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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 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 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.
This topic is designed to outline the various stages of clinical research including activities as they relate to the monitoring of the clinical trial sites. The course will review the progress of a study from the monitor’s as well as a sponsor’s and investigator’s perspectives and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control and clinical safety measures that ensure the collection of adequate data in addition to ensuring the safety of trial subjects.
- Professor: Pr. Peivand Pirouzi