Clinical Research and Drug Development Process

This five-week course equips you with the knowledge to determine compliance with Good Clinical Practice (GCP) during the conduct of a clinical trial as regulated by the Food and Drug Administration (FDA), state and local laws, and the International Council on Harmonisation (ICH). You learn key terms and concepts of clinical research and get an overview of the principles and practice of clinical research. You analyze major historical events which necessitated global standards in the design and conduct of clinical trials throughout the world, apply ethical frameworks and relevant international standards that guide the conduct of clinical research to ensure the rights, safety and well-being of patients on a clinical trial, identify and describe stages of drug development including post-market surveillance, and analyze the state of drug development, the changing environment, and current challenges to developing drugs.