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RAS 631. IDE Regulations and Clinical Trial Design

Credits: 4
Department: Regulatory Affairs
Description: Conducting clinical research on unapproved medical devices. Pre and post market approval requirements and logistics of conducting clinical trials. Principles of clinical trial design. Common study designs and scientific and practical advantages and disadvantages. Clinical Trial Life Cycle.
Prerequisites: RAS 621
Semester Offered: DEMAND
Grading Method: ABCDF







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