This topic is designed to provide a framework for understanding the standards and regulations related to the clinical research  functions. The course will start 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, and GCP. Additionally, safety related topics as the Tri-Council Policy Statement, the Food and Drugs Act, SAP program and privacy legislation will be discussed.