Final answer:
A sponsor-investigator is the individual who initiates and conducts a clinical trial and oversees the administration of the investigational product to research subjects according to ICH E6.
Step-by-step explanation:
According to a definition used in ICH E6, an individual (not a corporation or agency) who both initiates and conducts a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a research subject is a sponsor-investigator.
Clinical trial coordinators manage the proceedings of the clinical trial but do not initiate and conduct trials. They coordinate patient schedules, maintain detailed notes, build the patient database, ensure proper documentation, and work with nurses and doctors to facilitate the trial.
On the other hand, it is the sponsor-investigators who bear responsibility for not only initiating and planning the trial but also for the management and regulatory compliance, including the application to regulatory bodies like the FDA.