Contents

1. Introduction to Clinical Trials 2. What Is The Question? 3. Study Population 4. Basic Study Design 5. The Randomization Process 6. Blindness 7. Sample Size 8. Baseline Assessment 9. Recruitment of Study Participants 10. Data Collection and Quality Control 11. Assessing and Reporting Adverse Effects 12. Assessment of Health-Related Quality of Life 13. Participant Adherence 14. Survival Analysis 15. Monitoring Response Variables 16. Issues in Data Analysis 17. Closeout 18. Reporting and Interpreting of Results 19. Multicenter Trials