Adverse event reporting module embedded in a clinical investigation monitoring system

The paper describes MEDIS, a monitoring system of Clinical Investigations (CIVs) on medical devices that collects data and documents exchanged between applicants and the National Competent Authority during the whole CIV lifecycle. In particular it outlines the design and development of a module that manages Serious Adverse Events (SAE) information providing a conceptual model and an example of the interface used to capture data of new SAE.