Management of data in clinical trials
著者
書誌事項
Management of data in clinical trials
（Wiley series in probability and mathematical statistics, . Probability and statistics）
Wiley, c1998
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注記
"A Wiley-Interscience publication."
Includes bibliographical references (p. 195-203) and index
内容説明・目次
内容説明
Timely, authoritative, complete-a comprehensive guide to managing data in clinical trials At some point during their training, virtually all health professionals are exposed to the theory of clinical trials, but few are taught about the practical details of organizing and conducting a clinical trial. This book fills that gap in training. Management of Data in Clinical Trials is a valuable working resource for anyone involved in any type of clinical trial-from large multicenter trials to small single-investigator studies. The information is relevant to trials in all disease areas, done in any clinical setting, and is general enough to be applicable both within and outside the United States.
This authoritative handbook offers in-depth coverage of accrual and follow-up phases of a clinical trial and provides valuable expert advice and step-by-step guidance on: Trial planning and resource assessment Developing a trial protocol and case report forms Selection and use of computers and software for clinical trials Eligibility checking and patient registration Data collection and data entry Quality control systems at the local and central levels Training and education of data management staff The role of data management in implementing good clinical practice (GCP) Development of software tools for trial management
目次
Study Design and Planning. Data Definition, Forms, and Database Design. Computers in Clinical Trials: Hardware, Operating Systems, and Database Management Systems. Data Entry and Distributed Computing. 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 Closeout Phase. Training and Education. Bibliography. Index.
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