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May 05, 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-level Learning Objectives (CLOs)
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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