Practical Guide to Clinical Data Management - Tapa blanda

Prokscha, Susanne

 
9781032498232: Practical Guide to Clinical Data Management
Tapa blanda
ISBN 10: 1032498234 ISBN 13: 9781032498232
Editorial: CRC Press, 2025

Sinopsis

The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers.

Features:

  • Provides an introduction and background information for the spectrum of clinical data management tasks.
  • Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam.
  • Explains the high-level flow of a clinical trial from creation of the protocol through study lock.
  • Reflects electronic data capture and interactive response technologies.
  • Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

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

Acerca del autor

Susanne Prokscha has been involved in clinical data management (CDM) processes and technologies since the mid-1980's. She has worked both as a consultant and directly for companies large and small, gaining experience with a wide range of studies and a variety of CDM systems. Since 2007, Susanne has been focusing on standard operating procedure (SOP) development, document management, and training plans for CDM and for other functions in clinical research and development.

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

Editorial
CRC Press
Año de publicación
2025
Idioma
Inglés
ISBN 10 
1032498234
ISBN 13 
9781032498232
Encuadernación
Tapa blanda
Número de edición
4
Número de páginas
270
Contacto del fabricante
CRC Press
https://www.routledge-ny.com

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BOCA RATON
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33487
Estados Unidos de America
Persona responsable
no disponible

Otras ediciones populares con el mismo título

9781032495583: Practical Guide to Clinical Data Management

Edición Destacada

ISBN 10:  1032495588 ISBN 13:  9781032495583
Editorial: CRC Press, 2024
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