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Management of Data in Clinical Trials, McFadden, Eleanor, 9780470046081
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eBay-Artikelnr.:135914786171
Artikelmerkmale
- Artikelzustand
- Book Title
- Management of Data in Clinical Trials
- ISBN
- 9780470046081
Über dieses Produkt
Product Identifiers
Publisher
Wiley & Sons, Incorporated, John
ISBN-10
0470046082
ISBN-13
9780470046081
eBay Product ID (ePID)
58995858
Product Key Features
Number of Pages
208 Pages
Language
English
Publication Name
Management of Data in Clinical Trials
Publication Year
2007
Subject
Clinical Medicine, Probability & Statistics / General
Features
Revised
Type
Textbook
Subject Area
Mathematics, Medical
Series
Wiley Series in Probability and Statistics Ser.
Format
Hardcover
Dimensions
Item Height
0.7 in
Item Weight
16.8 Oz
Item Length
9.4 in
Item Width
6.5 in
Additional Product Features
Edition Number
2
Intended Audience
Scholarly & Professional
LCCN
2007-013685
Dewey Edition
22
Series Volume Number
23
Illustrated
Yes
Dewey Decimal
615.5072/4
Table Of Content
Preface. Acknowledgments. 1. Introduction. 2. Study Design and Planning. 3. Data Definition, Forms and Database Design. 4. Computer Systems for Data Management and Data Entry. 5. Patient Registration. 6. Local Data Management Systems. 7. Central Quality Control of Data. 8. Data Management and Good Clinical Practice. 9. Software Tools for Trials Management. 10. Follow-Up and Close-Out Phase. 11. Training, Education and Documentation. 12. Clinical Trials Collaboration Models. Bibliography. Index.
Edition Description
Revised edition
Synopsis
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 worldwide and 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., 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 worldwide and 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., This book explores data management from study development to final analysis and suggests alternative approaches, with guidelines on optimal approaches under various circumstances. It contains discussions of the various approaches to clinical trials for some of the major diseases. This second edition compares approaches in the U.S., 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 worldwide and 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.
LC Classification Number
R853.C55M39 2008
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