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

Who is ultimately responsible for all aspects of the research conducted at a site?

1. Research coordinator

2. Principal investigator

3. Study sponsors

4. Ethics review board

The correct answer is: Principal investigator

The principal investigator holds the ultimate responsibility for all aspects of the research conducted at a site. This role involves overseeing the entire study, ensuring that it is conducted in accordance with regulatory guidelines, ethical standards, and the approved protocol. The principal investigator makes critical decisions about the research design and methodology, data integrity, participant safety, and compliance with ethical considerations. This individual is not only accountable for the day-to-day management of the research team and activities but also for adhering to the institutional and regulatory requirements that govern research. As such, they serve as the primary point of contact for interactions with the ethics review board, research sponsors, and all other stakeholders involved in the study. In this context, the research coordinator assists the principal investigator in managing the activities but does not hold the same level of responsibility. Study sponsors provide funding and resources but are not directly involved in the day-to-day management. The ethics review board ensures the study complies with ethical standards but does not take responsibility for the conduct of the research itself. Therefore, the principal investigator is indeed the key figure responsible for the overall integrity and execution of the research.