Regulatory and Compliance Issues

GMS BT 540

Clinical research is conducted to meet the needs of the intended patient population with an investigational medical intervention. But a favorable medical outcome is not the only criterion that is used to judge whether a product can be marketed. Clinical research needs to meet the rigorous standards of the regulators, the ethicists, and the auditors. This course reviews the laws that are in place that are designed to guide the complexities of clinical research. We will use case studies to illustrate what can really happen when clinical studies are conducted -- you may be surprised with what you find. Using group activities and exercises, we will explore the options and approaches used to manage these clinical research issues. 4 cr.

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