Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs

Chapter 14

Clinical Data Management

Ruth McBride

14.1 Introduction

Even before computers were used in clinical research, we have been collecting data, organizing it, and analyzing it. Since the advent of computers and specialized data management software, the area of clinical data management has matured to the point that clinical investigators can count on having complete, reliable, and current data for interim and final analyses. Clinical data management, as the name implies, is data management focused on clinical data, but not on all clinical data. Clinical data are collected for a variety of purposes, as part of electronic medical records to manage medical or dental practice, as part of billing information, and in the context that this section of the encyclopedia will discuss, to support clinical research and, in particular, clinical trials. In this context, there are some specialized requirements of a data management system or process. First of all, data collected for clinical trials research is primarily study participant-centric (or patient centric). This implies a hierarchical data structure where most data records are tied to participants. Within participant, data are further organized by “visit.” Contrast this data structure with databases designed to support, for example, banking or airlines. These databases are designed to support many transactions and are more typically relational in structure. Although commercial clinical data management systems are built on relational ...