Design, Execution, and Management of Medical Device Clinical Trials

Lingua: inglese

Editore: Wiley Sep 2009, 2009

0470474262 / 9780470474266

Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH

Venditore con 5 stelle

Venditore AbeBooks dal 14 agosto 2006

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Descrizione dell’articolo da parte del venditore

Neuware - An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur 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 study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: - Qualification and selection of investigators - Study monitoring visits - Definitions and reporting procedures for adverse events - The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints - The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.…

Codice articolo 9780470474266

Titolo
Design, Execution, and Management of Medical Device Clinical Trials
Autore
Salah M Abdel-Aleem
Editore
Wiley Sep 2009
Anno di pubblicazione
2009
Condizione
Neu
Rilegatura
Buch
Lingua
inglese
ISBN 10
0470474262
ISBN 13
9780470474266
Peso dell'articolo
613 grammi
Dimensioni
240x161x21 mm

AHA-BUCH GmbH

Einbeck, Germania

Venditore con 5 stelle

Venditore AbeBooks dal 14 agosto 2006

Tariffe di spedizione da Germania a U.S.A.

ArticoloDa 7 a 10 giorni lavorativiDa 5 a 7 giorni lavorativi
Primo articoloEUR 35,00EUR 45,00
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Einbeck, Germania 37574

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