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Practical Guide to Clinical Data Management - Tapa dura

Prokscha, Susanne

 
9781574910438: Practical Guide to Clinical Data Management
Tapa dura
ISBN 10: 1574910434 ISBN 13: 9781574910438
Editorial: CRC Press, 1999

Sinopsis

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications.

With the tools this book provides, you'll learn how to:

  • Ensure that your DMB system is in compliance with federal regulations
  • Build a strategic data management and databsing plan
  • Track and record CRFs
  • Deal with problem data, adverse event data, and legacy data
  • Manage and store lab data
  • Identify and manage discrepancies
  • Ensure quality control over reports
  • Choose a CDM system that is right for your company
  • Create and implement a system validation plan and process
  • Set up and enforce data collection standards
  • Develop test plans and change control systems

    This book is your guide to finding the most successful and practical options for effective clinical data management.

    • "Sinopsis" puede pertenecer a otra edición de este libro.

    Reseña del editor

    Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications.

    With the tools this book provides, you'll learn how to:

  • Ensure that your DMB system is in compliance with federal regulations
  • Build a strategic data management and databsing plan
  • Track and record CRFs
  • Deal with problem data, adverse event data, and legacy data
  • Manage and store lab data
  • Identify and manage discrepancies
  • Ensure quality control over reports
  • Choose a CDM system that is right for your company
  • Create and implement a system validation plan and process
  • Set up and enforce data collection standards
  • Develop test plans and change control systems

    This book is your guide to finding the most successful and practical options for effective clinical data management.

    • "Sobre este título" puede pertenecer a otra edición de este libro.

    Editorial
    CRC Press
    Año de publicación
    1999
    Idioma
    Inglés
    ISBN 10 
    1574910434
    ISBN 13 
    9781574910438
    Encuadernación
    Tapa dura
    Número de edición
    1
    Número de páginas
    296
    Contacto del fabricante
    no disponible
    Persona responsable
    no disponible