CLNR 455 - Managing & Monitoring Clinical Trials

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This course provides both a theoretical and practical overview of the principles of managing and monitoring clinical trials. The focus will be on the role of the Clinical Research Associate (CRA) and Central Monitoring Associate (CMA), which will include activities centered on alternative monitoring strategies currently in use. Discussion topics will consist of reduced source document verification (SDV), remote monitoring, central monitoring, risk-based monitoring, triggered/targeted monitoring, and site-based monitoring of clinical trials. Every Fall Prerequisite(s): CLNR 345