- Division 5 of the Food and Drug Regulations - Clinical Trials (PDF1)
Division 5 of the Food and Drug Regulations - Clinical Trials (PDF2) - Canadian Institutes of Health Research -
(PIPEDA Questions and Answers for Health Researchers) - The Health Products and Food Branch
- Health Canada, Food and Drug Regulations, Part C (Drugs), Division 5:
- This is the key legal document for inspections conducted by Health Products and Food Branch Inspectorate, The link will bring you to a pdf format document that includes all 9 divisions of Part C; the Division we are interested in is Division 5 (Drugs for Clinical Trials involving Human Subjects) and it is contained within pages 94 to 103. - Health Products and Food Branch, Guidance for Clinical Trial Sponsors: Clinical Trial Applications:
- This is a guidance document that outlines requirements for sponsors wishing to conduct clinical trials with drugs in human in Canada. The link will give you access to the complete (43 pages) guidance document, effective 25 Jun2003. - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans:
- This document (93 pages) describes standards and procedures for governing research involving human subjects in Canada. Sections 1 (Ethics Review), 2 (Free and Informed Consent), 3 (Privacy and Confidentiality) and 4 (Conflict of Interest) might be of special interest. - Here is a link for you to access the Policy Statement (amended in 2005)