Clinical Data Management

by Rondel, Richard K.; Varley, Sheila A.; Webb, Colin F.

• ISBN13: 9780471983293
• ISBN10: 0471983292
• Edition: 2nd
• Format: Hardcover
• Copyright: 2000-02-03
• Publisher: WILEY

Summary

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.

Author Biography

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.

Table of Contents

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