Research Compliance

Announcements

Health Canada - Notice: Period reduced for keeping clinical trial records for drugs and natural health products – March 2, 2022

Health Canada – Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations (Interim Order No. 2 repealed) – March 2, 2022

Research Compliance is responsible for the delivery of quality regulatory guidance for clinical research conducted at Island Health through the adherence to local, national, and international regulations, guidance, and policies. 

Compliance is a process of important administrative steps to demonstrate that your research – and by extension, Island Health – is compliant with the requirements of the funding agency and law, and they apply to all research conducted at Island Health and its sites. If your research does not comply with regulations, it will not be supported and may put future funding at risk. 

Services
  • Regulatory Compliance Consults
    • Supporting questions about regulations, policies, guidance and their application to clinical research
    • United States Public Health Service Financial Conflict of Interest Regulations (PHS FCOI Regulations) 

 

  • Regulatory Training for Individuals and Groups
    • Used to demonstrate compliance with the regulatory requirements for education in respective topics
    • Building a development plan for training based upon the research being conducted

 

  • Quality Assessments
    • Working with study teams to address ways to improve compliance to regulations, policies, and guidance.

 

  • Auditing
    • Assessing the conduct of a clinical trial against the study protocol, Good Clinical Practice (GCP), and applicable regulations policies and guidance.
Training

View Guidance for Research Training Requirements

  • Collaborative Institutional Training Initiative (CITI)
    • Through Island Health’s partnership with N2, the following training is available through CITI for Island Health staff, physicians, contractors, and affiliates, free of charge, when affiliated with ‘Vancouver Island Health Authority’
      • Good Clinical Practice (GCP)
      • Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects
      • Responsible Conduct of Research (RCR)– Life Science
      • Transportation of Dangerous Goods (TDG)
      • The Biomedical Research Ethics Tutorial
      • Social and Behavioural Research course
Resources

Network of Networks (N2) Standard Operating Procedure Templates

  • Access to nationally developed and reviewed SOP templates for clinical research and Investigator Initiated studies.

  • For more information, Island Health Researchers and study team members can review Island Health's 'Policies & Procedures' Intranet page under 'Research' to learn how they can access these templates.

US Public Health Service Financial Conflict of Interest (FCOI) Regulations 

Partnerships

For more information on Research Compliance please contact us.