Managing time-stamped data is essential to clinical research activities and often requires the use of considerable domain knowledge. Adequately representing and integrating temporal data and domain knowledge is difficult with the database technologies used in most clinical research systems. There is often a disconnect between the database representation of research data and corresponding domain knowledge of clinical research concepts. In this paper, we present a set of methodologies for undertaking ontology-based specification of temporal information, and discuss their application to the verification of protocol-specific temporal constraints among clinical trial activities. Our approach allows knowledge-level temporal constraints to be evaluated against operational trial data stored in relational databases. We show how the Semantic Web ontology and rule languages OWL and SWRL, respectively, can support tools for research data management that automatically integrate low-level representations of relational data with high-level domain concepts used in study design.
