• Therapeutic Products Directorate
• Guidance for Industry E6 Good Clinical Practice (GCP): Consolidated Guidance document (as adopted by Health Canada)
• GCP Origins (pdf) **
• GCP Compliance Part 1 (pdf) **
• GCP Compliance Part 2 (pdf) **
• Inspection Planning (pdf) **
• GCP Pre-Inspection (Questions and Checklist) (pdf)
• 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) (pdf)
• Clinical Trials and Safety Surveillance of Drugs in Development (pdf)
• 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.