Description

Book 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.

Table of Contents

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

Practical Guide to Clinical Data Management

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    A Hardback by Susanne Prokscha

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      Publisher: CRC Press
      Publication Date: Publication Date: 26/10/2011
      ISBN13: 9781439848296, 978-1439848296
      ISBN10:
      Also in:
      Computer science Pharmaceutical chemistry and technology

      Description

      Book 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.

      Table of Contents

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

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