Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe-Reference-Cited by-同舟云学术

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

Published:2024-08 Issue:8 Volume:33 Page:
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Gini Rosa¹^ORCID,Pajouheshnia Romin²³^ORCID,Gutierrez Lia³^ORCID,Swertz Morris A.⁴^ORCID,Hyde Eleanor⁴^ORCID,Sturkenboom Miriam⁵^ORCID,Arana Alejandro³^ORCID,Franzoni Carla³^ORCID,Ehrenstein Vera⁶^ORCID,Roberto Giuseppe¹^ORCID,Gil Miguel⁷^ORCID,Maciá Miguel Angel⁷^ORCID,Schäfer Wiebke⁸^ORCID,Haug Ulrike⁸⁹^ORCID,Thurin Nicolas H.¹⁰^ORCID,Lassalle Régis¹⁰^ORCID,Droz‐Perroteau Cécile¹⁰^ORCID,Zaccagnino Silvia¹¹^ORCID,Busto Maria Paula¹¹^ORCID,Middelkoop Bas¹¹,Gembert Karin¹²^ORCID,Sanchez‐Saez Francisco¹³^ORCID,Rodriguez‐Bernal Clara¹³^ORCID,Sanfélix‐Gimeno Gabriel¹³^ORCID,Hurtado Isabel¹³^ORCID,Acosta Manuel Barreiro‐de¹⁴^ORCID,Poblador‐Plou Beatriz¹⁵^ORCID,Carmona‐Pírez Jonás¹⁵¹⁶^ORCID,Gimeno‐Miguel Antonio¹⁵^ORCID,Prados‐Torres Alexandra¹⁵^ORCID,Schultze Anna¹⁷^ORCID,Jansen Ella¹⁸^ORCID,Herings Ron¹⁸^ORCID,Kuiper Josine¹⁸^ORCID,Locatelli Igor¹⁹^ORCID,Jazbar Janja¹⁹^ORCID,Žerovnik Špela¹⁹^ORCID,Kos Mitja¹⁹^ORCID,Smit Steven²⁰^ORCID,Lind Sirje²⁰,Metspalu Andres²⁰^ORCID,Simou Stefania²¹,Hedenmalm Karin²¹^ORCID,Cochino Ana²¹^ORCID,Alcini Paolo²¹,Kurz Xavier²¹^ORCID,Perez‐Gutthann Susana³^ORCID

Affiliation:

1. Agenzia Regionale di Sanità Della Toscana Florence Italy

2. Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht University Utrecht The Netherlands

3. Department of Epidemiology RTI Health Solutions Barcelona Spain

4. Department of Genetics University Medical Centre Groningen Groningen The Netherlands

5. Department of Datascience and Biostatistics University Medical Centre Utrecht Utrecht The Netherlands

6. Department of Clinical Epidemiology Aarhus University and Aarhus University Hospital Aarhus Denmark

7. Base de Datos Para la Investigación Farmacoepidemiológica en Atención Primaria Agencia Española de Medicamentos y Productos Sanitarios Madrid Spain

8. Department of Clinical Epidemiology Leibniz Institute for Prevention Research and Epidemiology Bremen Germany

9. Faculty of Human and Health Science University of Bremen Bremen Germany

10. Bordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux France

11. European Society for Blood & Marrow Transplantation Leiden The Netherlands

12. Department of Epidemiology Karolinska Institutet Stockholm Sweden

13. Health Services Research & Pharmacoepidemiology Unit Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain

14. Spanish Working Group on Crohn's Disease and Ulcerative Colitis Bilbao Spain

15. EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital Zaragoza Spain

16. Technical Advisory Subdirectorate of Information Management (STAGI) Andalusian Health Service (SAS) Seville Spain

17. Faculty of Epidemiology and Population Health London School of Hygiene and Tropical Medicine London UK

18. PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands

19. University of Ljubljana Faculty of Pharmacy Ljubljana Slovenia

20. Estonian Genome Centre Institute of Genomics, University of Tartu Tartu Estonia

21. European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5884

Reference17 articles.

1. The FAIR Guiding Principles for scientific data management and stewardship

2. 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‐hma‐ema‐joint‐big‐data‐task‐force_en.pdf.

3. HMA–EMA “Big Data Steering Group. Workplan ” accessed May 14 2024 https://www.hma.eu/fileadmin/dateien/HMA_joint/00‐_About_HMA/03‐Working_Groups/Big_Data/2020_09_HMA‐EMA_Big_Data_SG_Workplan.pdf.

4. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies: Definition and Recommendations of Use From the MINERVA Project in Europe;Pajouheshnia R.;Pharmacoepidemiology and Drug Safety,2024

5. 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/good‐practice‐guide‐use‐metadata‐catalogue‐real‐world‐data‐sources_en.pdf.

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