Relevant Links
Food and Drugs Act and Regulations
Links to sections of the Regulations relevant to the conduct of clinical trials (Part C, Division 5 of the Regulations: Drugs for Clinical Trials Involving Human Subjects):
- C.05.001 - Interpretation
- C.05.002 - Application
- C.05.003 - Prohibition
- C.05.004 - General
- C.05.005 - Application for Authorization
- C.05.006 - Authorization
- C.05.007 - Notification
- C.05.008 - Amendment
- C.05.009 - Additional Information and Samples
- C.05.010 - Sponsor's Obligations - Good Clinical Practice
- C.05.011 - Sponsor's Obligations - Labelling
- C.05.012 - Sponsor's Obligations - Records
- C.05.013 - Sponsors' Obligations - Submission of Information and Samples
- C.05.014 - Sponsor's Obligations - Serious Unexpected Adverse Drug Reaction Reporting
- C.05.015 - Sponsor's Obligations - Discontinuance of a Clinical Trial
- C.05.016 - Suspension and Cancellation
Guidance documents
Guidance Documents - Clinical Trial Applications:
- Guidance for Clinical Trial Sponsors: Clinical Trial Applications
- Draft Guidance for Industry: Clinical Trial Applications for Comparative Bioavailability Studies for Pharmaceuticals
Quality Guidance Document for Pharmaceuticals:
Quality Guidance Documents for Biologics:
Guidance Documents - Positron Emitting Radiopharmaceuticals:
Guidance Document - Pharmacogenomic Information:
Health Canada / ICH Guidance Documents:
- E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- E6: Good Clinical Practice: Consolidated Guideline
- E8: General Considerations for Clinical Trials
- E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Additional Health Canada / ICH Guidance Documents are also available on Health Canada's Drugs and Health Products website.
Other:
- Inspection Strategy for Clinical Trials
Forms and Templates
Forms:
Templates:
- Protocol Safety and Efficacy Assessment Template - Clinical Trial Application (PSEAT-CTA)
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase I) (QOS-CE (CTA - Phase I))
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase II) (QOS-CE (CTA - Phase II))
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase III) (QOS-CE (CTA - Phase III))
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Bioavailability Studies) (QOS-CE (CTA - BA))
Instructions for Completing Forms/Templates
Useful Internet Websites
Page details
- Date modified: