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Practical Guide to Clinical Data Management

Autor Susanne Prokscha
en Limba Engleză Hardback – 26 oct 2011
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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Specificații

ISBN-13: 9781439848296
ISBN-10: 1439848297
Pagini: 296
Ilustrații: 26 black & white illustrations, 3 black & white tables
Dimensiuni: 156 x 234 x 20 mm
Greutate: 0.54 kg
Ediția:Nouă
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

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

Notă biografică

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

Descriere

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.