Management of Data in Clinical Trials

ISBN-13: 9780470046081 / Angielski / Twarda / 2007 / 208 str.

Elizabeth M. McFadden

Opis

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.

Spis treści

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.

O autorze

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.