Representation of domain knowledge needed to define relevant study variables for clinical trials in urology

An important aspect of clinical trial design is to define which study variables are relevant. This describes the data that have to be collected during the conduct of a trial. An underestimation of this aspect of trial design may lead to problems in the later data management process. The authors examined the knowledge needed to determine relevant study variables. This paper describes the development of a conceptualization model, also called an ontology, to represent this knowledge. This is the first step in building a knowledge-based system as a part of PROSYS.