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Human Subjects Safety in Clinical Trials

A required course in the Certificate Program in Clinical Trials: Medical Device and Drug Development.

Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.×

Course Description

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.

Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 15 contact hours.

  • Be notified when this class becomes available!

  • Details
  • $550
  • January 17, 2022 to March 06, 2022
  • Delivery Mode: Online
  • Reg#: 00157
  • ID/Units: BME X430  (2.00)
    ( Section 1 )
  • Quarter: WINTER 2022


Catherine A. Kusnick, MD is a UCI medical school graduate and Principal, Headlands Consulting. She has headed clinical departments at medical device start-ups for 8 years after 2 years in pharma. She currently consults with device start-up companies. Her strategic and tactical experience includes study conduct, project management, data analysis, Medical Affairs, writing Regulatory submissions. While practicing medicine, she taught at two medical schools, served as a Study Investigator and published/lectured extensively.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START01/17/2022Monday------Online (Access Begins)---
END03/06/2022Sunday------Online (Access Ends)---