Practical Guide to Clinical Data Management
Interpharm Press Inc (Verlag)
978-1-57491-043-8 (ISBN)
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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.
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
| Erscheint lt. Verlag | 31.1.1999 |
|---|---|
| Verlagsort | London |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 544 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| ISBN-10 | 1-57491-043-4 / 1574910434 |
| ISBN-13 | 978-1-57491-043-8 / 9781574910438 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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