Management of Data in Clinical Trials
Wiley Series in Probability and Statistics (Volume 1)
2. Edition September 2007
2007. 208 Pages, Hardcover
- Practical Approach Book -
ISBN 978-0-470-04608-1 - John Wiley & Sons
E-Books are also available on all known E-Book shops.
Management of Data in Clinical Trials, Second Edition explores data management-from study development to final analysis-and suggests alternative approaches, with guidelines on optimal approaches under various circumstances. It discusses various approaches to clinical trials for some of the major diseases and, now (in this edition), compares approaches in the U.S. and Europe. The text represents a valuable working resource for anyone involved in all types of clinical trials, from large multi-center trials to small single-investigator studies. The information is relevant to trials in all disease areas, done in any clinical setting. It offers in-depth coverage of accrual and follow-up phases of a clinical trial and provides valuable expert advice and step-by-step guidance on a multitude of methods.
From the contents
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.