The conceptual basis of WITH, a Collaborative Writer System of Clinical Trials

The paper illustrates the conceptual basis of the system WITH (Write on Internet clinical Trials in Haematology) which supports the collaborative writing of a clinical trial document. The requirements of this system have been defined analysing the writing process of a clinical trial and then modelling the content of its sections together with their logical and temporal relationships. This analysis generates a semantic network. The system WITH is based on XML mark-up language, and on a relational database management system. This choice guarantees: a) process standardisation; b) process management; c) efficient delivery of information-based tasks; and d) explicit focus on process design.