Therapeutic Products Directorate
Guidance for Industry E6 Good Clinical Practice (GCP): Consolidated Guidance document (as adopted by Health Canada)
GCP Origins **
GCP Compliance Part 1 **
GCP Compliance Part 2 **
Inspection Planning **
GCP Pre-Inspection (Questions and Checklist)
Guidance for Records Related to Clinical Trials
Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)
Summary Report of Inspections of Clinical Trials Conducted from April 2004 to March 2011
Current Health Canada Audit Info (Local Educational Event 2011)
Clinical Trials and Safety Surveillance of Drugs in Development
Medical Devices
Biologics, Radiopharmaceuticals and Genetic Therapies
Regulatory Directive: Good Laboratory Practice
Good Manufacturing Practices (GMP) Guidelines- 2009 Edition (GUI-0001)
**Health Canada has provided permission to use the slides from the GCP Information session held in November 2010. Note that permission to use the slides includes a reminder that they represent Health Canada's current position at the time, do not constitute legislation, and are from November 2010.