This course provides the basic concepts of what clinical research is, how it is carried out and by whom, and its underlying ethical and regulatory framework. It discusses the key principles of Good Clinical Practice such as data management and the protection of human subjects. It further explores specific issues in clinical research, including protocol design, critical regulations and oversight bodies, common types of clinical trials, regulatory compliance, and clinical research billing.
Note: The course provides an overview of the clinical research enterprise and its parts. It is meant to supplement (not replace) Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses.
Language Availability: English
Suggested Audiences: Clinical Billing Professionals, Clinical Data Managers, Clinical Research Coordinators (CRCs), Compliance Officers, Contract Research Organizations (CROs), Faculty and Post-Docs, IRB Administrators, IRB Members, Legal and Risk Management Staff, 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