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Practical Guide to Clinical Data Management, Second Edition
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by Susanne Prokscha
Sales Rank: 633935
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List Price: $159.95
$127.96
At Amazon
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Hardcover: 256 pages
Publisher: CRC; 2 edition August 1, 2006
Language: English
ISBN-10: 0849376157
ISBN-13: 978-0849376153
Product Dimensions:
9.3 x 6.3 x 0.9 inches
Shipping Weight: 1.2 pounds
Product Description
The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - · A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures · Practices for both electronic data capture (EDC)-based and paper-based studies · A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.
Customer Reviews & Comments
I have to disagree with the other reviewers here. This is exactly the kind of guide for which I was looking. New to the clinical research field (but not to information management), I wanted that "missing manual" for data management from this field's unique perspective and needs. I've looked at a lot of texts (both on Amazon and in academic libraries) and was surprised that there weren't more books like this out there. Something that is basic, that starts with the nuts & bolts of clinical data management. Yes, of course, working in the field will help tremendously. And I'm sure there are more in-depth books out there that take these concepts and add layers of complexity. But this gives you a really good overview with a solid foundation. I'm currently using a library copy, but am seriously considering buying one for my own library & reference. The price is steep, but it's market economics -- there's little or no competition for this type of manual and the publisher & author apparently know that. Pure supply & demand.
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Practical Guide to Clinical Data Management, Second Edition
List Price: $159.95
Available from Amazon
Price: $127.96
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