This spiral-bound, 5" x 7.5" book is a compilation of documents governing the conduct of clinical research in Canada. It includes such topics as:
• Good Clinical Practice
• Ethical conduct for the protection of human subjects
• Clinical safety data management
Who Uses this Book and How?
• Clinical Research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution
• Non-Canadian-company staff conducting research in Canada
What's the Price?
• 1-249 copies: $18.95 • 250-499 copies: $17.95
• 500-749 copies: $16.95 • 750+ copies: $15.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• Declaration of Helsinki
• Health Canada
- Guidance For Clinical Trial Sponsors: Clinical Trial Applications
- Division 5 Regulations and Regulatory Impact Analysis Statement (extract)
- Medical Devices Regulations, Part 3
- Natural Health Products Regulations, Part 4
- Post-Authorization Requirements
• Tri-Council Policy Statement 2, Extract, 2018 Revision: Ethical Conduct for Research Involving Humans
• ICH Guidelines, Canadian-adopted version
E6 Good Clinical Practice
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E8 General Considerations for Clinical Trials
• The Belmont Report (US National Commission for the Protection of Human Subjects)
• The Nuremberg Code
