CTM-540 Ethical Issues and Regulatory Principles in Clinical Trials
The purpose of this course is to gain a better understanding of the ethical issues and regulatory principles in clinical research. Each module has been designed to be a step-wise approach to understanding clinical research and how today's regulations impact tomorrow's drugs. Modules 1 through 3 take students through the basics of regulation. Module 1 discusses the basics of the Food and Drug Administration (FDA) by exploring the FDA's structure, history, and goals. Module 2 is an introduction to basic guidelines used when conducting clinical trials. Module 3 talks about the primary applications that must be submitted to the FDA for drug approval. All 10 modules discuss ethics in clinical research. Module 4 digs deeper into the realm of ethics by exploring early ethical guidelines, such as the Nuremberg Code and the Declaration of Helsinki. Module 5 then applies these guidelines to current practice. Modules 6 through 8 take the time to explore essential regulatory documents, regulatory inspections, and adverse event and safety monitoring, all essential aspects of running clinical trials. Finally, Modules 9 and 10 explore regulatory guidelines outside of the United States by discussing the basic regulatory guidelines in 21 other countries around the world. Each module has exercises designed to further enhance the student's drug development knowledge through reading, discussion boards, and assignments.