Sponsor
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study (if only responsible for the latter, the term funder may be used). Although the term sponsor is widely used in connection with the funding of research projects, it conveys a different meaning in the context of FDA-regulated research. Sponsor is defined by the Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH) as follows:
Sponsor (FDA IND): A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. FDA: 21 CFR 312.3, Definitions and Interpretations
Sponsor (FDA IDE): A person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual. A person includes any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. FDA: 21 CFR 812.3, Definitions
Sponsor of a clinical investigation (ICH GCP): An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. ICH GCP, 1.53
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