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The paper illustrates the system WITH (Write on Internet clinical Trials in Haematology) which supports the writing of a clinical trial (CT) document. The requirements of this system have been defined analysing the writing process of a CT and then modelling the content of its sections together with their logical and temporal relationships. The system WITH(More)
Clinical investigations (CIs) are carried out to demonstrate safety and efficacy of new Medical Devices (MDs). The presence of many stakeholders participating in CIs makes it necessary to develop a common standard language to achieve semantic interoperability among systems and organizations. In Italy the National Research Council is carrying out a project(More)
In the paper some results of the modelling of the clinical trial (CT) process are presented. CT research is a complex process which includes the protocol editing, its use and implementation in the CT experimentation, and the evaluation of the results. To improve the medical research, it is necessary to consider the CT research process as a whole. We(More)
This paper proposes a conceptual framework to design a dimensional model based on the HL7 Clinical Document Architecture (CDA) standard. The adoption of this framework can represent a possible solution to facilitate the integration of heterogeneous information systems in a clinical data warehouse. This can simplify the Extract, Transform and Load (ETL)(More)
The paper describes the design of a module that manages Serious Adverse Events (SAEs) reporting within a Clinical investigation on Medical devices. This module is integrated in a Medical Device Information System (MEDIS) that collects data and documents exchanged between applicants and the National Competent Authority during the clinical investigation(More)