Beyond the Basics

Summary: The integrity of a large clinical trial in surgery is dependent on the quality of the data management. With multiple centers recruiting patients across several sites, thousands of dataforms are completed each week. These data need to be transferred to the Methods and Coordinating Center in a timely manner. This article outlines a contemporary approach to managing data in multicenter trials. We propose an Internet-based data management system that allows facile data entry and ongoing quality assurance to optimize the efficiency and quality of data collection in large surgical trials.