Defining Clinical Investigation with Human Subjects

The U.S. Food and Drug Administration (FDA) regulations for the protection of human subjects in clinical investigations apply to clinical investigations involving a human subject.

Clinical Investigation

A clinical investigation is any experiment that involves a test article and one or more human subjects, and that either requires prior submission to the FDA or when the results will be used to support an application for a research or marketing permit. A test article means any drug including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to FDA oversight.

Human Subject

A human subject is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either healthy or a patient.

Contact the MSU HRPP Compliance Office with Questions

Application of the definitions for clinical investigations involving human subjects to certain activities is not always straightforward. Contact the Compliance Office with any questions.