Clinical Data Management

Front Cover
John Wiley & Sons, Feb 3, 2000 - Medical - 354 pages
2 Reviews
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.
 

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Contents

The International Conference on Harmonisation and its Impact
21
Case Report Form Design
47
Data Capture
75
Planning and Implementation
89
Data Validation
109
Quality Assurance and Clinical Data Management
123
Performance Measures
143
Data Presentation
159
Database Design Issues for Central Laboratories
207
Computer Systems
229
Systems Software Validation IssuesClinical Trials Database
249
Reengineering the Clinical Data Management Process
271
Working with Contract Research Organizations
293
Data Management in Epidemiology and Pharmacoeconomics
307
Future Revisited
325
Index
347

Coding of DataMedLRA and other Medical Terminologies
177

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