Rollout of the NFDI4Health Local Data Hubs - First Results from Call 2024/25

One of the key objectives of NFDI4Health is to ensure the findability of clinical research data and projects. In addition to the central register of NFDI4Health, the German Central Health Study Hub (HSH), the concept also provides for the use of Local Data Hubs (LDH). LDHs are decentralised research data management systems that are operated by the data-holding or-ganisations themselves, but exchange data that is interoperable with the HSH. This report describes the first phase of LDH implementation in nine Data Holding Organisations (DHO). The objective of this phase is to gather additional feedback and implement refinements to the system. Methods: The LDH is based on the open-source system FAIRDOM SEEK [1]. The web-based software is characterised by its ease of use and enables direct publication in the HSH. The LDH and HSH utilise a unified, coordinated metadata schema (MDS) for clinical and epi-demiological studies [2]. As an RDM system, the LDH facilitates the mapping of the research context (people, publications, programmes) and enables the configuration of access rights for all stored resources, including metadata, data and documents, with finely grained permissions [3]. The service is now fully operational. Roll-out phase and call for tenders: Despite the absence of a licensing fee and the modest technical resources required, the DHOs will invariably be charged with the management of the RDM system's content. This responsibility encompasses the preparation of content, particular-ly for the MDS, and the editorial maintenance of content and access management. To facilitate this, it is imperative that workflows within institutions are adapted [4]. The technical resources needed for operation are minimal, and software containers facilitate a relatively uncomplicated installation process. However, to ensure a smooth integration of the IT system into the facili-ties, we have offered temporary hosting (SaaS/software as a service). NFDI4Health has is-sued a limited call for tenders as an additional incentive for efforts to adopt the system early on. Results: Twelve respondents were assessed, nine of whom were granted funding. The selec-tion criteria encompassed the applicants' stated motivations and the continued utilisation of the systems. Six of the nine institutions elected to utilise the hosting offer, while three opted to operate the system autonomously. All institutions have provided at least six study projects ready for publication for the HSH. In addition to implementing the minimum requirements of the MDS, the HSH team successfully conducted quality control. Continuous feedback was collected from the participants. A final discussion was held with all participants. All institutions have expressed a desire to continue utilising the system, and the SaaS users have advocated for the extension of the hosting offer. Discussion and outlook: Contrary to our initial anticipations, which pertained to the involve-ment of the designated community (namely, epidemiological and clinical study centres, cohort studies), smaller institutions and the data integration centres of universities have demonstrated a more pronounced level of engagement. A second wave of applications is currently under-way, which also addresses partners from other consortia.