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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.

Book details

Format
Hardback
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Author
Susanne Prokscha (Clinical Development Operations Excellence, California, USA), CRC Press Inc, Taylor & Francis Inc
ISBN-13
9781439848296
Publication date
2011-10-26
Pages
274
Edition
3rd edition
Dimensions
156 mm × 234 mm
Weight
558 g
Country of origin
GB

Hardback

Practical Guide to Clinical Data Management

door Susanne Prokscha (Clinical Development Operations Excellence, California, USA)

€ 197,99
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