Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - Summary

From Health Canada, Regulatory Operations and Enforcement Branch (ROEB)

Overview

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations) and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) in the Canadian context.

Guidance documents are administrative instruments not having force of law. Alternate approaches to the principles and practices described in this guidance document and ICH E6(R2) may be acceptable provided they are supported by adequate scientific justification.

This guidance document was developed by Health Canada in consultation with stakeholders.

Who this guide is for

This guidance document is for any parties involved in the conduct of clinical trials of drugs in human subjects in Canada, such as:

• Sponsors
• Qualified Investigators (QIs)
• Contract Research Organizations (CROs)
• Site Management Organizations (SMOs)

In this guide

1. About this document
   1. Purpose
   2. Scope
   3. Introduction
   4. Guidance for implementation
   5. Regulations and Interpretations
      • 5.1 Interpretation
        • C.05.001
      • 5.2 Application
        • C.05.002
      • 5.3 Prohibition
        • C.05.003
      • 5.4 General
        • C.05.004
      • 5.5 Application for Authorization
        • C.05.005
      • 5.6 Authorization
        • C.05.006
      • 5.7 Notification
        • C.05.007
      • 5.8 Amendment
        • C.05.008
      • 5.9 Additional Information and Samples
        • C.05.009
      • 5.10 Good Clinical Practices
        • C.05.010
        • C.05.010(a)
        • C.05.010(b)
        • C.05.010(c)
        • C.05.010(d)
        • C.05.010(e)
        • C.05.010(f)
        • C.05.010(g)
        • C.05.010(h)
        • C.05.010(i)
        • C.05.010(j)
      • 5.11 Labelling
        • C.05.011
      • 5.12 Records
        • C.05.012
      • 5.13 Submission of Information and Samples
        • C.05.013
      • 5.14 Serious Unexpected Adverse Drug Reaction Reporting
        • C.05.014
      • 5.15 Discontinuance of a Clinical Trial
        • C.05.015
      • 5.16 Suspension and Cancellation (Intent to Suspend)
        • C.05.016
      • 5.17 Suspension and Cancellation
        • C.05.017
   • Appendices
     • Appendix A – Glossary
       • Acronyms and abbreviations
       • Terms
     • Appendix B – References
       • Law and Regulations
       • Health Canada Guidances and Documents
       • Other Guidances and Policies

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Details and history

Published:

August 20, 2019

Updated:

New document

Consulted:

December 15, 2017 to April 15, 2018 (see the consultation)

Part of topic:

Interpretation of Part C, Division 5 of the Food and Drug Regulations

For assistance

Clinical Trial Compliance Program
Contact us by email: GCP_BPC@hc-sc.gc.ca