Drug Development Process

Ethics in Clinical Research

Good Clinical Practice

Data Management and Bio Statistics

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.

This topic is designed to orient students to the Drug Development Process, the clinical research, functions within the corporate and regulatory context from Canadian and international perspectives. Development of drugs is used as a model. 

This topic covers the ICHG-E6 regarding the international guidelines for conducting clinical research

This topic will provide an introduction to clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, methods required in the development of clinical research data analysis.