Wolfgang Kuchinke

research clinical studies clinical trials database data sharing software development infrastructure data protection open data medicine data clinical research data management computer system validation requirements ethics services privacy privacy protection ehr learning health system legal requirements compliance knowledge management analysis ethical requirements guidance decision support patient empowerment personalised medicine sensitive data patient data software requirements validation master plan good clinical practice validation data mining personalized medicine tool integration it infrastructure prediction usability knowledge data security gcp information technology information user interface regulations legal collaboration service exchange data ownership integration model archiving temporal operators time stamps time points time temporal relations query generation interface design patient identification eligibility recruitment electronic patient record accessibility user authentication identity provider shibboleth legal assessment tool biobank rems secure access investigator prom source data esource business model competency pcr software tools statistics software test quality control patient care controlled clinical trials observational studies legislation electronic health record patient-centric network evaluation data standards health care epidemiology genotype lhs conference comparison europe learning legal interoperability open science database rights data bridges complexity quality assurance agile validation agile agile software development quality management computer drug development home improvement considerations animal models experimental process cell therapy gene therapy reverse engineering preclinical research translational research mediator knowledge base biosamples publications linking cross-domain data repository data life cycle documents electronic signatures persistence digital long-term preservation formats trial master file archive market analysis medical risks informed consent requirement engineering ethical concepts ethical diagnosis user experience decision cluster analysis autonomy ethical analysis intellectual property law gdpr regulatory open source sustainability benefit healthcare interdependencies data flow data governance ckan dataverse fair data ecosystem repositories workshop risk management filters linked data research scenarios zones policies anonymization framework study storage data exchange study migration use cases standards cdisc