Clinical trials are reviewed by:

• Research experts
• Regulatory boards, such as Health Canada
• Scientific panels
• Research Ethics Board(s)
• Data Safety Monitoring Boards
• The Principal Investigator, and
• The clinical trials research team.

Everyone involved in a clinical trial must follow procedures and ethical standards to protect patient health, safety, and privacy.

Clinical trials are closely supervised, documented, and monitored by our Juravinski Cancer Centre Clinical Trials Department and by the following government and international policies:

• Tri-council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)
• Ontario Personal Health Information Protection Act (PHIPA 2004)
• Health Canada Food and Drug or Device Regulations
  • Part C Division 5 of the Food and Drug Regulation of Health Canada
  • Part 3 of the Medical Devices Regulation of Health Canada
• US Food and Drug Administration
• International Conference of Harmonization (ICH) Guidance E6:Good Clinical Practice (GCP) Consolidated Guidelines