A Practical Guide to Managing Clinical Trials - Couverture rigide

Pfeiffer, JoAnn; Wells, Cris

Couverture rigide

ISBN 10 : 1138196509 ISBN 13 : 9781138196506

Editeur : CRC Press, 2017

A propos du livre

Biographie de l'auteur

Dr. JoAnn Pfeiffer is the Associate Director and a Faculty Associate in the Clinical Research Program at Arizona State University. Additionally she has taught global regulatory affairs and research management courses for George Washington University and Thomas Edison State College. She earned both a Doctorate and Masters in Regulatory Science from the University of Southern California and also holds a Masters and Bachelors’ of Science in Community Health from the University of Utah. Her experience includes directing clinical trials in both academic and nonacademic environments, responsible for day-to-day operations, site compliance, regulatory submission, data and document management and control, training of study staff. In her various roles in research and as a compliance officer/product manager she was responsible for ensuring compliance with the FDA Code of Federal Regulations, good clinical practices, industry guidance and best practices for clinical trials, electronic records, and clinical trial management software. Dr. Pfeiffer presents nationally and internationally at professional meetings, has authored articles in scientific journals, and is a published author.

Professor Cris Wells is a Clinical Professor and Director of Clinical Research Management Programs at Arizona State University within the College of Nursing and Health Innovation’s master’s degree programs. A radiologic technologist and electrical engineer by training, Professor Wells has a long history of overseeing health care and research projects in basic, translational, and clinical research. Prior to joining ASU, she was Director of Clinical Research Programs at Gateway Community College of Maricopa County for six years, Director of Clinical Operations at TD2 (a division of the Translational Genomics Research Institute (TGen)) for three years, Director of the Western Regional Community Clinical Oncology Program and oncology research at Banner Health for seven years, and Supervisor of Neurobiology research at Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center for two years. Her engineering background centered on pacemaker design when working for Medtronic. She also served as the consumer representative on the Food and Drug Administration Medical Device Advisory Panel for four years. Professor Wells’ current interests are focused on workforce development and curriculum design of emerging research and health care professions, including biorepository administration and health care compliance.

Présentation de l'éditeur

This book is a practical guide for researchers, study staff and students on proper and compliant conduct of clinical trials. It is intended to provide a user-friendly reference for day-to-day operations of industry-sponsored, FDA regulated studies. This practical guide takes the reader through each step of the process including site selection, site set-up, staff roles and responsibilities, training and qualifications, budget and contract review, negotiation and management, in-depth review of study visits, data management and documentation, trial reporting, audits and inspections. Each chapter concludes with a review of key points, short exercises to apply knowledge, and review questions.

Détails de l'édition

• Éditeur: CRC Press
• Date d'édition: 2017
• ISBN 10: 1138196509
• ISBN 13: 9781138196506
• Reliure: Relié
• Langue: anglais
• Numéro d'édition: 1
• Nombre de pages: 256