Management of Data in Clinical Trials (eBook)

Eleanor McFadden (Autor)

eBook Download: PDF

2007 | 2. Auflage
208 Seiten
John Wiley & Sons (Verlag)
978-0-470-18127-0 (ISBN)

Infos

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.

Autor

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.

Inhalt

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.

Produkt-Details

• Erscheint lt. Verlag: 28.6.2008
• Reihe/Serie: Wiley Series in Probability and Statistics
• Reihe/Serie: Wiley Series in Probability and Statistics
• Sprache: englisch
• Themenwelt: Mathematik / Informatik ► Mathematik ► Statistik
• Themenwelt: Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
• Themenwelt: Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
• Themenwelt: Technik
• Schlagworte: Computer Science • Datenorganisation • Informatik • Medizinische Statistik • Software Management • Software-Management • Spezialthemen Statistik • Statistics • Statistics Special Topics • Statistik • Time Series • Zeitreihen
• ISBN-10: 0-470-18127-3 / 0470181273
• ISBN-13: 978-0-470-18127-0 / 9780470181270