Managing data in surgical trials: a guide to modern-day data management systems.

Abstract

Data management is the strategy that is used for collecting, organizing, and managing data within an organization. Clinical data management plays a key part in the success of any clinical trial. The use of technology and computerized systems in the conduct of clinical trials has increased over the years and is now mainstream. The United States Food and Drug Administration has established requirements to ensure that electronic records and electronic signatures are trustworthy and reliable. Critical to the success of a data management protocol are the experienced members of the data management team. We review common aspects of data management and management systems.