Global Clinical Trials Playbook: Capacity and Capability Building (Hardcover)

Section 1: Clinical Trials 1. Introduction 2. Global Clinical Trials: Study Design and Planning 3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials: African Perspectives 4. Clinical Trial Sites Capabilities: Standard Operating Procedure Implementation in Effective African Models 5. How to Select and Oversee Contract Research Organizations 6. The How-To of Global Clinical Trial Forecasting, Budgeting and Project Management

Section 2: Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets

7. Lessons Learned in India 8. Lessons Learned in China 9. Lessons Learned in Eastern Europe 10. Lessons Learned in Singapore 11. Lessons Learned in Turkey

Section 3: Regulatory Capacity 12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan’s Experience as an Example

Section 4: How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability 13. Pharmacovigilance and Risk Management

Section 5: Electronic Data Capture 14. Setting up Electronic Data Capture Capabilities

Section 6: Ethics, Human Resources, and Intellectual Property 15. Ethics and International Review Board Capacity Building

Section 7: Quality Assurance and Data Management 16. Clinical Quality Assurance and Data Management

Appendix A - Sample Protocol Template Appendix B - Sample Informed Consent Form Appendix C - Sample Case Report Form Appendix D - Sample Statistical Analysis Plan Appendix E - Case Report Form Versioning Policy Appendix F - Checklist for Study Close-out Appendix G - Financial Disclosure Form