Clinical Trial Management

Catalog description

This course will focus on the practical aspects of executing clinical trials in an academic environment in a GCP compliant fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies. This course is divided into three segments. In the first segment, students will be guided through the operational aspects and regulatory processes of clinical trial management across the clinical trial life style from pre-study activities through study start-up and implementation, and ongoing compliance through study close out. Students will learn strategies for navigating the complex regulatory/operational clinical research environment and for successful protocol development and approval, subject recruitment, data management and IRB/FDA interactions. In the second segment of the course, students will learn about specific trial management challenges that may arise based on study type and will learn skills for navigating these challenges for investigator-initiated studies, federally-funded and commercially-sponsored research and research with unique trial management concerns such as conflicts of interest and the use of new technologies. Finally students will have the opportunity to apply the skills they have learned through a final course project which includes identification of a trial management challenge and a proposal for solutions to address that challenge. Protection of human research subjects and adherence to good clinical practices guiding research in humans is a critical concept that will be integrated throughout each of the lectures and course assignments.