Best Practice for Clinical Monitoring - Couverture rigide

Gerald Van Roey

Couverture rigide

ISBN 10 : 3862500012 ISBN 13 : 9783862500017

Editeur : PharmImage

Synopsis

Attractive, affordable and easy to use, this book provides a sign-posted map for beginners and experienced Clinical Monitors through the maze of clinical research. Written from a wealth of personal experience, this book provides a real-life insight into clinical studies and the specific role of the Clinical Monitor. Through real-life situations, linked to regulatory and industry standards, this book covers the complete life cycle of a clinical trial. You will find practical tips and best practices for each phase of the clinical study, from selecting the right investigator to preparing for and surviving an inspection. With integrated examples of actual documents you will come across in the field and valuable lessons learned, this book will enable you to perform your job as Clinical Monitor to the very best of your ability and according to today's standards. You will discover: - How to fit into the activities of the world of clinical research - The latest regulations and guidelines, what they mean for you, how to follow them and where to find further information - How to prepare and perform site visits and interact with site personnel - What Essential Documents are and how they should be handled - How to document your work correctly according to international standards - How to foresee and avoid pitfalls in your study -What you need to progress in your chosen career - And more...

A propos du livre

À propos de l'auteur

Gerald Van Roey MPhEd is the Training Manager of the European Center for Clinical Research Training (ECCRT). He has more than 10 years of experience as a clinical monitor and has performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development.

Détails de l'édition

• Éditeur: PharmImage
• Langue: anglais
• ISBN 10: 3862500012
• ISBN 13: 9783862500017
• Reliure: Cartonné
• Numéro d'édition: 1
• Nombre de pages: 144
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible