Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 121

A 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).

Trial subjects are needed for a clinical trial to receive the investigational product to obtain data to evaluate the safety and efficacy of the investigational product for eventual approval of the product to diagnose, treat, cure, prevent diseases. The trial subject will be administered the investigational product at the clinical research facility by the investigator or a qualified designee.