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.
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 EDe, 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.
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