∗ 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
Clinical Data Management will be invaluable to anyone in the field of clinical data management within the pharmaceutical industry, or associated industries, and to all biomedical professionals working in clinical research.
The International Conference on Harmonisation and its Impact (B. Smith & L. Heywood).
Case Report Form Design (M. Avey).
Data Capture (E. Waterfield).
Planning and Implementation (C. Thomas).
Data Validation (P. Patel).
Quality Assurance and Clinical Data Management (H. Campbell & J. Sweatman).
Performance Measures (J. Wood).
Data Presentation (M. Mehra).
Coding of Data–MedDRA and other Medical Terminologies (E. Brown & L. Wood).
Database Design Issues for Central Laboratories (T. Tollenaere).
Computer Systems (L. Palma).
Systems Software Validation Issues–Clinical Trials Database Environment (S. Hutson).
Re–engineerng the Clinical Data Management Process (S. Arlington, et al.).
Working with Contract Research Organizations (K. Buchholz).
Data Management in Epidemiology and Pharmacoeconomics (M. Ryan & A. Pleil).
Future Revisited (R. Lane).