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Sponsorship & Funding
Published on Jun 14, 2022 · Last Updated 1 year 6 months ago
It is important to make the distinction between the study funder and the study sponsor; the terms are not synonymous. Although widely used in connection with the funding of research projects, the term sponsor conveys a different meaning in the context of FDA-regulated research. The sponsor is the individual or entity that is responsible for the oversight of the clinical trial and for all communications with the FDA.
21 CFR 312.3 states that a:
Sponsor:
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.
Sponsor-Investigator:
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.
The IRB therefore prefers to call the organization or person providing financial support for a study the funder, while the organization/person responsible for the conduct of a clinical investigation is referred to as the sponsor.
Regulatory Responsibilities of the Sponsor
The FDA delineates specific responsibilities for the study sponsor in 21 CFR 312 Subpart D. Some of the highlights of those responsibilities are listed below:
- §312.50 choosing "qualified investigators", "ensuring proper monitoring of the investigation" and "ensuring that the FDA and all participating investigators are promptly informed of significant new adverse events or risks" ;
- §312.52 that any transfer of responsibilities are done appropriately;
- §312.53 that investigators and monitors who are elected are qualified by training and experience and who commit to uphold all required responsibilities;