Development, Involvement and Use of an Overarching In-House Registry for Clinical Trials.

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, and the number of enrolled participants is required for tasks related to e.g. sponsor quality management and KPIs. A registry for clinical trials can answer these questions and enhance the exchange of information. METHODS: Requirements for an in-house registry for clinical trials were defined in a multidisciplinary task force. The requirements included interfaces and key abilities to create customized reports to fulfill the obligation to provide evidence. RESULTS: The study registry is productive since May 2020 and internal interfaces have been implemented to ensure consistency between 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.

Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung - Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023.

In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.

A novel method for a multi-level hierarchical composite with brick-and-mortar structure.

The fascination for hierarchically structured hard tissues such as enamel or nacre arises from their unique structure-properties-relationship. During the last decades this numerously motivated the synthesis of composites, mimicking the brick-and-mortar structure of nacre. However, there is still a lack in synthetic engineering materials displaying a true hierarchical structure. Here, we present a novel multi-step processing route for anisotropic 2-level hierarchical composites by combining different coating techniques on different length scales. It comprises polymer-encapsulated ceramic particles as building blocks for the first level, followed by spouted bed spray granulation for a second level, and finally directional hot pressing to anisotropically consolidate the composite. The microstructure achieved reveals a brick-and-mortar hierarchical structure with distinct, however not yet optimized mechanical properties on each level. It opens up a completely new processing route for the synthesis of multi-level hierarchically structured composites, giving prospects to multi-functional structure-properties relationships.