A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Chapter 1: Rules, Roles and Responsibilities Chapter 2: Products, Protocols, and Pre-trial Preparation Chapter 3: Sponsor, Site and Study Start-up Chapter 4: Enticement, Enrollment, and Engagement: The Informed Consent Process Chapter 5: From Enrollment to Final Visit Chapter 6: Collaborating for Compliance and Quality Data - Monitoring and Audits Chapter 7: Building Budgets Chapter 8: Contracts, Clauses and Closing the Deal Chapter 9: US Clinical Trials - Additional Topics Chapter 10: Clinical Research and India