Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 91

The Clinical Investigator is the qualified doctor (or dentist) who administers the investigational product to the research subjects. By definition, an Investigator is:

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (ICH E6(R2) 1.57).

A clinical Investigator is the physician who has access to and gives medical care to the research participant who is being administered the investigational product, or the control product, in the clinic. The clinic where the research participant is seen by the physician and undergoes trial procedures is known as the trial site. The Investigator can be practicing alone, be part of a clinical group practice or clinical research management organization, or a member in a hospital or other institution. Any of the different types of practices can be private or public.

In all situations, the Investigator will have responsibility for the medical care of the research participant and all activities of the trial at the trial site, regardless of who actually conducts those activities. If there are other individuals, such as a nurse, laboratory technician or other physicians, who conduct the trial procedures, the Investigator leading the team is typically called the Principal Investigator, and is legally responsible for the work of all those individuals and all trial conduct at the trial site.