CLNR 365 - Managing/Monitoring Clinical Trials I

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This introductory course has been designed to provide a theoretical and practical overview of the principles of managing and monitoring clinical trials. Lectures will focus on the practical aspects of study set-up activities (i.e., study planning issues, data collection strategies, selecting investigators), student conduct activities (i.e., recruitment issues and enrollment strategies, obtaining informed consent, monitoring both patient and safety data quality and integrity and conducting site visits for study initiation, periodic monitoring and multiple site closings), and study termination activities. The course also covers responsibilities of sponsors, clinical monitors, clinical research organizations, investigators and institutional review boards. In-class activities will allow students to gain a greater appreciation of operational issues associated with various clinical research-related regulatory documents by working with case studies related to the content studied. Lectures are based on U.S. regulations and guidelines, as well as international good clinical practices and significant clinical research-related documents.

Lecture Spring. Prerequisite(s): CLNR 363 and CLNR 364