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Practical Guide to Clinical Data Management / Edition 5

by Susanne Prokscha

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Hardcover

Overview
Product Details
Related Subjects
Table of Contents

Overview

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.

ISBN-13:: 9781574910438
Publisher:: Taylor & Francis
Publication date:: 01/31/1999
Edition description:: Older Edition
Pages:: 296
Product dimensions:: 6.14(w) x 9.40(h) x 0.89(d)

Related Subjects

include:
ELEMENTS OF THE PROCESS Data Management Plan Study Setup Tracking CRF Data Entering Data Managing Lab Data Identifying and Managing Discrepancies Collecting Adverse Event Data Coding Reported Terms Creating Reports and Transferring Data Closing Studies Identifying & Managing Discrepancies

CDM SYSTEMS Where Systems Come From Choosing Vendor Products Implementing New Systems Systems Validation Test Plans Migrating Legacy Data Change Control

SPECIAL TOPICS Creating Data Standards SOPs and Guidelines Working With CROs CRF Design Considerations Remote Data Entry Autocoder Algorithms

APPENDICES Appendix A: Data Management Plan Outline Appendix B: Database Design Document Outline Appendix C: Validation Plan Outline Appendix D: Test Plan Outline

GLOSSARY SELECTED READING INDEX