ICH and Legislation Governing Clinical Research

Course Code

CLIN 5210

Academic Year

2016-2017

This course is designed to provide a framework for understanding the standards and regulations that affect the conduct of clinical trials. The course will starts with a historical overview of such documents as the Nuremberg Code, the Belmont Report and The Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, which will include GCP, reporting of adverse reactions and trials in special populations. Additionally, such topics as the Tri-Council Policy Statement and , the Food and Drugs Act with pertaining regulations will be discussed.