What is the Role of a Sponsor in a Clinical Investigation?

Sponsorship of a clinical investigation is an important responsibility that can be assumed by an individual, a pharmaceutical company, a government agency, an academic institution, a private organization, or other organization. The sponsor is the entity or person that takes responsibility for the clinical research and initiates it. A sponsoring investigator, on the other hand, is the person who assumes responsibility as a sponsor of the clinical study and also carries out or oversees the clinical trial. It is important to note that the sponsoring investigator must meet the regulatory requirements applicable to both the sponsor and the investigator. Sponsors of clinical trials play a critical role in determining the feasibility of a clinical trial.

They are responsible for overseeing the overall design of the study, providing funding sources, and developing beneficial procedures to help guide the study to a successful outcome. IRB administrators and committee members may use the words sponsor and researcher interchangeably, but it is essential to understand the difference between them. When researchers begin designing, drafting, and implementing a clinical trial, their responsibilities are just beginning. The FDA calls these researchers “sponsoring researchers” (SIs). A sponsoring investigator is a person who initiates and carries out research and under whose immediate direction the investigational drug is administered or dispensed.

In other words, in a trial initiated by an investigator, the investigator is both the investigator and the sponsor and must therefore assume the responsibilities of both roles. The sponsor of a clinical trial is responsible for initiating, managing, or funding it. The Food and Drug Administration (FDA) defines clinical research as any experiment that includes a test article that is subject to FDA pre-submission requirements (found in sections 505 or 520 of the FDC Act) or is not subject to submission, but whose results are intended to be submitted later or to be retained for inspection as part of a research or marketing permit application (21 CFR section 50.3c). The Good Clinical Practice (GCP) guidelines also describe quality management requirements in clinical trials to further ensure the protection of participants and the reliability of trial results.