REGS 621 CLINICAL RESEARCH
Well-designed clinical research is essential in the development process of a medication or device and in generation of the knowledge base for evidence-based medicine and health policy. This online course is designed to uncover the ingredients of clinical research and to orient students of several important issues with current clinical studies. The students will learn how to design and implement different clinical studies. The role of each clinical phase in drug/device development and their various study designs and regulatory issues will be explored. The course will also discuss the Principles of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and how to successfully manage clinical trials. Additionally, knowledge of personalized medicine and behavioral/social issues in drug use will be taught.