Principle Investigator
Oya Beyan
Univ. Prof. Dr.
NUM-Codex plus
Kontakt
Ana Grönke (Dr. rer. nat.)
Projektkoordinator / Datenverwalter / wissenschaftlicher Mitarbeiter an der Universität zu Köln
Projekt Status
Abgeschlossen
Startdatum
Über das Projekt
Beschreibung
Aufbau einer bundesweit einheitlichen, datenschutzkonformen Infrastruktur zur Speicherung und Bereitstellung von COVID-19 Forschungsdatensätzen. Vorgesehen sind unter anderem eine umfassende Datenbank, Datenerfassungsinstrumente, Use & Access-Verfahren und eine Treuhandstelle.
Die Infrastruktur wird in der Lage sein, komplexe COVID-19 Forschungsdatensätze, darunter klinische Daten, Bilddaten und Daten zu Bioproben, multizentrisch, patientenbezogen und pseudonymisiert abzubilden und der Forschung zur Verfügung zu stellen.
Funding
Dieses Projekt wird unterstützt von
Resultate
Erfolge & Ergebnisse
The DZHK's clinical research platform was adapted to the requirements of COVID-19 research in just two months. This allowed the recruitment of patients and infected persons to begin immediately. From October 2020 to November 2021, complex data sets from 3,740 patients from the three NAPKON cohorts were recorded in the platform and the first research projects were carried out.
The DZHK e.V. will hand over the coordination of the clinical research platform to the Network University Medicine at the end of 2021. As the collection of data has proven successful, the infrastructure partners of the DZHK will continue to collect data on NAPKON patients in the future, then as direct partners of the NUM. The clinical research platform thus complements the MI-I research data platform, which is focussed on routine data.
Software development in the CODEX project is largely complete and includes, among other things NUM nodes to be installed at the sites for data delivery to the central platform, as well as the mediation of federated queries; the central research data platform for the central storage and analysis of pandemic data; decentralised, transactional components for the standardised connection of value-added services (e.g. the Smart Infection Control App SmICS) at the locations; the dashboard component for the visually informative presentation of aggregated pandemic data from the sites.
CODEX utilises the GECCO dataset created as part of NAPKON, a dataset based on the Fast Healthcare Interoperability Resources (FHIR), which was developed very quickly and successfully to provide the scientific community with a common language and working basis.
More than half of the 34 participating sites have already successfully participated in federated analyses based on the NUM node software. More than a third of the sites have successfully sent synthetic data to the central platform as part of the technical test. Further sites will follow suit.
Around half of the sites have already received a positive ethics vote, which allows data to be stored in the central platform if the Medical Informatics Initiative (MI-I) broad consent has been obtained. This also guarantees the provision of data via other consents that have been approved by the respective ethics committee.
The regulatory requirements created in this way, the data sets and network structures utilised enabled the complete publication of two publications and the submission of a further study. With the knowledge of the press, the care situation in the participating university hospitals could be presented visually and analysed in the dashboard.
