Investigators, Sponsors, and Sponsor-Investigators

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub-investigator” includes any other individual member of that team (21 CFR 321.3).

Sponsor means a person who takes responsibility for and initiates a clinical investigation (21 CFR 312.3). 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.

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed (21 CFR 312.3). The term does not include any person other than an individual. If an academic investigator submits an IND or IDE or obtains an abbreviated IDE from the IRB and is the principal investigator, the investigator is the Sponsor-Investigator and he/she is responsible for regulatory compliance. Academic investigators sometimes equate the term “Sponsor” with the source of the study funding. In fact, there are two types of sponsors: regulatory sponsor and financial sponsor. The regulatory sponsor is the person/entity who initiates and takes responsibility for a clinical investigation. The regulatory sponsor submits the IND or IDE when applicable and is responsible for communications with the FDA. The regulatory sponsor may be a pharmaceutical company, a private or academic organization, or an individual. A financial sponsor may be a company, a department, a non-profit or a government agency. If a pharmaceutical (or device) company is supplying a drug (or device) for an academic study, but will not be submitting the IND or IDE, the company is not the regulatory sponsor. For commercial INDs, the financial and regulatory sponsors are usually the same (i.e. the pharmaceutical or device company).