Definitions for "Monitor" Add To Word List
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Keywords: Cro, Cra, Sponsor, Oversee, Clinical
Individual employed by the sponsor or the CRO hired by the sponsor; acts as a liaison between the sponsor and the investigator of a clinical study, and oversees the progress and conduct of the trial; may also be referred to as a CRA
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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. See also CRA.
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Person employed by the sponsor or CRO who is responsible for determining that a trial 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 trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. See also clinical research associate.
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Sponsor or CRO representative who reviews study records to determine that it is being conducted according to the protocol. A monitor's duties may include helping plan and initiate a study and assessing its conduct.
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Person designated by a sponsor or contract research organization to oversee an investigation. A monitor may be an employee or a consultant to a sponsor or a contractor. Monitor also means to oversee an investigation. Go to definition 21 CFR 812 or full 21 CFR 812.
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