Aspects of Regulatory History

Regulatory standards for conducting clinical trials are in place to protect those conducting and participating in clinical trials. This course describes the regulatory requirements of the US Department of Health and Human Services (HHS), Food and Drug Administration (FDA), and the guidelines of the International Conference on Harmonisation (ICH) necessary to ensure proper and successful clinical trial execution. Topics in this course include: History, Organizations, Regulations, and Guidelines. After completing this course, learners will be able to recognize the impact of ICH guidelines on the industry from a global perspective.

Recognize the historical events that brought about the regulatory requirements for conducting clinical trials. Identify the standards, organizations, regulations, and guidelines that are involved when conducting clinical trials.