Practical Guide to Clinical Data Management - Tapa dura

Prokscha, Susanne

 
9780849376153: Practical Guide to Clinical Data Management
Tapa dura
ISBN 10: 0849376157 ISBN 13: 9780849376153
Editorial: CRC Press, 2006

Sinopsis

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.

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

    Reseña del editor

    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.

    • Reseña del editor

    Examining the role of data management in clinical trials, "Practical Guide to Clinical Data Management, Second Edition" provides a solid introduction to the key process elements of clinical data management. It incorporates the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures. This edition examines the differences in data management between EDC-based studies and paper-based studies.

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

    Editorial
    CRC Press
    Año de publicación
    2006
    Idioma
    Inglés
    ISBN 10 
    0849376157
    ISBN 13 
    9780849376153
    Encuadernación
    Tapa dura
    Número de edición
    2
    Número de páginas
    252
    Contacto del fabricante
    no disponible
    Persona responsable
    no disponible