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OverviewIntroducing professionals to the role of data management in clinical trials, Practical Guide to Clinical Data Management highlights current thinking about data management, focusing on responsibilities that typical data managers have today. This second edition includes detailed requirements of 21CFR11, the standard for electronic records and signatures. It features new chapters on training of data collection staff as well as controlling access and security. It explores software applications for CDM and explains how to use computerized data collection software. It addresses clinical data for drug and medical device trials. It also presents overviews of various documents for use as templates. Full Product DetailsAuthor: Susanne Prokscha (Redwood City, California, USA)Publisher: CRC Press Imprint: CRC Press ISBN: 9786611081317ISBN 10: 6611081313 Pages: 254 Publication Date: 01 January 2007 Audience: General/trade , General Format: Electronic book text Publisher's Status: Active Availability: Out of stock The supplier is temporarily out of stock of this item. It will be ordered for you on backorder and shipped when it becomes available. Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |