Product Description
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 will help 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 stor lab data·Identify and
manage discrepancies·Ensure qulatiy control over reports·Choose a CDM
system that is right for your company·Create and implement a system
valication plan and process·Set up and enforce data collection
standards·Develop test plans and change control systemsThis book will be
your guide in finding the most successful and practical options for
effective clinical data management.
