Resources

Research Ethics

Belmont Report

Nuremburg Code

Declaration of Helsinki

Health Canada

Food and Drugs Act 

Food and Drug Regulations 

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

Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications

Clinical Trial Applications (CTAs)

Cannabis Act 

Cannabis Regulations

A Guide to Health Canada Inspections

The International Council For Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

ICH Harmonized Tripartite Guideline: General Considerations for Clinical Studies E8(R1)

ICH Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2)

ICH Harmonized Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials E10

ICH Harmonized Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials E17

ICH Harmonized Tripartite Guideline: Quality Risk Management Q9

Other

United States Code of Federal Regulations (CFR)

International Medical Device Regulators Forum (IMDRF)

International Organization for Standardization (ISO)    

International Pharmaceutical Regulators Programme (IPRP)

Pharmaceutical Inspection Co-Operation Scheme (PIC/S)

World Health Organization (WHO)