Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 92

The Subject/Trial Subject is a human who volunteers to participate in the clinical trial to receive the investigational product or control product. By definition, the Subject/Trial Subject is:

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH E6(R2) 1.57)

The human research subject or Trial Subject, also known as clinical research subject, participant, or volunteer, is the individual who volunteers to participate in the clinical trial to receive the investigational product or to act as a control in the trial. The volunteer will be an individual from the population being studied in the trial; therefore, research participants can be healthy volunteers or someone who has the disease under study, and can be of any age, race, or gender. For all Trial Subjects, participation in a clinical trial is voluntary. The term Subject or Trial Subject is generally used to describe the person once they consent to being in a trial, although some prefer “patients” to refer to individuals who have the disease. Others also prefer the neutral term “volunteer” or participant' to refer to all types of trial participants.