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Application of Good Clinical Practices
A required course in the Certificate Program in Clinical Trials: Medical Device and Drug Development, and an elective course in Medical Product 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.
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Course Description
Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research engagement; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.
Prerequisite: BIOSCI X450, Fundamentals of Clinical Trials, or equivalent experience. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 30 contact hours.
Instructor
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
Event Date Day Start Time End Time Location Room
START 04/04/2022 Monday --- --- Online (Access Begins) ---
END 06/12/2022 Sunday --- --- Online (Access Ends) ---