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Health Canada/Good Clinical Practice (GCP)

  • 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.


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