Practical Guide to Clinical Data ManagementCRC Press, 31/01/1999 - 296 من الصفحات 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. |
المحتوى
The Data Management Plan | 3 |
Study Setup | 19 |
Tracking CRF Data | 37 |
Entering Data | 47 |
Quality Assurance and Quality Control | 54 |
Managing Lab Data | 63 |
Identifying and Managing Discrepancies | 77 |
Collecting Adverse Event Data | 87 |
Test Plans | 159 |
Migrating Legacy Data | 165 |
Change Control | 177 |
Creating Data Standards | 185 |
SOPs and Guidelines | 201 |
Working with CROS | 207 |
CRF Design Considerations | 217 |
Remote Data Entry | 227 |
Coding Reported Terms | 95 |
Creating Reports and Transferring Data | 107 |
Closing Studies | 115 |
Where Systems Come From | 123 |
Choosing Vendor Products | 131 |
Implementing New Systems | 139 |
System Validation | 147 |
Autocoder Algorithms | 235 |
Appendix A Data Management Plan Outline | 245 |
Implementation Plan Outline | 251 |
Glossary | 257 |
263 | |
264 | |
عبارات ومصطلحات مألوفة
adverse event terms analysis approach associated assure audit trail Autocoder Algorithms change control Chapter checks clinical data management clinical trials codelist coding dictionaries coding process collected companies complete configuration COSTART create data management group data management plan data management process data management system data structures data type database design defined detail discrepancy management document ID drug entry applications entry screens evaluation example identify impact in-house installation investigator kind lab data legacy data lookup manual match MedDRA ment patient performed pilot possible preferred term problems procedures protocol query forms record remote data entry reported terms require serious adverse event SOPs and guidelines specific sponsor standards step storage stored Study Setup system or application tasks test plan test scripts tion tracking transfer transformations updates usually validation plan values vendor product WHOART