Practical Guide to Clinical Data Management - Hardcover

Prokscha, Susanne

Hardcover

ISBN 10: 0849376157 ISBN 13: 9780849376153

Publisher: CRC Press, 2006

Synopsis

The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.

Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling.

Updates to the Second Edition include -

A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures

Practices for both electronic data capture (EDC)-based and paper-based studies

A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations

The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task.

Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

About this title

Product Description

Examining the role of data management in clinical trials, this work provides an introduction to the key process elements of clinical data management. It incorporates the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures.

Synopsis

Examining the role of data management in clinical trials, "Practical Guide to Clinical Data Management, Second Edition" provides a solid introduction to the key process elements of clinical data management. It incorporates the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures. This edition examines the differences in data management between EDC-based studies and paper-based studies.

Edition details

• Publisher: CRC Press
• Publication date: 2006
• Language: English
• ISBN 10: 0849376157
• ISBN 13: 9780849376153
• Binding: Hardcover
• Edition number: 2
• Number of pages: 252