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.

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.

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

Management of Data in Clinical Trials, Second Edition also discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Contents

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

Index

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ORDER NOW Management of Data in Clinical Trials Second edition by Eleanor McFadden 2007 • 208 pages • $115.95 + shipping Texas residents please add 6.75 % sales tax