Article
Development, Involvement and Value of an Overarching In-House Registry for Clinical Trials
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Authors
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Torge Ablaß
- IT Center for Clinical Research, Lübeck (ITCR-L), Universität zu Lübeck, Lübeck, Germany; Medical Data Integration Center, University Hospital Schleswig-Holstein, Lübeck, Germany
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Friedrich Simon
- IT Center for Clinical Research, Lübeck (ITCR-L), Universität zu Lübeck, Lübeck, Germany
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Christina Schwitlick
- Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Lübeck, Germany; University Cancer Center Schleswig-Holstein, University Hospital Schleswig-Holstein, Kiel, Lübeck, Germany
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Denise Olbrich
- Center for Clinical Trials, Universität zu Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany
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Kristina Brandt
- Center for Clinical Trials, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany
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Ina Hohensee
- IT Center for Clinical Research, Lübeck (ITCR-L), Universität zu Lübeck, Lübeck, Germany
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Nikolas von Bubnoff
- Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Lübeck, Germany; University Cancer Center Schleswig-Holstein, University Hospital of Schleswig-Holstein, Lübeck, Germany
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Claudia D. Baldus
- Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Kiel, Lübeck, Germany; University Cancer Center Schleswig-Holstein, University Hospital of Schleswig-Holstein, Kiel, Lübeck, Germany
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Josef Ingenerf
- Institute of Medical Informatics, University of Lübeck, Lübeck, Germany; IT Center for Clinical Research, Lübeck (ITCR-L), Universität zu Lübeck, Lübeck, Germany
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Björn Schreiweis
- Christian-Albrechts-Universität zu Kiel und Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany; Medical Data Integration Center, University Hospital Schleswig-Holstein, Kiel, Germany
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Ann-Kristin Kock-Schoppenhauer
- IT Center for Clinical Research, Lübeck (ITCR-L), Universität zu Lübeck, Lübeck, Germany; Medical Data Integration Center, University Hospital Schleswig-Holstein, Lübeck, Germany
| Published: | September 6, 2024 |
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Outline
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Introduction: Conducting clinical studies is an integral part of the clinical research repertoire of university hospitals. A wealth of organizational competences must always be available in a central location and in an up-to-date form for appropriate administration. Information such as the number of ongoing studies, the number of serious adverse event notifications and the number of enrolled participants or studies per clinic is required for tasks related to sponsor quality management, key performance indicators or public relations. A registry for clinical trials can answer these questions and enhance the exchange of information between the treatment providers and IT systems.
Methods: Requirements for an in-house registry for clinical trials were defined in a multidisciplinary task force with a primary focus on oncology. The requirements included interfaces to other internal systems and international primary registries and the key ability to create customized reports to fulfill the obligation to provide evidence. An analysis of existing data sets and needed attributes resulted in a specific harmonized data set as a basis for the registry.
Results: The study registry has been in productive use since May 2020 and internal interfaces have been implemented between the study registry, the hospital management system and the financial management system to ensure consistency between these three systems and the documented studies. Manually recorded data is enhanced by interfaces to primary registers. The comprehensive data set in the study register enables the creation of individual queries at any time for a variety of questions.
Discussion: The UKSH study register has already demonstrated its usefulness in various applications and several projects. The extensive data set and the modular realization allows many current and future requirements to be met. Further interfaces and extensions are already planned. Further work is needed as interfaces in the central study registries are not always comprehensive and no generic implementation is available making individual solutions necessary.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
