An improved process for the creation, maintenance, and documentation of analysis-ready data

摘要

The development of analysis-ready data for clinical trials is a complicated process that is often problematic. Not only are the data inherently complex, but also analytical and reporting requirements tend to evolve over a period of time. Additional difficulties arise because of the number of individuals working with the data and the varied uses of the data. A new approach is described that greatly facilitates the creation, maintenance, and documentation of these data. Results are encouraging and include contributing to high quality and improved productivity. Copyright 2006 Drug Information Association, Inc.