Practical Guide to Clinical Data Management

Examining the role of data management in clinical trials, Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. It incorporates the modifications that data management groups have made under 21 CFR 11 and examines the differences in data management between EDC-based studies and paper-based studies. The book has been reorganized into three sections. Part I covers the basic data management tasks. Part II addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations. Part III focuses on the computer systems.