Clinical Investigation

-any study in which a test article (i.e., drug) is administered, dispensed to, or used, involving one or more human subjects;
OR

-Research involving “one or more subjects to determine the safety and/or effectiveness of a device.”

21 CFR 50.3(c), 21 CFR 56.102(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)