Design, execution, and management of medical device clinical trials

Throughout this book, practical examples compiled from the author's previous clinical trial experiences are discussed in a sequential manner as they occurred in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical report study. This approach allows readers to have an integrated picture of every aspect of the clinical trial. In addition, the role of every member of the clinical research team, including all responsibilities associated with their function, is outlined. This book provides professionals with both an in-depth and broad range of knowledge of clinical research tasks and activities and allows readers to execute these tasks and activities successfully. Chapter coverage includes an overview of clinical study tasks and activities; development of the clinical protocol and other clinical materials, qualification and selection of investigators and study monitoring visits; adverse events definitions and reporting procedures; Statistical Analysis Plan (SAP) and biostatisticsin clinical research; final clinical study report; medical device regulations; design issues in medical device studies; investigator initiated clinical studies; and ethical conduct for human research.

• ISBN: 978-0-470-47426-6
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 288
• Fecha Publicación: 11/09/2009
• Nº Volúmenes: 1
• Idioma: Inglés