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.
