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.
Table of Contents
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
Dr. JoAnn Pfeiffer has extensive experience in site management, and is currently the Program Director of Arizona State University’s (ASU) Clinical Research Management Program in the College of Nursing and Health Innovation.
Dr. Cris Wells has broad experience in overseeing basic and translational studies as well as clinical trials. She is currently the Senior Director of Health-Related Programs at ASU.
'"A Practical Guide to Managing Clinical Trials" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing makes the book a quick read.'
– Norman M. Goldfarb for Journal of Clinical Research Best Practices, Vol. 13, No. 12, December 2017.