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

Synopsis

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.

A propos du livre

À propos de l?auteur

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.

Détails de l'édition

• Éditeur: CRC Press
• Date d'édition: 2017
• Langue: anglais
• ISBN 10: 1138196509
• ISBN 13: 9781138196506
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 255
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible