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

What document outlines a research subject's responsibilities for study participation?

1. Study Protocol

2. Informed Consent Form

3. Investigator's Brochure

4. Clinical Trial Agreement

The correct answer is: Informed Consent Form

The Informed Consent Form is the document specifically designed to detail the responsibilities of a research subject participating in a study. It serves as a fundamental element of ethical research practices, ensuring that participants are fully informed about the study procedures, potential risks, benefits, and their rights throughout the duration of the trial. By signing the Informed Consent Form, participants understand what is expected of them, such as attending scheduled visits, following study protocols, and reporting any adverse events or side effects. It clarifies their obligations to comply with the study requirements and outlines how their participation contributes to the overall research goals. In contrast, the Study Protocol delineates the overall plan for the research, defining the methodology and objectives but does not specifically address the participant's individual responsibilities. The Investigator's Brochure contains essential information about the investigational product and clinical considerations but is aimed primarily at the researchers and not the subjects. The Clinical Trial Agreement is a contract between sponsors and investigators or institutions, detailing terms of the study while not focusing on the participants' roles. Thus, the Informed Consent Form uniquely addresses the responsibilities and commitments required from research subjects, making it the correct choice for this question.