Design and evolution of the data management systems in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial

This paper describes the design and evolution of the data management systems developed in support of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. These systems span platforms from stand-alone computers to distributed systems on local area networks to mainframes. Allowing all of these systems to share appropriate information electronically introduces integration, synchronization, testing,and support challenges. For each platform, applications were developed to handle data entry, editing, trial management, reporting, telecommunications, and data sharing. Approaches to issues such as level of data access, integration with other, existing applications, and handling the expansion of the protocol are discussed.