Adverse event reporting module embedded in a clinical investigation monitoring system (Contributo in atti di convegno)

Type
Label
  • Adverse event reporting module embedded in a clinical investigation monitoring system (Contributo in atti di convegno) (literal)
Anno
  • 2012-01-01T00:00:00+01:00 (literal)
Alternative label
  • Daniela Luzi Fabrizio Pecoraro (2012)
    Adverse event reporting module embedded in a clinical investigation monitoring system
    in Proceedings of Terzo Congresso del Gruppo Nazionale di Bioingegneria (GNB), Rome, Italy
    (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#autori
  • Daniela Luzi Fabrizio Pecoraro (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • Istituto di Ricerche sulla Popolazione e le politiche sociali (literal)
Titolo
  • Adverse event reporting module embedded in a clinical investigation monitoring system (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#isbn
  • 978-88-555-3182-5 (literal)
Abstract
  • 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. (literal)
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