Description
Book SynopsisA 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 r
Table of ContentsPreface.
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.
