Practical Guide to Clinical Data Management - Hardcover

Prokscha, Susanne

Hardcover

ISBN 10: 1574910434 ISBN 13: 9781574910438

Publisher: CRC Press, 1999

Synopsis

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications.

With the tools this book provides, you'll learn how to:

Ensure that your DMB system is in compliance with federal regulations

Build a strategic data management and databsing plan

Track and record CRFs

Deal with problem data, adverse event data, and legacy data

Manage and store lab data

Identify and manage discrepancies

Ensure quality control over reports

Choose a CDM system that is right for your company

Create and implement a system validation plan and process

Set up and enforce data collection standards

Develop test plans and change control systems

This book is your guide to finding the most successful and practical options for effective clinical data management.

About this title

About the Author

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

Edition details

• Publisher: CRC Press
• Publication date: 1999
• Language: English
• ISBN 10: 1574910434
• ISBN 13: 9781574910438
• Binding: Hardcover
• Edition number: 1
• Number of pages: 296