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Apr 28, 2024
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MEDDV 120 - Fundamentals of Clinical Trials
3.0 Credits
Overview of clinical research essentials focusing on ethical, regulatory and legal issues; epidemiology; and overall planning process of clinical trials regulated by the FDA. Provides tools to monitor data management and aid clinical investigations.
Course Objectives
Upon successful completion of this course, students will be able to:
- Identify the differences between requirements of device and pharmaceutical trials as defined by the FDA approval process. [REASON]
- Identify and explain the stages of development in the device arena from pre-clinical to post marketing. [REASON]
- Identify required elements in a clinical protocol. [REASON]
- Recognize and describe adverse events and FDA reporting requirements. [REASON]
- Explain the basic concepts of medical device clinical trials and describe the responsibilities of each member of the clinical team. [EXPLORE]
- Describe the ethical considerations and documents available that govern Good Clinical Practices in a clinical trial. [ACT]
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