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.

Product Details

• Amazon Sales Rank: #204143 in Books
• Published on: 2006-08-01
• Number of items: 1
• Binding: Hardcover
• 256 pages

Customer Reviews

not unusual for books in clinical data management
Sometimes it's hard to believe to find a good book in clinical data management. I read this book, and found it not worth the $$$. I would say try to get a job in DM, then after 1 yr, you will know much more than this book.

Useless book
From the editorial comments this book seemed exactly what I was looking for: "covering the basic data management tasks that all data managers must understand, focusing on the computer systems, including electronic data".
However, it is a collection of facts and bulleted lists of things to do while conducting a clinical trial and I still do not find a single tangible example. This makes all that is written impossible to grasp and understand.
Also, have you ever seen a book without a reference list? Well, this is the first book I have ever read that is not a fiction book that does not have a single reference nor a reference list at the end of the book or of each chapter. This makes the book almost completely useless.
One could pardon typographical errors such as "this data" if the book was better. In this context, this kind of typos only give an extended idea of the bad quality of this book.
I feel as if I wasted my money and time reading it.