II.  Principles of ICH GCP

• Principles of ICH GCP
• Principle 1. - (Ethics)
• Principle 2. - (ICF)
• Principle 3. (IRB/IEC Review)
• Principle 4. - (Science)
• Principle 5. (Qualified individuals)
• Principle 6. (Quality)
• Principle 7. (proportionate risk)
• Principle 8. (Design)
• Principle 9. (Reliable results)
• Principle 10. (Roles & responsibilities)
• Principle 11. (IMP)