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 databasing 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; and, 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.
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Über den Autor und weitere Mitwirkende
Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.