An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control, is called what?

• A. Trial Site
• B. Subject/Trial Subject
• C. Sponsor-Investigator
• D. Well-being (of the trial subjects)

Answer: (B)

In clinical research, the person who takes part in the trial, whether they receive the investigational product or are in the control group, is called a subject (also referred to as a trial subject). This term is used in protocols, informed consent documents, and regulatory submissions to designate the human participant in the study. It’s distinct from the trial site (the location where the study is conducted) and from roles like sponsor-investigator (the person or entity sponsoring and conducting the trial). The phrase about well-being relates to monitoring safety, not to the participant’s designation. While some contexts use “participant” in everyday language, the standard term in GCP contexts is subject/trial subject.