1st Edition

A Practical Guide to Managing Clinical Trials

By JoAnn Pfeiffer, Cris Wells Copyright 2017
276 Pages 13 B/W Illustrations
by CRC Press

276 Pages 13 B/W Illustrations
by CRC Press

276 Pages 13 B/W Illustrations
by CRC Press

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... Read more

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

Biography

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.