Management of Data in Clinical Trials

Elizabeth M. McFadden

192 pages, parution le 11/09/2007 (2^eme édition)

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Résumé

A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:

The growing availability of "off-the-shelf" solutions for clinical trials
Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry
The increasing use of the Internet in the collection of data and management of trials
Regulatory requirements worldwideand compliance with the ICH Good Clinical Practice (GCP) Guidelines

Development of Standard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Sommaire

Introduction
Study Design and Planning
Data Definition, Forms, and Database Design
Computers in Clinical Trials: Hardware, Operating Systems, and Database Management Systems
Data Entry and Distributed Computing
Patient Registration
Local Data Management Systems
Central Quality Control of Data
Data Management and Good Clinical Practice
Software Tools for Trials Management
Follow-Up and Closeout Phase
Training and Education

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Caractéristiques techniques

	PAPIER
Éditeur(s)	Wiley
Auteur(s)	Elizabeth M. McFadden
Parution	11/09/2007
Édition	2^eme édition
Nb. de pages	192
Couverture	Broché
Intérieur	Noir et Blanc
EAN13	9780470046081
ISBN13	978-0-470-04608-1