McFadden Management of Data in Clinical Trials

2. Auflage 2008
ISBN: 978-0-470-18127-0
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, Band 1, 208 Seiten, E-Book

Reihe: Wiley Series in Probability and Statistics

A valuable new edition of the trusted, practical guide to managingdata in clinical trials
Regardless of size, type, or complexity, accurate results for anyclinical trial are ultimately determined by the quality of thecollected data. Management of Data in Clinical Trials, SecondEdition explores data management and trial organization as the keysto developing an accurate and reliable clinical trial. With a focuson the traditional aspects of data collection as well as recentadvances in technology, this new edition provides a complete andaccessible guide to the management structure of a clinical trial,from planning and development to design and analysis. Practicalapproaches that result in the collection of complete and timelydata are also provided.
While maintaining a comprehensive overview of the knowledge andtools that are essential for the organization of a modern clinicaltrial, the author has expanded the topical coverage in the SecondEdition to reflect the possible uses of recent advances intechnology in the data collection process. In addition, the SecondEdition discusses the impact of international regulations governingthe conduct of clinical trials and provides guidelines on ensuringcompliance with national requirements.
Newly featured topics include:
* The growing availability of "off-the-shelf" solutions forclinical trials
* Potential models for collaboration in the conduct of clinicaltrials between academia and the pharmaceutical industry
* The increasing use of the Internet in the collection of dataand management of trials
* Regulatory requirements worldwide and compliance with the ICHGood Clinical Practice (GCP) Guidelines
* Development of Standard Operating Procedures for the conduct ofclinical trials
Complete with chapter summaries that reinforce key points aswell as over one hundred examples, Management of Data in ClinicalTrials, Second Edition is an ideal resource for practitioners inthe clinical research community who are involved in the developmentof clinical trials, including data managers, research associates,data coordinators, physicians, and statisticians. This book alsoserves as an excellent supplemental text for courses in clinicaltrials at both the undergraduate and graduate levels.

Autoren/Hrsg.

McFadden, Eleanor

Inhaltsverzeichnis

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.

Über Autor(innen)

Eleanor McFadden is Managing Director at Frontier Science (Scotland) Ltd. in the United Kingdom and is the current president of the Society for Clinical Trials. With almost thirty years of experience in clinical trials data management in both academia and industry, she has contributed to and published numerous books and articles on the topic and has been an invited lecturer at various universities and clinical centers worldwide.