by Dr. Richard Rondel, University of Surrey, UK, Sheila Varley, Covance CAPS Ltd., Berkshire, UK and Dr. Colin Webb, AMGEN, Cambridge, UK

Clinical data management is the function within pharmaceutical companies which takes completed clinical trial case record forms and processes them for statistical analysis and formal reporting. Proper and efficient procedures are required to satisfy both corporate objectives and quality audit by regulatory authorities.

Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. This easy-to-use text has been written by contributors who are known for their extensive experience in industry and who have been drawn from multi-national companies worldwide.

Contents

Section 1 - Regulatory Background
Chapter 1: ICH and its impact Section 2 - Clinical Data Management Processes
Chapter 2: CRF Design; Chapter 3: Data Input; Chapter 4: Planning & Initiation; Chapter 5: Data Management Plans & Data Validation Activities; Chapter 6: Data Quality (Section 2); Chapter 7: Performance Measures; Chapter 8: Data Access and Presentation; Chapter 9: Training; Chapter 10: Coding Dictionaries; Chapter 11: Central Laboratories;

Section 3 - Computer Systems for Clinical Data Management
Chapter 12: Clinical Data Management; Computer Systems; Chapter 13: Systems Validation Issues - Clinical Trial Database; Environment

Section 4 - Future Directions
Chapter 14: Re-engineering the Clinical Data Management Process; Chapter 15: Working with CROs; Chapter 16: Pharmacoeconomics & Epidemiology; Chapter 17: Future revisited