Is my project a Clinical Trial?

There are 2 definitions for clinical trial.

NIH Definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  You can find a decision tree and additional assistance on the NIH clinical study page at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials.  This decision logic does not include an FDA determination.

Find definitions for terms used in the NIH definition of Clinical Trial here.

FDA definition:  A clinical study (trial) in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.   FDA Clinical Trials generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation,meaning that the trial has one or more sites in the U.S., involves a drug, biologic, or device that is manufactured in the U.S. (or its territories), or is conducted under and investigational new drug application (IND) or investigational device exemption (IDE). 

Last updated: 2/21/2023