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

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

$ 15.95

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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:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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, 2010 Revision: Ethical Conduct for Research Involving Humans (Revised to December 2014)

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

Click here to see an enlarged pdf cover