IRB Review of Medical Devices
This six-part course offers a highly practical and informative look at Institutional Review Boards (IRBs), groups who analyze and review research to ensure that the rights and welfare of human research subjects are protected.
This course covers the following topics:
- Historical development, structure, and function of IRBs
- Ethical standards regarding IRBs
- A review of medical device research protocols and related materials
Upon successfully completing this course, learners will be able to:
- Comprehend the function and structure of an IRB
- Identify the role and responsibilities of an IRB in the review of medical device clinical studies
- Recognize the correlation between a device’s classification, market trajectory, and investigational status
Clinical research associates (monitors), senior clinical research associates, clinical project and compliance managers, clinical quality associates and managers, clinical affairs directors, regulatory affairs managers, clinical investigators, and clinical study coordinators and marketing and sales managers involved in clinical investigations are all encouraged to enroll in this course.
The following courses are required:
- Introduction to Good Clinical Practice (ID 42)
- Introduction to Medical Device and Clinical Investigation Planning (ID 43)
- The Informed Consent Process (ID 45)
- Ethics Committee (EC)/Institutional Review Board Requirements (ID 46)