Clinical Research and Drug Development Process

This five-week course equips you with the knowledge needed 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). This course introduces the key terms and concepts of clinical research, and provides an introductory overview of the principles and practice of clinical research. Each week, the material will build upon the prior week. Students will analyze major historical events which outline the need for  global standards in the design and conduct of clinical trials throughout the world, understand 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.