Good Clinical Practice (GCP) Practice Exam

What is the role of a sponsor-investigator?

1. Only to manage the clinical trial finances

2. Only to administer the investigational product

3. To both initiate and conduct the clinical trial

4. To recruit subjects for the trial

The correct answer is: To both initiate and conduct the clinical trial

The role of a sponsor-investigator is comprehensive, involving both the initiation and conduct of the clinical trial. A sponsor-investigator is an individual who takes on the responsibilities of both a study sponsor and an investigator. This dual role allows the sponsor-investigator not only to oversee the trial's design, implementation, and adherence to regulatory standards but also to actively engage in the research process, including administering the investigational product and interacting with study participants. In this capacity, the sponsor-investigator is responsible for ensuring that the study is conducted ethically and that all regulatory requirements are met. They also play a crucial part in the development of the trial protocol, management of the trial's operational aspects, and data handling. Their involvement enhances the connection between the research aims and the investigative processes, making them critical in ensuring trial integrity and scientific validity.