A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial. If a trial is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator.
Where an investigator/institution is referenced in this guideline, it describes expectations that may be applicable to the investigator and/or the institution in some regions. Where required by the applicable regulatory requirements, the “investigator” should be read as “investigator and/or the institution.”