Who is a "sponsor-investigator" in clinical trials?

A "sponsor-investigator" refers to an individual who not only initiates the clinical trial but also takes responsibility for conducting the study. This dual role distinguishes them from other parties involved in clinical trials. The sponsor aspect indicates that they are overseeing the trial, ensuring compliance with regulatory requirements, and managing the study's funding and resources. The investigator role signifies their active participation in the research process, which includes participant recruitment, conducting the trial procedures, collecting data, and ensuring the study adheres to the protocol.

In contrast, the other options describe roles that do not encapsulate the full scope of a sponsor-investigator's responsibilities. For example, recruiting patients is a vital component of conducting a study but does not represent the dual role of initiating and conducting it. Approving the research budget is an essential task but does not encompass the operational responsibilities of conducting the study. Monitoring data analysis is critical for assessing the integrity of trial data but does not involve initiating or conducting the research. Thus, the definition of a sponsor-investigator is best captured by the role of initiating and conducting the study together.