Pract ical Guide to CLINICAL DATA MANAGEMENT

Introducing professionals to the role of data management in clinical trials, Practical Guide to Clinical Data Management highlights current thinking about data management, focusing on responsibilities that typical data managers have today. This second edition includes detailed requirements of 21CFR11, the standard for electronic records and signatures. It features new chapters on training of data collection staff as well as controlling access and security. It explores software applications for CDM and explains how to use computerized data collection software. It addresses clinical data for drug and medical device trials. It also presents overviews of various documents for use as templates