Global Clinical Trials Playbook

<p>Section 1: Clinical Trials<br>1. Introduction<br>2. Global Clinical Trials: Study Design and Planning<br>3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials: African Perspectives<br>4. Clinical Trial Sites Capabilities: Standard Operating Procedure Implementation in Effective African Models<br>5. How to Select and Oversee Contract Research Organizations <br>6. The How-To of Global Clinical Trial Forecasting, Budgeting and Project Management</p> <p>Section 2: Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets</p> <p>7. Lessons Learned in India<br>8. Lessons Learned in China<br>9. Lessons Learned in Eastern Europe<br>10. Lessons Learned in Singapore<br>11. Lessons Learned in Turkey</p> <p>Section 3: Regulatory Capacity<br>12. Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan’s Experience as an Example</p> <p>Section 4: How to Build and Enhance Pharmacovigilance and Risk Management Capacity and Capability<br>13. Pharmacovigilance and Risk Management</p> <p>Section 5: Electronic Data Capture<br>14. Setting up Electronic Data Capture Capabilities</p> <p>Section 6: Ethics, Human Resources, and Intellectual Property<br>15. Ethics and International Review Board Capacity Building</p> <p>Section 7: Quality Assurance and Data Management<br>16. Clinical Quality Assurance and Data Management </p> <p>Appendix A - Sample Protocol Template<br>Appendix B - Sample Informed Consent Form<br>Appendix C - Sample Case Report Form<br>Appendix D - Sample Statistical Analysis Plan<br>Appendix E - Case Report Form Versioning Policy<br>Appendix F - Checklist for Study Close-out<br>Appendix G - Financial Disclosure Form</p>