Sponsor means 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. (21 CFR 312.3(b))