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OverviewTimely, 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 Full Product DetailsAuthor: Eleanor McFaddenPublisher: John Wiley and Sons Ltd Imprint: John Wiley & Sons Inc Dimensions: Width: 16.30cm , Height: 2.10cm , Length: 24.20cm Weight: 0.510kg ISBN: 9780471303169ISBN 10: 047130316 Pages: 232 Publication Date: 07 November 1997 Audience: College/higher education , Professional and scholarly , Undergraduate , Postgraduate, Research & Scholarly Format: Hardback Publisher's Status: Out of Stock Indefinitely Availability: Out of stock ![]() Table of ContentsStudy 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.ReviewsThe book is useful for anyone who wants to understand the entire process and how decision made at one stage can have profound affects on the next. ( Journal of Clinical Research Best Practices , May 2006). ..interesting and well-written...the book will be of most use in someone's personal collection. I would most definitely recommend this book to a colleague.... I would also recommend this book as a course test. ( Statistical Methods in Medical Research , Vol. 10, No. 1, 2001) The book is useful for anyone who wants to understand the entire process and how decision made at one stage can have profound affects on the next. ( Journal of Clinical Research Best Practices, May 2006) <p> .,. interesting and well-written...the book will be of most use in someone's personal collection. I would most definitely recommend this book to a colleague.... I would also recommend this book as a course test. ( Statistical Methods in Medical Research, Vol. 10, No. 1, 2001) The book is useful for anyone who wants to understand the entire process and how decision made at one stage can have profound affects on the next. ( Journal of Clinical Research Best Practices, May 2006) .. .interesting and well-written...the book will be of most use in someone's personal collection. I would most definitely recommend this book to a colleague.... I would also recommend this book as a course test. ( Statistical Methods in Medical Research, Vol. 10, No. 1, 2001) Author InformationELEANOR McFADDEN is Director of the Coordinating Center for the Eastern Cooperative Oncology Group at Frontier Science and Technology Research Foundation, Brookline, Massachusetts. She has been involved in clinical trials data management for twenty years and has published articles and taught courses on various aspects of trial management. Tab Content 6Author Website:Countries AvailableAll regions |