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. 2024 Aug;33(8):e5871.
doi: 10.1002/pds.5871.

Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe

Romin Pajouheshnia  1   2 , Rosa Gini  3 , Lia Gutierrez  2 , Morris A Swertz  4 , Eleanor Hyde  4 , Miriam Sturkenboom  5 , Alejandro Arana  2 , Carla Franzoni  2 , Vera Ehrenstein  6 , Giuseppe Roberto  3 , Miguel Gil  7 , Miguel Angel Maciá  7 , Wiebke Schäfer  8 , Ulrike Haug  8   9 , Nicolas H Thurin  10 , Régis Lassalle  10 , Cécile Droz-Perroteau  10 , Silvia Zaccagnino  11 , Maria Paula Busto  11 , Bas Middelkoop  11 , Karin Gembert  12 , Francisco Sanchez-Saez  13 , Clara Rodriguez-Bernal  13 , Gabriel Sanfélix-Gimeno  13 , Isabel Hurtado  13 , Manuel Barreiro-de Acosta  14 , Beatriz Poblador-Plou  15 , Jonás Carmona-Pírez  15   16 , Antonio Gimeno-Miguel  15 , Alexandra Prados-Torres  15 , Anna Schultze  17 , Ella Jansen  18 , Ron Herings  18 , Josine Kuiper  18 , Igor Locatelli  19 , Janja Jazbar  19 , Špela Žerovnik  19 , Mitja Kos  19 , Steven Smit  20 , Sirje Lind  20 , Andres Metspalu  20 , Stefania Simou  21 , Karin Hedenmalm  21 , Ana Cochino  21 , Paolo Alcini  21 , Xavier Kurz  21 , Susana Perez-Gutthann  2
Affiliations

Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe

Romin Pajouheshnia et al. Pharmacoepidemiol Drug Saf. 2024 Aug.

Abstract

Purpose: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct.

Methods: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe.

Results: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype.

Conclusions: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.

Keywords: FAIR; catalogue; metadata; observational studies; real‐world data sources; reproducibility.

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References

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