Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.
It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Arvustused
"The key to enduring research is data quality and data quality depends upon data management. How fortunate then that the start of the New Millennium sees the publication of the second edition of 'Clinical Data Management'. ... Admirably concise and authoritatively penned, it provides an excellent introduction to a subject at the heart of pharmaceutical R&D.", Dr Hugh Boardman, Partner in Boardman Clarke, Pharmaceutical Physician#
Contributors vii Foreword xi Preface xiii
Chapter Review 1(20) Stuart W. Cummings The International Conference on Harmonisation and its Impact 21(26) Beverley Smith Linda Heywood Case Report Form Design 47(28) Moura Avey Data Capture 75(14) Emma Waterfield Planning and Implementation 89(20) Chris Thomas Data Validation 109(14) Pankaj `Panni Patel Quality Assurance and Clinical Data Management 123(20) Heather Campbell John Sweatman Performance Measures 143(16) Jon Wood Data Presentation 159(18) Munish Mehra Coding of Data---MedDRA and other Medical Terminologies 177(30) Elliot G. Brown Louise Wood Database Design Issues for Central Laboratories 207(22) Tom Tollenaere Computer Systems 229(20) Louise Palma Systems Software Validation Issues---Clinical Trials Database Environment 249(22) Steve Hutson Re-engineering the Clinical Data Management Process 271(22) Steve Arlington Paul Athey John Carroll Alistair Shearin Working with Contract Research Organizations 293(14) Kenneth Buchholz Data Management in Epidemiology and Pharmacoeconomics 307(18) Michael F. Ryan Andreas M. Pleil Future Revisited 325(22) Ruth Lane Index 347
Richard K. Rondel is the editor of Clinical Data Management, 2nd Edition, published by Wiley.
Sheila A. Varley is the editor of Clinical Data Management, 2nd Edition, published by Wiley.
Colin F. Webb is the editor of Clinical Data Management, 2nd Edition, published by Wiley.
