Practical Guide to Clinical Data Management - Couverture rigide

Prokscha, Susanne

 
9780849376153: Practical Guide to Clinical Data Management
Couverture rigide
ISBN 10 : 0849376157 ISBN 13 : 9780849376153
Editeur : CRC Press Inc, 2006

Synopsis

The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.

Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling.

Updates to the Second Edition include -

  • A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures
  • Practices for both electronic data capture (EDC)-based and paper-based studies
  • A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations

    The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task.

    Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

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

    Présentation de l'éditeur

    The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.

    Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling.

    Updates to the Second Edition include -

  • A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures
  • Practices for both electronic data capture (EDC)-based and paper-based studies
  • A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations

    The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task.

    Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

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

    Éditeur
    CRC Press Inc
    Date d'édition
    2006
    Langue
    anglais
    ISBN 10 
    0849376157
    ISBN 13 
    9780849376153
    Reliure
    Relié
    Numéro d'édition
    2
    Nombre de pages
    238
    Coordonnées du fabricant
    non disponible
    Personne responsable
    non disponible