ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Investigator

In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of an investigator.

Publication Source: Committees on Human Research

See also: Principal Investigator

Investigator

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.

Publication Source: ISPE Good Practice Guide: Booklet Labels
Publication Date: 2013

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