This course prepares medically trained individuals to become new medical monitors and enhances the knowledge of current medical monitors. Medical monitors participate as team members in clinical trials and have a key role in U.S. Food and Drug Administration-regulated research of drugs and biologics. The course describes the advice and input that medical monitors provide to sites and sponsors. It details their role in working with investigators to assess adverse events under 21 CFR 312. It also reviews the role monitors play in safety reporting to regulatory agencies and Institutional Review Boards. Lastly, the course provides learners with an overview of drug safety and pharmacovigilance.
Note: The course provides foundational role-based training for clinical research professionals. The course covers information that expands beyond but is directly connected to Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses. Learners should have completed these basic courses prior to taking this course.
Language Availability: English
Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators, Contract Research Organizations (CROs), Drug Safety Officers, Faculty, Medical Monitors, Principal Investigators, Research Administrators, Researchers, Sponsors, Students
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person