Consultation on the Risk classification guide of observations related to clinical trial inspections of human drugs (GUI-0043)

From Health Canada

Health Canada is seeking comments from Canadians and key stakeholders on the updated version (draft) of GUI-0043: Guidance Document – “Risk classification guide of observations related to clinical trial inspections of human drugs”.

Regulated parties that are involved in the conduct of clinical trials of drugs in humans must comply with the Food and Drugs Act (the Act) and Part C, Division 5 “Drugs for Clinical Trials Involving Human Subjects” of the Food and Drug Regulations (the Regulations).

The Clinical Trial Compliance Program (CTCP) of Health Canada’s Regulatory Operations and Enforcement Branch (ROEB), inspects regulated parties for compliance with the Act and the Regulations. This guide is intended to:

• Promote consistency in the assignment of risk ratings of inspection observations and in the overall inspection rating.
• Provide examples of inspection observations and describe how inspectors classify clinical trial inspection observations based on risk.
• Describe how the overall rating is assigned to an inspection, when applicable, and includes situations that may result in a non-compliance (NC) rating.

Join in: how to participate

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

There are 2 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. They will then provide a consolidated response on the views of their members to our Health Canada representative. You may contact the individual organizations to learn more about their member engagement approach on this consultation:
   
   
   • N2 – Network of Networks
     n2canada.ca/
     Contact: Jennifer Li
     Jennifer.Li@uhn.ca, 416-319-6271
     N2 Member Organizations: n2canada.ca/members/
     
   • SOCRA – Society of Clinical Research Associates
     https://www.socra.org/
     Contact: Jennifer Li
     Jennifer.Li@uhn.ca, 416-319-6271
     SOCRA Member Organizations: https://www.socra.org/membership/
     
2. For all other interested parties, please contact by email Health Canada to obtain a copy of the consultation document and Comment Form.
   Email: GCP_BPC@hc-sc.gc.ca  

Who is the focus of this consultation

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
• Any affected parties including the general public

What happens after the consultation

The input gathered throughout this consultation will be analyzed and considered in finalizing the guidance document. The updated version of GUI-0043 will be published on the Health Canada website.

Related information

• Food and Drug Regulations
• GUI-0100: Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”
• International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2)

Contact us

Clinical Trial Compliance Program
Medical Devices and Clinical Compliance Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Email: GCP_BPC@hc-sc.gc.ca