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- biol-537 - clinical-trials-project-management-setting-up-clinical-trials
California State University-Fullerton Course Info
Fullerton, California
Course Info
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BIOL 537
Clinical Trials Project Management: Setting Up Clinical Trials
Comprehensive overview covers implementation of Good Clinical Practices (GCP), documentation, Institutional Review Board (IRB) requirements, qualification of study sites, insurance requirements, statistical considerations in study design, ethical issues and global considerations. Team projects based on case studies/ real world examples
Units: 3.0
Prerequisites:
BIOL 576 - Regulatory Affairs for the Biotechnology Industry