gms | German Medical Science

Introduction: The NFDI4Health Task Force COVID-19 “pursues the overarching goal of strengthening harmonized, cooperative medical, epidemiological, and public health” research on COVID-19 [1]. The Study Hub developed in the project should enable the search for COVID-19 health-related studies and associated study documents – such as study protocols or data dictionaries and instruments like questionnaires – informing specialists community about relevant research activities and creating a basis for public data sharing following the FAIR principles [2], [3]. The requirements for the content of the Study Hub are outlined in the publication policy (PP) which will be presented at the conference.

State of the Art: Although there is no consensus on the type and amount of information to make data collected in health-related studies FAIR, there is a general agreement that a comprehensive metadata set with information about context and accessibility of data is an essential requirement [4], [5]. Additionally, documents and templates of instruments on which the studies are based are usually not released, although they should be considered a part of the published data package [6], [7] and an inherently consistent form of research data [8]. Even when the metadata are published, the documents themselves are often not publicly available [6].

Concept: The Study Hub aims to implement an open-access model to its resources to the extent possible. Due to the patient privacy rights regulations, individual participant data are excluded from the scope of the Study Hub and the PP focuses on the resources that do not contain sensitive information.

Implementation: First, the PP defines types of resources that can be published on the Study Hub: (1) a study description represented as a metadata set and (2) study documents supported by metadata. A list of relevant study documents was determined based on the review process focusing on their typicality and content by study providers, who are project partners. Second, a metadata schema was integrated into the PP [3]. The third part of the PP concentrates on formal requirements to study documents to facilitate their reusability. By selection of file formats, the preference was given to machine-readable and -actionable non-proprietary ones. To address copyright issues, the PP also refers to the need to establish a licence. Finally, it is noted that a persistent identifier, namely the Digital Object Identifier (DOI), can be assigned to all types of resources.

Lessons Learned: By obtaining content from actual studies, it was found that not all requirements outlined in the PP could yet be met and additional guidance was preferred, for example, when it came to publishing and licensing study documents. Also, the formats of the published documents were not always machine-readable and non-proprietary, so the initial list of accepted formats has been extended. There are also plans to revise the levels of granularity for DOI assignment to meet community needs. The NFDI4Health Task Force COVID-19 is thus contributing to the creation and dissemination of a clearer framework for public data sharing and is beginning to build user-friendly and community-oriented advisory and infrastructure services.

The authors declare that they have no competing interests.

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