researchers to gather initial safety and efficacy data before proceeding to human trials. In contrast, clinical studies involve direct interaction with human participants to assess the effects of interventions, therapies, or drugs. Ethical studies pertain to the moral principles guiding research but do not define the type of subjects involved. Observational studies, on the other hand, involve observing subjects in a natural setting without manipulation or intervention but still include human subjects. Thus, the distinction of non-clinical studies is clear in that they are designed specifically to exclude human subjects from the research process.