An investigator is an individual who actually conducts a clinical investigation. This individual is responsible for ensuring that the clinical investigation is conducted according to the applicable regulations, Form 1572, and the protocol or investigational plan, and for ensuring the rights, welfare and safety of the study subjects are protected. The investigator is also responsible for the control of the investigational product and that adequate records are maintained. If the clinical investigation is conducted by a team of individuals, the investigator is responsible to lead and oversee that team, ensuring the team members follow the regulations and protocol, and that the team members are qualified by training, knowledge and experience to carry out their respective study tasks.
Although clinical investigators are often physicians, there is no requirement that the investigator must be a physician. The investigator must be qualified by training, knowledge and experience.