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

From Health Canada

Current status: Closed

Between December 15th, 2017 and April 15th, 2018 Health Canada is seeking input from Canadians and key stakeholders on the draft of GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”.

Why

Health Canada is looking for your input on the draft guidance for GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects. This guide is designed to make Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” easier to understand. It is intended to:

• promote stakeholder compliance with Part C, Division 5
• promote consistency and quality in the conduct of Health Canada compliance activities
• provide interpretation of Part C, Division 5, and specifically in terms of its relationship to ICH E6(R2)

Sponsors must ensure that their clinical trials are in compliance with regulatory requirements and good clinical practices. Sponsors who test drugs on human subjects (under Part C, Division 5 of the Food and Drug Regulations) must use good clinical practices to ensure that subjects’ rights, safety, and well-being are protected. Sponsors must also ensure that the data generated from a trial are reliable and accurate, so that they can be used to support the approval of a drug, or inform current clinical standards of practice with respect to the use of certain medications.

Who

We are seeking comments from:

• Clinical trial stakeholders, such as:
  • Sponsors
  • Qualified investigators (QIs)
  • Contract research organizations (CROs)
  • Site management organizations (SMOs)
  • Academia and researchers
• Clinical trial subjects and related patient groups
• The general public

What

Health Canada is looking for comments on:

• The clarity and expectations on how to comply with Part C, Division 5, including the interpretation of ICH E6(R2) in the Canadian context

Health Canada is not looking for comments on:

• The wording or specific provisions of Part C, Division 5 of the Food and Drug Regulations
• The wording and provisions of ICH E6(R2)

When and where

Feedback will be collected between December 15th, 2017 and April 15th, 2018.

Health Canada is partnering with several organizations for this consultation. Please see below on how to participate.

How to participate

There are 3 ways to participate:

1. If you, or your employer, are a member of any of the following organizations, you may choose to provide your feedback to these organizations so that they can provide a consolidated response to Health Canada, representative of the views of their members. You may contact the individual organizations to learn more about their engagement approach with their members on this consultation:
   
   
   • N2 – Network of Networks
     n2canada.ca/
     Contacts:  Karen Arts, karen.arts@oicr.on.ca, 416-673-6637
                     Susannna Sellman, Susanna.Sellmann@uhnresearch.ca, 416-946-4501 x3221
     
     N2 Member Organizations: n2canada.ca/members/
     
     
   • CCCTG – Canadian Critical Care Trials Group
     www.ccctg.ca/
     Contact:  Nicolay Ferrari, nicolay.ferrari.chum@ssss.gouv.qc.ca, 514-890-8000 x30833

   • CellCAN – Regenerative Medicine and Cell Therapy Network
     www.cellcan.com
     Contact:  Craig Hasilo, c.hasilo@cellcan.com, 514-252-3400 x4137

      

2. If you are a patient who is interested in clinical trials, you may send your comments directly to Health Canada (see #3), or contact one of the organizations or their member organizations below, who will be holding a patient focus group, to solicit feedback. For more information, please contact:

   • Colorectal Cancer Canada
     www.colorectalcancercanada.com/
     
     Contact:  Filomena Servidio-Italiano, filomenas@colorectalcancercanada.com, 1-877-502-6566 x2632

   • Health Charities Coalition of Canada
     www.healthcharities.ca/
     Contact:  Connie Côté, ccote@healthcharities.ca, 613-440-4411

     Health Charities Coalition of Canada Member Organizations:
     www.healthcharities.ca/membership/our-members.aspx

      

3. For all other interested parties, please contact Health Canada to obtain a copy of the consultation document and Comment Form at the following coordinates
   • email at: GCP_BPC@hc-sc.gc.ca
                   Please include “GUI-0100 Consultation” in the subject line
   • fax at:    613-960-2156
   • post at: Clinical Trial Compliance Program
                  Rm 1455C, 14th Floor, Jeanne Mance Building
                  200 Eglantine Driveway
                  Address Locator 1914C
                  Ottawa, ON K1A 0K9        

Related information

• Food and Drugs Regulations, Part C, Division 5 “Drugs for Clinical Trials Involving Human Subjects”
• Notice – Interim Implementation of International Council for Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice, ICH Harmonized Tripartite Guideline, Topic E6(R2)
• The draft content of GUI-0100 has taken into consideration:
  • Recommendations from  the Initiative to Streamline Clinical Trials (ISCT) – Guidance for Investigator-Sponsors (February, 2014), which address issues raised by the academic/non-commercial research community
  • The contents of Guidance for Records Related to Clinical Trials (GUIDE-0068, May 2006) published by Health Canada. This guidance document will be replaced by the consultation guidance document (GUI-0100)
  • Frequently asked questions, posed by stakeholders, to Health Canada’s Clinical Trial Compliance Program over the years, seeking clarification on regulatory interpretation 

Contact us

Clinical Trial Compliance Program
14^th floor, 200 Eglantine Driveway
Address Locator 1914C
Ottawa, ON K1A 0K9

Telephone: 613-946-8844
Email: GCP_BPC@hc-sc.gc.ca