Sponsor-investigator
An investigator who assumes the dual role of the sponsor and the investigator by conceiving, initiating, and conducting their own Investigator-Initiated Trial (IIT). The Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH) defines sponsor-investigator as follows:
Sponsor-Investigator (FDA IND): An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor. FDA: 21 CFR 312.3, Definitions and Interpretations
Sponsor-Investigator (FDA IDE): An individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator under this part include those of an investigator and those of a sponsor. FDA: 21 CFR 812.3, Definitions
Sponsor-Investigator (ICH GCP): An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. ICH GCP, 1.54
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