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

Which of the following required elements should be included in a clinical trial protocol?

1. The study's funding sources

2. The subject inclusion and exclusion criteria

3. The length of participant follow-up

4. The trial's anticipated outcomes

The correct answer is: The subject inclusion and exclusion criteria

Including the subject inclusion and exclusion criteria in a clinical trial protocol is essential for several reasons. These criteria define the specific characteristics that potential participants must meet in order to be enrolled in the study, as well as the characteristics that would disqualify them. This ensures that the trial results are applicable to the population for which the treatment is intended, while also safeguarding participants' health and well-being by preventing vulnerable groups from being enrolled inadvertently. Inclusion criteria help in identifying individuals who possess the necessary health conditions or characteristics, while exclusion criteria are equally important as they help in identifying those who may have contraindications or other factors that could confound the study results. Establishing clear criteria helps ensure the reliability and validity of the trial, facilitating a better understanding of how the intervention performs across different populations. While the other elements mentioned, such as the study's funding sources, length of participant follow-up, and anticipated outcomes, are also important components of a clinical trial protocol, the inclusion and exclusion criteria are fundamental to the integrity and ethical considerations of the study itself.