Includes bibliographical references (page 180) and index.
Introduction -- Study design and planning -- Data definition, forms, and database design -- Computer systems for data management and data entry -- Patient registration -- Local data management systems -- Central quality control of data -- Data management and good clinical practice -- Software tools for trials management -- Follow-up and close-out phase -- Training, education, and documentation -- Clinical trials collaboration models.
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A practical guide to managing data in clinical trials. Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. This edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology. It provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.