ACR628

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Regulatory Compliance and Research Ethics

Applied Education in MedTech IndustryGraduateCollege of Business, Engineering, and Technology

General Prerequisites Credits Goals Learning Outcomes Course Outline Dependencies

Course Outline

Good clinical practice (GCP). 25% Informed consent in human trials. 10% Ethical clinical study design and conduct. 25% Regulatory guidance documents. 10% Pre-Market Application (PMA) and New Drug Applications (NDA) submissions. 20% International clinical trials. 10%