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3rd Edition

Practical Guide to Clinical Data Management




ISBN 9781439848296
Published October 26, 2011 by CRC Press
296 Pages 26 B/W Illustrations

 
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Book Description

The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies.

See what’s new in the Third Edition:

  • A chapter on the clinical trial process that 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
  • Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout
  • Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns

The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance.

Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Table of Contents

STUDY STARTUP
The Data Management Plan
CRF Design Considerations
Database Design Considerations
Defining Edit Checks
Preparing to Receive Data
STUDY CONDUCT
Receiving Data on Paper
Overseeing Data Collection
Cleaning Data
Lab Data and Non-CRF Data
Collecting AE Data
Creating Reports and Transferring Data
STUDY CLOSEOUT
Preparing to Lock
Quality Control
Locking and Unlocking Studies
NECESSARY INFRASTRUCTURE
Standard Operating Procedures
Training
Controlling Access and Security
Working with CROs and Service Providers
CDM SYSTEMS
CDM Systems
Choosing Vendor Products
Implementing New Systems
System Validation
Test Procedures
Change Control
Coding Dictionaries

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Author(s)

Biography

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

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Author

Susanne Prokscha

Director, CDM, Onyx Pharmaceutical
San Mateo, CA, USA

Learn more about Susanne Prokscha »