Practical Guide to Clinical Data Management3rd Edition

Susanne Prokscha

ISBN 10: 1439848297 / ISBN 13: 9781439848296

Published by CRC Press, 2011

About this Item

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Bibliographic Details

• Title: Practical Guide to Clinical Data Management3rd Edition
• Publisher: CRC Press
• Publication Date: 2011
• Language: English
• ISBN 10: 1439848297
• ISBN 13: 9781439848296
• Binding: Hardcover
• Edition: 3rd Edition, International Edition
• Condition: Used books

About this title

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.

About the Author

Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.