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Book 11: 2023 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada

Book 11: 2023 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada

$ 18.95

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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