Certified Clinical Research Coordinator (CCRC) Practice Exam

Who is responsible for the conduct of a clinical trial at a trial site?

1. The regulatory body overseeing the trial

2. The independent ethics committee

3. The investigator or Principal Investigator (PI)

4. The sponsor of the trial

The correct answer is: The investigator or Principal Investigator (PI)

The Principal Investigator (PI) holds the primary responsibility for the conduct of a clinical trial at a trial site. This individual is typically a qualified medical professional who leads the research team and ensures that the study is conducted according to the protocol, regulatory requirements, and ethical standards. The PI plays a crucial role in overseeing the daily operations of the trial, managing trial staff, making decisions about patient care, and ensuring participant safety. One of the key responsibilities of the PI is to maintain compliance with Good Clinical Practice (GCP) guidelines, which include the protection of the rights and welfare of trial participants, the integrity of the data generated, and adherence to the specified trial protocol. This level of oversight and accountability underscores the significant role of the PI in clinical research. Other options identify important stakeholders or entities involved in clinical trials but do not directly assume responsibility for conducting the trial at the site. The regulatory body oversees compliance and safety but does not manage daily trial activities. The independent ethics committee reviews the trial protocol and monitors ethical compliance but does not conduct the study. The sponsor funds and supports the trial, but ultimate responsibility for conduct rests with the PI at the site.