CLINICAL TRIAL APPLICATIONS IN CANADA

Main Article Content

Agnes V Klein
Anne M Tomalin

Keywords

Regulations, clinical trials, Health Canada

Abstract

Clinical trials in Canada in Phases I to III or for a new indication in Phase IV are required to conform to specific regulations that are monitored by Health Canada. These regulations apply to manufacturers and independent researchers. The process involves a Clinical Trials application, required practices that are performed during and after the clinical trial and inspection activities

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