MRA 602 Human Subjects in Clinical Trials

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course is designed to give the student the fundamental knowledge in the protection of human subjects in a clinical trial. The course will emphasize federal, state, and local regulations in protecting the health and welfare of human subjects in a clinical trial. Proper documentation, HIPAA regulations, IRBs, international codes of conduct, Declaration of Helsinski, Informed Consent, adverse events CFRs, and all other pertinent documents and codes will be covered.

Course Information

• Syllabus
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