A clinical trials manual from the Duke Clinical Research Institute: lessons from a horse named Jim

This book is needed to provide a manual for investigators, research nurses, and study coordinators with minimal experience or who are new to clinical research. From the case of the horse named Jim that initiated some of the earliest regulatory measures it covers the historical framework of clinical research, regulation and safety, before explaining the established procedures and protocols, patient safety, Good Clinical Practice, definitions, rules and regulations, and management of data. It will be used as a curricular text by programs established to train students and staff in the field of clinical trials and discusses most aspects of clinical trials, including history, current regulations, and practical suggestions for site staff in the day-to-day operations. The primary focus of the book is on clinical drug trials in the U.S., but it also includes clinical investigations of medical devices and biologics. The chapters provide a framework for current regulations, responsibilities and practices. Protocol and statistical issues are reviewed and discussed and many examples of forms, pertinent regulations, practical steps to implement clinical trials, information on electronic data capture and institutional review boards are included. It covers clinical investigations of medical devices and biologics as well as clinical drug trials. The Duke Clinical Research Institute is highly regarded in both the teaching and conduct of clinical trials.

• ISBN: 978-1-4051-9515-7
• Editorial: Wiley-Blackwell
• Encuadernacion: Rústica
• Páginas: 432
• Fecha Publicación: 29/01/2010
• Nº Volúmenes: 1
• Idioma: Inglés