Certified Clinical Research Associate (CCRA) Practice Exam

Who is a Sponsor-Investigator?

1. Only the individual responsible for funding

2. The person who monitors the clinical investigation

3. An individual who initiates and conducts the investigation

4. A regulatory body overseeing the process

The correct answer is: An individual who initiates and conducts the investigation

A Sponsor-Investigator is defined as an individual who initiates and conducts a clinical investigation. This person takes on the dual role of both sponsoring the study and overseeing its execution, which includes assuming responsibility for the design, management, and adherence to regulatory standards throughout the clinical trial. When understanding this definition, it's essential to recognize that the role encompasses both the organizational aspects of sponsorship—like providing funding and ensuring that ethical guidelines are followed—and the hands-on activities involved in conducting the investigation, including subject recruitment and data collection. The other choices do not accurately represent the concept of a Sponsor-Investigator. For example, simply being responsible for funding does not encompass the full range of responsibilities involved in conducting the study. Similarly, monitoring the clinical investigation is usually the responsibility of a clinical trial monitor or Clinical Research Associate, not the Investigator directly. Lastly, regulatory bodies, while essential in overseeing compliance and safety in clinical trials, are separate entities and do not conduct investigations themselves. Thus, the definition of a Sponsor-Investigator is comprehensive, highlighting the critical fusion of sponsorship and investigational conduct within clinical research.