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Synopsis
Clinical data management (CDM) has gone from predominantly relying on the collection of data on paper forms to using electronic data capture (EDC). Today, the assumption is that a trial will be conducted using EDC and that extenuating circumstances might lead to it being conducted using paper. This third edition emphasizes the EDC process. The chapters in the text are organized to represent the main elements of CDM: study startup, study conduct, and study closeout. In addition, a new chapter on the clinical trial process explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow.
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About the Author
Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.
"About this title" may belong to another edition of this title.
- PublisherCRC Press
- Publication date2011
- ISBN 10 1439848297
- ISBN 13 9781439848296
- BindingHardcover
- LanguageEnglish
- Edition number3
- Number of pages296
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