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Gesundheit – gemeinsam. Kooperationstagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP), Deutschen Gesellschaft für Epidemiologie (DGEpi), Deutschen Gesellschaft für Medizinische Soziologie (DGMS) und der Deutschen Gesellschaft für Public Health (DGPH)

08.09. - 13.09.2024, Dresden

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Integration of trusted third party software into an EDC system for data protection-compliant identity management, consent management and pseudonymization in medical research studies

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  • Hauke Schneiderheinze - Trusted Third Party of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • Johnannes Wagner - Trusted Third Party of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • Marcus Wurlitzer - Research IT, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
  • Oliver Köckritz - Research IT, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
  • Nils Dittberner - InterSystems GmbH, Darmstadt, Germany
  • Martin Bialke - Institut für Community Medicine, Universitätsmedizin Greifswald, Greifswald, Germany
  • Peter Penndorf - Institut für Community Medicine, Universitätsmedizin Greifswald, Greifswald, Germany
  • Arne Blumentritt - Unabhängige Treuhandstelle der Universitätsmedizin Greifswald, Greifswald, Germany
  • Jan Erik Gewehr - Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Gesundheit – gemeinsam. Kooperationstagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP), Deutschen Gesellschaft für Epidemiologie (DGEpi), Deutschen Gesellschaft für Medizinische Soziologie (DGMS) und der Deutschen Gesellschaft für Public Health (DGPH). Dresden, 08.-13.09.2024. Düsseldorf: German Medical Science GMS Publishing House; 2024. DocAbstr. 838

doi: 10.3205/24gmds102, urn:nbn:de:0183-24gmds1028

Published: September 6, 2024

© 2024 Schneiderheinze et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Introduction: Medical research studies which involve electronic data capture of sensitive data about human subjects need to manage medical and identifying participant data in a secure manner. To protect the identity of data subjects, an independent trusted third party should be responsible for pseudonymization and management of the identifying data.

Methods: We have developed a web-based integrated solution that combines REDCap as an electronic data capture system with the trusted third party software tools of the University Medicine Greifswald, which provides study personnel with a single user interface for both clinical data entry and management of identities, pseudonyms and informed consents.

Results: Integration of the two platforms enables a seamless workflow of registering new participants, entering identifying and consent information, and generating pseudonyms in the trusted third party system, with subsequent capturing of medical data in the electronic data capture system, while maintaining strict separation of medical and identifying data in the two independently managed systems.

Conclusion: Our solution enables a time-efficient data entry workflow, provides a high level of data protection by minimizing visibility of identifying information and pseudonym lists, and avoids errors introduced by manual transfer of pseudonyms between separate systems.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.