Articles liés à Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management - Couverture rigide

Prokscha, Susanne

 
9781574910438: Practical Guide to Clinical Data Management
Couverture rigide
ISBN 10 : 1574910434 ISBN 13 : 9781574910438
Editeur : Interpharm Press Inc, 1999

Synopsis

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.

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

    Présentation de l'éditeur

    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.

    • Biographie de l'auteur

    Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.

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

    Éditeur
    Interpharm Press Inc
    Date d'édition
    1999
    Langue
    anglais
    ISBN 10 
    1574910434
    ISBN 13 
    9781574910438
    Reliure
    Relié
    Nombre de pages
    296
    Coordonnées du fabricant
    non disponible
    Personne responsable
    non disponible