Data management and statistical analysis

Abstract

The success of a clinical trial is dependent not only upon the design of a study protocol, but also upon the methods employed to ensure that clinical data are of high quality and in a suitable format for statistical analysis. These processes fall under the broad heading of ‘data handling’ and cover everything from data capture to monitoring, editing, database set-up, data entry, quality control and statistical analysis. A well designed data handling strategy will ensure the efficient collection and rapid processing of high quality clinical data. This chapter aims to give the reader a brief overview of some of key issues involved in these processes.