BME X430
Human Subjects Safety in Clinical Trials
The use of human subjects in clinical trials for drug and device development requires sound ethical practices. Explore topics that include FDA regulations and guidance, informed consent process, the make-up and function of Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics. Course topics are enhanced by case studies, small group discussions, and research document reviews.
Course
Approximate Cost
TBD
Format
Online
Duration
TBD
Total Credits
2