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Stahl, D.* ; Leyh, K.* ; Rudolph, A.* ; Blumentritt, A.* ; Weitmann, K.* ; Kraus, M. ; Trebing, J.* ; Hoffmann, J.* ; Sedaghat-Hamedani, F.* ; Meder, B.* ; Hoffmann, W.*

Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example.

PLOS Digit Health 5:e0000798 (2026)

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	Open Access Gold

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To collect sensitive patient data during clinical trials, the Informed Consent (IC) of the participants must be obtained beforehand. If the IC is not correct and complete, the document cannot be used to represent the will of the participant and will not be considered a legally valid document. However, few studies have examined the quality of the IC and the IC-quality found is unfortunately not satisfactory. The aim of this article is to describe the development of an IC quality assurance concept and to report the results of an evaluation using the example of a German Centre for Cardiovascular Research (DZHK) registry. All quality issues identified during the study were documented. These were aggregated into the quality indicators "Completeness", "Consistency of Data", "Correctness" and "Validity". Of 2,453 ICs, 1,588 had at least one quality issue; 99.8% of them were resolved. In addition, training sessions were conducted with study staff to raise awareness of the importance of correct IC collection, including documentation, and to minimize quality issues. Our data exemplify that improvements in the recording of ICs by the study staff can be achieved. This evaluation shows the value and importance of continuous IC quality control.

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Publication type Article: Journal article

Document type Scientific Article

Keywords Translational Registry

ISSN (print) / ISBN 2767-3170

e-ISSN 2767-3170

Journal PLOS Digital Health

Quellenangaben Volume: 5, Issue: 2, Article Number: e0000798

Publisher Public Library of Science (PLoS)

Publishing Place 1160 Battery Street, Ste 100, San Francisco, Ca 94111 Usa

Reviewing status Peer reviewed

Institute(s) Institute of Epidemiology (EPI)

Grants Federal Ministry of Education and Research (BMBF), Germany
German Centre for Cardiovascular Research (DZHK)