Articles liés à The Fundamentals of Clinical Research: A Universal...

The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice - Couverture rigide

Dubinsky, P. Michael; Henry, Karen A.

 
9781118949597: The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice
Couverture rigide
ISBN 10 : 1118949595 ISBN 13 : 9781118949597
Editeur : John Wiley & Sons Inc, 2022

Synopsis

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations.

  • Describes the design of quality into the clinical trial planning
  • Has end-of-chapter questions and answers to check learning and comprehension
  • Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters
  • Offers a companion website containing supplemental training resources

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l'auteur

P. Michael Dubinsky has more than forty years of experience in the field of GxP quality and compliance in government and industry. He has worked with the FDA and as a regulatory consultant for private corporations. He was also an Instructor in the areas of clinical trial compliance, regulatory audits, and quality at the University of California Berkeley Extension Programs.

Karen A. Henry has worked as a clinical research professional since 1990. She has expertise in regulatory medical writing, standards and processes, trial management and monitoring, biostatistics, and data management. She is also a Lead Instructor for the Certificate Program in Clinical Research Conduct Management at the University of California Berkeley Extension Programs.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
John Wiley & Sons Inc
Date d'édition
2022
Langue
anglais
ISBN 10 
1118949595
ISBN 13 
9781118949597
Reliure
Relié
Nombre de pages
544
Coordonnées du fabricant
non disponible
Personne responsable
non disponible