ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Monitor

Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor’s duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study.

Publication Source: Committees on Human Research

See also: CRA

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