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Practical Guide to Clinical Data Management / Edition 5
by Susanne ProkschaClinical 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… See more details below
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:
This book is your guide to finding the most successful and practical options for effective clinical data management.
Product Details
- 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)
Table of Contents
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
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