• The company/person who initiates the study. The sponsor is typically the manufacturer or research institute that developed the drug or device. In this case, the sponsor does not actually conduct the clinical trial but rather distributes the investigational drug or device to clinical investigators who direct local conduct of the trial. A clinical investigator may, however, serve as both the sponsor and investigator (investigator-sponsor) of a clinical trial. The sponsor assumes general responsibility for the studies involving the investigational drug or device, including responsibility for compliance with applicable laws and regulations. The sponsor is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.
  • A person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than that individual (e.g., a corporation or an agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (FDA)