Practical Guide to Clinical Data Management
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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Practical Guide to Clinical Data Management
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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Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management

by Susanne Prokscha
Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management

by Susanne Prokscha

Hardcover(New Edition)

$250.00 
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Overview

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.

Product Details

ISBN-13: 9781439848296
Publisher: Taylor & Francis
Publication date: 10/26/2011
Edition description: New Edition
Pages: 296
Product dimensions: 6.00(w) x 9.30(h) x 0.80(d)

About the Author

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

Table of Contents

Study Startup. Study Conduct. Study Closeout. Necessary Infrastructure. CDM Systems.

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