Wolfgang Kuchinke

clinical trials clinical research data sharing clinical data management data management infrastructure privacy research validation computer regulations data software development learning health system good clinical practice legal requirements personalized medicine gcp compliance standards cdisc knowledge requirements specification ecrin business model evaluation software tools services patient reported outcome patients knowledge management implementation computer system validation ethical principles analysis data ownership data mining open data patient empowerment decision support guidelines service provision integration system electronic data capture legal linked data software database information objects study protocol biomedical research cdash information model bridg share development obi pico ocre data integration information terminologies ontologies dataverse figshare dryad zenodo b2safe b2share recommendations data privacy data protection data reuse data repository user interface graphical interface temporal intervals time-stamp database time anchor time points eligibility criteria clinical sites hospital feasibility patient recruitment patient identification query generator query temporal relations usage scenarios business interactions domain scenario use cases scenario functionality design modification quality elicitation change management software requirement specification consistency stakeholder needs requirement engineering requirements validation master plan cohort study gord patient care randomisation diabetes observational studies safety ehr esource reciprocal exchange dna sequencing research services genome interventions quality standard network usability data management system interoperability ercin electronic health record enabler information sharing information technology patient-centric trials recruitment networks diagnosis genotype epidemiology sustainability models comparison us perspective europe european perspective learning lhs risk gamp edc consent risk management justice beneficence informed choices legal assessment tool medical data ethical requirements data repositories medical tool integration identifiable data patient regulatory ethics data access 21crfpart11 validation life cycle quality management validation policy master plan sop csv trust service exchange exchange customer relationship management service strategy assessment tools open access biosamples search