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]