Edited by Eleanor McFadden, ECOG Coordinating Center/Frontier Science (affiliated with Harvard University), Brookline, USA

The first book to concentrate solely on this topic, the Management of Data in Clinical Trials takes the reader from initial study development to final analysis. International in scope, it provides information on alternative approaches to the conduct of the trial, and gives pointers to the optimal approach under various circumstances.

• Topics discussed include planning phases, use of technology, training education and how to implement good clinical practice
• Applicable both to large multi-centre trials and small, single investigator studies
• Highlights differences in approach between some of the major disease areas where clinical trials are carried out
• Suitable for use by physicians, nurses, statisticians and data managers

Contents

• Study Planning/Design
• Data Definition, Forms and Database Design
• Computers in Clinical Trials - Hardware, Software and Database Management Systems
• Data Entry and Distributed Computing
• Patient Registration; Local Data Management Systems
• Central Quality Control of Submitted Data
• Data Management and Good Clinical Practice
• Software Tools; Reporting and Close-Out
• Training and Education
• Index