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

Which element is essential to include in a clinical trial protocol?

1. Study funding sources

2. Subject inclusion and exclusion criteria

3. Statistical analysis plan

4. Institutional affiliations

The correct answer is: Subject inclusion and exclusion criteria

Including subject inclusion and exclusion criteria in a clinical trial protocol is crucial because these criteria dictate the specific characteristics of individuals who can participate in the study. These criteria guide the selection of a participant population that is appropriate for the research objectives and the safety of both participants and the integrity of the data collected. Clearly defined criteria ensure that the trial meets ethical standards and regulatory requirements, as they help identify individuals who are most likely to benefit from the intervention and minimize risks associated with participation. Additionally, well-defined inclusion and exclusion criteria contribute to the study's validity by preventing confounding variables that could affect the outcomes. While other elements, such as study funding sources, statistical analysis plans, and institutional affiliations, are important components of a clinical trial protocol, the inclusion and exclusion criteria are fundamental to participant recruitment and the overall design of the trial. This is essential for ensuring that the results are applicable to the intended patient population and that the study rigorously tests the hypothesis it aims to evaluate.