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. 2024 Aug;33(8):e5884.
doi: 10.1002/pds.5884.

Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Rosa Gini  1 , Romin Pajouheshnia  2   3 , Lia Gutierrez  3 , Morris A Swertz  4 , Eleanor Hyde  4 , Miriam Sturkenboom  5 , Alejandro Arana  3 , Carla Franzoni  3 , Vera Ehrenstein  6 , Giuseppe Roberto  1 , 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  3
Affiliations

Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Rosa Gini et al. Pharmacoepidemiol Drug Saf. 2024 Aug.
No abstract available

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

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References

    1. M. Wilkinson, M. Dumontier, I. Aalbersberg, et al., “The FAIR Guiding Principles for Scientific Data Management and Stewardship,” Scientific Data 15, no. 3 (2016): 160018, https://doi.org/10.1038/sdata.2016.18.
    1. HMA–EMA, “Priority Recommendations of the HMA‐EMA Joint big Data Task Force,” HMA‐EMA Big Data Steering Committee Group, accessed May 14, 2024, https://www.ema.europa.eu/en/documents/other/priority‐recommendations‐hm....
    1. HMA–EMA, “Big Data Steering Group. Workplan,” accessed May 14, 2024, https://www.hma.eu/fileadmin/dateien/HMA_joint/00‐_About_HMA/03‐Working_....
    1. R. Pajouheshnia, R. Gini, L. Gutierrez, et al., “Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies: Definition and Recommendations of Use From the MINERVA Project in Europe,” Pharmacoepidemiology and Drug Safety (2024), https://doi.org/10.1002/pds.5871.
    1. European Medicines Agency, “Good Practice Guide for the Use of the Metadata Catalogue of Real‐World Data Sources V 1.0,” accessed December 19, 2023, https://www.ema.europa.eu/en/documents/regulatory‐procedural‐guideline/g....

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