Video Experimental Relacionado

Updated: Feb 26, 2026

Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics

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Diseño, implementación y análisis de un proceso de garantía de calidad para consentimientos informados utilizando el

Dana Stahl^1,2, Katrin Leyh^1,2, Alexander Rudolph^1,2

¹Trusted Third Party of the University Medicine Greifswald, Ellernholzstraße, Greifswald, Germany.

PLOS digital health

|February 24, 2026

Abstract:

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.

Palabras clave:

consentimiento informado ensayos clínicos garantía de calidad integridad de datos protección de datos registros investigación cardiovascular

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