Good Clinical Practice (GCP) Practice Exam

Who typically oversees and directs the work of subinvestigators?

1. The regulatory authority

2. The main investigator of the clinical trial

3. The sponsor of the trial

4. The clinical research coordinator

The correct answer is: The main investigator of the clinical trial

The main investigator of the clinical trial, often referred to as the Principal Investigator (PI), plays a crucial role in overseeing and directing the activities of subinvestigators. This oversight is vital to ensure that the study is conducted according to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The PI is responsible for the overall conduct of the trial, including the recruitment of participants, the integrity of the data collected, and the safety of the participants. Subinvestigators, who may take on specific tasks and responsibilities within the trial, operate under the supervision and direction of the main investigator. The PI ensures that all team members are well-informed, properly trained, and adhere to ethical standards throughout the trial process. This leadership structure is essential for maintaining the quality and validity of the research, as well as safeguarding the rights and welfare of participants involved in the study. Other options, such as the regulatory authority, sponsor of the trial, or the clinical research coordinator, play different roles in the clinical trial process. The regulatory authority mainly monitors compliance and ensures safety but does not directly oversee the work of subinvestigators. The sponsor may provide funding and resources but does not directly manage day-to-day trial operations. The clinical research