Course Code: CLRE 5001
Academic Year: 2024-2025
This course is designed to provide a framework for understanding the standards and regulations that govern clinical trials. Students study historical overview of ethics-related documents such as the Nuremberg Code, the Belmont Report and The Declaration of Helsinki. Ethical issues impacting clinical trials and their relation to creation of regulations are analyzed. A large part of the course is dedicated to the International Council for Harmonization (ICH) guidelines, which include GCP and reporting of adverse reactions, and others. An outline of all relevant ICH guidelines is provided. Students study local and international regulatory requirements pertaining to pharmaceutical products. Privacy legislation as applicable to clinical research is also covered. Additionally, the international differences among applications for clinical trial submissions is reviewed and discussed. Case studies are used to practice the application of guidelines and relevant regulations.