gms | German Medical Science

Epidemiological and clinical studies are standardized and well documented. While entry in clinical trial registries is mandatory for clinical trials, this is not required for epidemiological and public health studies. In addition, study documents like survey instruments and data catalogs for a certain study are often not published, and the possibilities of data re-use by third parties are usually limited.

One aim of the National Research Data Infrastructure for Personalized Health Data (NFDI4Health) is to mitigate the above problems by increasing the FAIRness – Findability, Accessibility, Interoperability and Re-usability – of clinical, epidemiological and public health studies conducted in Germany. NFDI4Health aims to increase findability through an easy-to-use, harmonized search and exploration platform. The German Central Health Study Hub COVID-19 (https://covid19.studyhub.nfdi4health.de), developed by the Task Force COVID-19, is such a service and currently bundles over 1,000 (Apr. 2022) epidemiological, public health, and clinical studies into a single data repository. In addition to study characteristics, the platform also provides easy access to survey instruments.

The data model for the study hub was developed to capture and harmonize information from different study types and is able to describe hierarchies, especially between studies and associated documents [1]. The model is based on attributes used by established registers like clinicaltrails.gov [1], DRKS [2], and WHO ICTRP [3]. In addition, the required properties for assigning Digital Object Identifiers (DOIs) have been added by adhering to the DataCite scheme [4]. These properties allow associated documents such as questionnaires, data dictionaries, and eCRFs to be individually referenced. Currently, the metadata model is tested by different NFDI4Health use cases and with external partners in order to agree on a minimal metadata standard to describe studies and study-related documents.

The study hub currently re-uses data from other sources (see above). We are planning to integrate further data sources like EUDRACT [5] and Medical Data Model (MDM) [6] portal. We collaborate with the MDM portal group to exchange data between both platforms. Furthermore, we have also started exchange with the data management working group of the German Centres for Health Research to allow for automatic upload of metadata and associated documents from their platforms. In order to enhance our content on epidemiological and public health studies, that are not yet registered, we established a publication guideline [7]. In addition, data stewards actively retrieve metadata from public resources, offer training and help data owners to publish study characteristics, metadata and study related documents.

The NFDI4Health study hub is constantly improved and will be extended to further data collections in the near future. In addition, we will set up a central access portal to broker access to the data hosted by distributed infrastructures. For defined use cases, a distributed data analytics infrastructure is currently set up to allow for combined analysis of distributed data in compliance with data protection regulations.

This paper is presented on behalf of the NFDI4Health and NFDI4Health Task Force COVID-19 partners (https://www.nfdi4health.de). We thank the German Research Foundation (DFG) for financial support – project numbers 451265285 and 442326535.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.