Metadata for data dIscoverability aNd study rEplicability in obseRVAtional Studies (MINERVA) : development and pilot of a metadata list and catalogue in Europe

Pajouheshnia, Romin (author), Gini, Rosa (author), Gutierrez, Lia (author), Swertz, Morris A. (author), Hyde, Eleanor (author), Sturkenboom, Miriam C. (author), Arana, Alejandro (author), Franzoni, Carla (author), Locatelli, Igor (author), Jazbar, Janja (author), Žerovnik, Špela (author), Kos, Mitja (author)

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.

• Language: English
• Keywords: metadata
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2024
• Number of pages: 12 str.
• Numbering: Vol. 33, iss. 8, e5871
• PID: 20.500.12556/RUL-160098
• UDC: 001.103.2
• ISSN on article: 1053-8569
• DOI: 10.1002/pds.5871
• COBISS.SI-ID: 204502019
• Publication date in RUL: 20.08.2024

Record is a part of a journal

• Title: Pharmacoepidemiology and drug safety
• Shortened title: Pharmacoepidemiol. drug saf.
• Publisher: Wiley
• ISSN: 1053-8569
• COBISS.SI-ID: 1515540

Licences

• License: CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nc-nd/4.0/
• Description: The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

Secondary language

• Language: Slovenian
• Keywords: metapodatki

Projects

• Funder: Other - Other funder or multiple funders
• Funding programme: European Medicines Agency
• Project number: EMA/2017/09/PE/16