SOCRA CCRP Practice Exam

How is an investigator defined per FDA regulations?

1. The sponsor of the clinical investigation

2. The individual who conducts the clinical investigation

3. A member of the clinical investigator’s team

4. The regulatory body overseeing the investigation

The correct answer is: The individual who conducts the clinical investigation

An investigator is defined as the individual who conducts the clinical investigation. This person is responsible for the overall conduct, management, and oversight of the study. They are also responsible for ensuring that the study is conducted in compliance with all applicable FDA regulations and guidelines. Options A, C, and D are incorrect because they do not accurately reflect the role and responsibilities of an investigator as defined by FDA regulations. A sponsor is responsible for providing the funding and resources for the investigation, but they do not conduct the study themselves. Option C, a member of the clinical investigator's team, may assist in the study, but they are not the primary individual responsible for conducting it. Option D, a regulatory body, oversees the investigation, but they are not the one actively conducting it. Therefore, the correct answer is to be B.