A valuable new edition of the trusted, practical guide to managing data in clinical trialsRegardless 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 trialsPotential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industryThe increasing use of the Internet in the collection of data and management of trialsRegulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) GuidelinesDevelopment of Standard Operating Procedures for the conduct of clinical trialsComplete 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.
Author(s): Eleanor McFadden
Edition: 2
Year: 2007
Language: English
Pages: 208
MANAGEMENT OF DATA IN CLINICAL TRIALS......Page 4
CONTENTS......Page 10
Preface......Page 12
Acknowledgments......Page 14
1 Introduction......Page 16
2 Study Design and Planning......Page 27
3 Data Definition, Forms, and Database Design......Page 48
4 Computer Systems for Data Management and Data Entry......Page 71
5 Patient Registration......Page 91
6 Local Data Management Systems......Page 109
7 Central Quality Control of Data......Page 121
8 Data Management and Good Clinical Practice......Page 136
9 Software Tools for Trials Management......Page 155
10 Follow-Up and Close-Out Phase......Page 170
11 Training, Education, and Documentation......Page 178
12 Clinical Trials Collaboration Models......Page 190
Bibliography......Page 195
Index......Page 196
