{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T12:03:52Z","timestamp":1786363432245,"version":"build-2736575974"},"reference-count":41,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,8,15]],"date-time":"2024-08-15T00:00:00Z","timestamp":1723680000000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","award":["EMA\/2017\/09\/PE\/16"],"award-info":[{"award-number":["EMA\/2017\/09\/PE\/16"]}],"id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,8]]},"abstract":"ABSTRACT<\/jats:title>Purpose<\/jats:title>Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency\u2013funded project (EUPAS39322), defined a set of metadata to describe real\u2010world data sources (RWDSs) and piloted metadata collection in a prototype<\/jats:italic> catalogue to assist investigators from data source discoverability through study conduct.<\/jats:p><\/jats:sec>Methods<\/jats:title>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.<\/jats:p><\/jats:sec>Results<\/jats:title>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.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5871","type":"journal-article","created":{"date-parts":[[2024,8,15]],"date-time":"2024-08-15T09:14:32Z","timestamp":1723713272000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4208-3583","authenticated-orcid":false,"given":"Romin","family":"Pajouheshnia","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht University Utrecht The Netherlands"},{"name":"Department of Epidemiology RTI Health Solutions Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6250-877X","authenticated-orcid":false,"given":"Rosa","family":"Gini","sequence":"additional","affiliation":[{"name":"Agenzia Regionale di Sanit\u00e0 della Toscana Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6280-1119","authenticated-orcid":false,"given":"Lia","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Department of Epidemiology RTI Health Solutions Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0979-3401","authenticated-orcid":false,"given":"Morris\u00a0A.","family":"Swertz","sequence":"additional","affiliation":[{"name":"Department of Genetics University Medical Centre Groningen Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2744-0017","authenticated-orcid":false,"given":"Eleanor","family":"Hyde","sequence":"additional","affiliation":[{"name":"Department of Genetics University Medical Centre Groningen Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1360-2388","authenticated-orcid":false,"given":"Miriam","family":"Sturkenboom","sequence":"additional","affiliation":[{"name":"University Medical Centre Utrecht Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1593-3124","authenticated-orcid":false,"given":"Alejandro","family":"Arana","sequence":"additional","affiliation":[{"name":"Department of Epidemiology RTI Health Solutions Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8856-071X","authenticated-orcid":false,"given":"Carla","family":"Franzoni","sequence":"additional","affiliation":[{"name":"Department of Epidemiology RTI Health Solutions Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3415-3254","authenticated-orcid":false,"given":"Vera","family":"Ehrenstein","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology Aarhus University and Aarhus University Hospital Aarhus Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6478-6442","authenticated-orcid":false,"given":"Giuseppe","family":"Roberto","sequence":"additional","affiliation":[{"name":"Agenzia Regionale di Sanit\u00e0 della Toscana Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3827-9564","authenticated-orcid":false,"given":"Miguel","family":"Gil","sequence":"additional","affiliation":[{"name":"Base de datos para la Investigaci\u00f3n Farmacoepidemiol\u00f3gica en Atenci\u00f3n Primaria Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1471-4376","authenticated-orcid":false,"given":"Miguel\u00a0Angel","family":"Maci\u00e1","sequence":"additional","affiliation":[{"name":"Base de datos para la Investigaci\u00f3n Farmacoepidemiol\u00f3gica en Atenci\u00f3n Primaria Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8284-448X","authenticated-orcid":false,"given":"Wiebke","family":"Sch\u00e4fer","sequence":"additional","affiliation":[{"name":"Leibniz Institute for Prevention Research and Epidemiology Bremen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1886-2923","authenticated-orcid":false,"given":"Ulrike","family":"Haug","sequence":"additional","affiliation":[{"name":"Leibniz Institute for Prevention Research and Epidemiology Bremen Germany"},{"name":"Faculty of Human and Health Science University of Bremen Bremen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3589-0819","authenticated-orcid":false,"given":"Nicolas\u00a0H.","family":"Thurin","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi INSERM CIC\u2010P 1401 Universit\u00e9 de Bordeaux Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6726-6215","authenticated-orcid":false,"given":"R\u00e9gis","family":"Lassalle","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi INSERM CIC\u2010P 1401 Universit\u00e9 de Bordeaux Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7697-1167","authenticated-orcid":false,"given":"C\u00e9cile","family":"Droz\u2010Perroteau","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi INSERM CIC\u2010P 1401 Universit\u00e9 de Bordeaux Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9733-2532","authenticated-orcid":false,"given":"Silvia","family":"Zaccagnino","sequence":"additional","affiliation":[{"name":"European Society for Blood & Marrow Transplantation Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0337-9664","authenticated-orcid":false,"given":"Maria\u00a0Paula","family":"Busto","sequence":"additional","affiliation":[{"name":"European Society for Blood & Marrow Transplantation Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bas","family":"Middelkoop","sequence":"additional","affiliation":[{"name":"European Society for Blood & Marrow Transplantation Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-1577","authenticated-orcid":false,"given":"Karin","family":"Gembert","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Karolinska Institutet Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3011-9884","authenticated-orcid":false,"given":"Francisco","family":"Sanchez\u2010Saez","sequence":"additional","affiliation":[{"name":"Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2617-8635","authenticated-orcid":false,"given":"Clara","family":"Rodriguez\u2010Bernal","sequence":"additional","affiliation":[{"name":"Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7098-4576","authenticated-orcid":false,"given":"Gabriel","family":"Sanf\u00e9lix\u2010Gimeno","sequence":"additional","affiliation":[{"name":"Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8475-8112","authenticated-orcid":false,"given":"Isabel","family":"Hurtado","sequence":"additional","affiliation":[{"name":"Foundation for the Promotion of Health and Biomedical Research of the Valencia Region Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5915-1477","authenticated-orcid":false,"given":"Manuel\u00a0Barreiro\u2010de","family":"Acosta","sequence":"additional","affiliation":[{"name":"Spanish Working Group on Crohn's Disease and Ulcerative Colitis Bilbao Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5119-5093","authenticated-orcid":false,"given":"Beatriz","family":"Poblador\u2010Plou","sequence":"additional","affiliation":[{"name":"EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Arag\u00f3n, Miguel Servet University Hospital Zaragoza Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6268-8803","authenticated-orcid":false,"given":"Jon\u00e1s","family":"Carmona\u2010P\u00edrez","sequence":"additional","affiliation":[{"name":"EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Arag\u00f3n, Miguel Servet University Hospital Zaragoza Spain"},{"name":"Technical Advisory Subdirectorate of Information Management (STAGI) Andalusian Health Service (SAS) Seville Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5440-1710","authenticated-orcid":false,"given":"Antonio","family":"Gimeno\u2010Miguel","sequence":"additional","affiliation":[{"name":"EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Arag\u00f3n, Miguel Servet University Hospital Zaragoza Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5704-6056","authenticated-orcid":false,"given":"Alexandra","family":"Prados\u2010Torres","sequence":"additional","affiliation":[{"name":"EpiChron Research Group Aragon Health Sciences Institute (IACS), IIS Arag\u00f3n, Miguel Servet University Hospital Zaragoza Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1637-837X","authenticated-orcid":false,"given":"Anna","family":"Schultze","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5684-6537","authenticated-orcid":false,"given":"Ella","family":"Jansen","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2561-8734","authenticated-orcid":false,"given":"Ron","family":"Herings","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4487-3546","authenticated-orcid":false,"given":"Josine","family":"Kuiper","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0052-8986","authenticated-orcid":false,"given":"Igor","family":"Locatelli","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5613-9800","authenticated-orcid":false,"given":"Janja","family":"Jazbar","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3918-0929","authenticated-orcid":false,"given":"\u0160pela","family":"\u017derovnik","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6801-6450","authenticated-orcid":false,"given":"Mitja","family":"Kos","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3791-635X","authenticated-orcid":false,"given":"Steven","family":"Smit","sequence":"additional","affiliation":[{"name":"Institute of Genomics, University of Tartu Tartu Estonia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sirje","family":"Lind","sequence":"additional","affiliation":[{"name":"Institute of Genomics, University of Tartu Tartu Estonia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3718-796X","authenticated-orcid":false,"given":"Andres","family":"Metspalu","sequence":"additional","affiliation":[{"name":"Institute of Genomics, University of Tartu Tartu Estonia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Simou","sequence":"additional","affiliation":[{"name":"European Medicines Agency Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9544-9163","authenticated-orcid":false,"given":"Karin","family":"Hedenmalm","sequence":"additional","affiliation":[{"name":"European Medicines Agency Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5962-684X","authenticated-orcid":false,"given":"Ana","family":"Cochino","sequence":"additional","affiliation":[{"name":"European Medicines Agency Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Alcini","sequence":"additional","affiliation":[{"name":"European Medicines Agency Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9838-7754","authenticated-orcid":false,"given":"Xavier","family":"Kurz","sequence":"additional","affiliation":[{"name":"European Medicines Agency Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5798-3691","authenticated-orcid":false,"given":"Susana","family":"Perez\u2010Gutthann","sequence":"additional","affiliation":[{"name":"Department of Epidemiology RTI Health Solutions Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,15]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"X.Kurz \u201cDarwin EU\u2014First Experience and Regulatory Use Cases \u201d Data Analytics and Methods Taskforce European Medicines Agency. EMA\/HMA Big Data Stakeholder Forum 2022 accessed December 15 2022 https:\/\/www.ema.europa.eu\/en\/documents\/presentation\/session\u20102\u20101\u2010darwin\u2010eu\u2010r\u2010first\u2010experiences\u2010regulatory\u2010use\u2010case\u2010xavier\u2010kurz_en.pdf."},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/sdata.2016.18"},{"key":"e_1_2_12_4_1","unstructured":"Heads of Medicines Agencies European Medicines Agency \u201cHMA\u2013EMA Joint Big Data Taskforce Phase II Report: Evolving Data\u2010Driven Regulation \u201d accessed October 11 2022 https:\/\/www.ema.europa.eu\/en\/documents\/other\/hma\u2010ema\u2010joint\u2010big\u2010data\u2010taskforce\u2010phase\u2010ii\u2010report\u2010evolving\u2010data\u2010driven\u2010regulation_en.pdf."},{"key":"e_1_2_12_5_1","unstructured":"Heads of Medicines Agencies European Medicines Agency \u201cPriority Recommendations of the HMA\u2013EMA Joint Big Data Task Force \u201d HMA\u2013EMA Big Data Steering Committee Group accessed January 9 2023 https:\/\/www.ema.europa.eu\/en\/documents\/other\/priority\u2010recommendations\u2010hma\u2010ema\u2010joint\u2010big\u2010data\u2010task\u2010force_en.pdf."},{"key":"e_1_2_12_6_1","unstructured":"Heads of Medicines Agencies European Medicines Agency \u201cBig Data Steering Group \u201d accessed January 9 2023 https:\/\/www.ema.europa.eu\/system\/files\/documents\/work\u2010programme\/workplan\u20102023\u20102025\u2010hmaema\u2010joint\u2010big\u2010data\u2010steering\u2010group_en.pdf."},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-023090"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2476"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1833"},{"key":"e_1_2_12_10_1","unstructured":"European Medicines Agency \u201cCatalogue of RWD Studies \u201d MINERVA Final Set of Metadata and Definitions Process and Catalogue Tool accessed May 2 2024 https:\/\/catalogues.ema.europa.eu\/sites\/default\/files\/document_files\/MINERVA_D5_Report_v1.1_28June2021.pdf."},{"key":"e_1_2_12_11_1","unstructured":"US Food and Drug Administration \u201cFDA's Sentinel Initiative \u201d accessed October 11 2022 https:\/\/www.fda.gov\/safety\/fdas\u2010sentinel\u2010initiative."},{"key":"e_1_2_12_12_1","unstructured":"Cnodes.ca \u201cCNODES | Canadian Network for Observational Drug Effects Studies \u201d accessed October 11 2022 https:\/\/www.cnodes.ca."},{"key":"e_1_2_12_13_1","unstructured":"Ehden.eu \u201cEuropean Health Data Evidence Network \u2013 ehden.eu \u201d accessed October 11 2022 https:\/\/www.ehden.eu\/."},{"key":"e_1_2_12_14_1","unstructured":"Imi\u2010conception.eu \u201cConcePTION \u201d accessed October 11 2022 https:\/\/www.imi\u2010conception.eu\/."},{"key":"e_1_2_12_15_1","unstructured":"Aspennet.asia \u201cAsian Pharmacoepidemiology Network 2021 \u201d accessed October 11 2022 https:\/\/aspennet.asia\/."},{"key":"e_1_2_12_16_1","unstructured":"Fairplus\u2010project.eu \u201cFAIRplus | Home Page \u201d accessed October 11 2022 https:\/\/fairplus\u2010project.eu."},{"key":"e_1_2_12_17_1","unstructured":"Maelstrom\u2010research.org \u201cHome Page | Maelstrom Research \u201d accessed 11 October 2022 https:\/\/www.maelstrom\u2010research.org."},{"key":"e_1_2_12_18_1","unstructured":"Aetion \u201cReal\u2010World Evidence Solution | RWE Analytics | Aetion \u201d accessed October 11 2022 https:\/\/aetion.com."},{"key":"e_1_2_12_19_1","unstructured":"European Medicines Agency \u201cTechnical Workshop on Real\u2010World Metadata for Regulatory Purposes \u201d Virtual Meeting European Medicines Agency accessed January 16 2023 https:\/\/www.ema.europa.eu\/en\/documents\/other\/summary\u2010report\u2010technical\u2010workshop\u2010real\u2010world\u2010metadata\u2010regulatory\u2010purposes_en.pdf."},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2229"},{"key":"e_1_2_12_21_1","unstructured":"European Medicines Agency \u201cCatalogue of RWD Studies. MINERVA Deliverable 2 Selection of Data Sources and Justification: Final \u201d accessed May 2 2024 https:\/\/catalogues.ema.europa.eu\/system\/files\/2024\u201002\/MINERVA_DataSourceSelection_Final_26March2021.pdf."},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/bioinformatics\/bty742"},{"key":"e_1_2_12_23_1","unstructured":"EUCAN\u2010connect \u201cCatalogue \u201d accessed April 24 2023 https:\/\/catalogue.eucanconnect.eu\/#\/."},{"key":"e_1_2_12_24_1","unstructured":"LifeCycle \u201cProject Summary \u201d accessed April 24 2023 https:\/\/lifecycle\u2010project.eu\/about\u2010lifecycle\/project\u2010summary\/."},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/EE9.0000000000000184"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/EE9.0000000000000166"},{"key":"e_1_2_12_27_1","unstructured":"The European Human Exposome Network \u201cHuman Exposome \u201d accessed April 24 2023 www.humanexposome.eu."},{"key":"e_1_2_12_28_1","unstructured":"Data Catalogue Vocabulary (DCAT) \u201cData Catalogue Vocabulary \u2013 Version 2 \u201d accessed April 24 2023 https:\/\/www.w3.org\/TR\/vocab\u2010dcat\u20102\/."},{"key":"e_1_2_12_29_1","unstructured":"GitHub \u201cObservational Medical Outcomes Partnership Common Data Model \u201d accessed January 26 2023 https:\/\/ohdsi.github.io\/CommonDataModel\/."},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-017-4312-5"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-021-00498-3"},{"key":"e_1_2_12_32_1","unstructured":"European Medicines Agency \u201cCatalogue of RWD Studies \u201d MINERVA Deliverable 9 Final Good Practice Guide for Metadata Collection for Real\u2010World Data Sources accessed May 2 2024 https:\/\/catalogues.ema.europa.eu\/sites\/default\/files\/document_files\/MINERVA_GoodPracticeGuide_10Jan2022.pdf."},{"key":"e_1_2_12_33_1","unstructured":"European Commission \u201cEuropean Health Data Space \u201d accessed December 5 2023 https:\/\/health.ec.europa.eu\/ehealth\u2010digital\u2010health\u2010and\u2010care\/european\u2010health\u2010data\u2010space_en."},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5884"},{"key":"e_1_2_12_35_1","unstructured":"European Medicines Agency \u201cList of Metadata for Real World Data Catalogues \u201d accessed November 23 2023 https:\/\/www.ema.europa.eu\/en\/documents\/other\/list\u2010metadata\u2010real\u2010world\u2010data\u2010catalogues_en.pdf."},{"key":"e_1_2_12_36_1","unstructured":"VAC4EU \u201cToolbox Catalogue \u201d accessed December 19 2023 https:\/\/vac4eu.org\/catalogue\/."},{"key":"e_1_2_12_37_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102105\u201011\u2010S12\u2010S12"},{"key":"e_1_2_12_38_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0042-1742522"},{"key":"e_1_2_12_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5787"},{"key":"e_1_2_12_40_1","unstructured":"European Medicines Agency \u201cCatalogue of RWD Studies | HMA\u2013EMA Catalogues of Real\u2010World Data Sources and Studies (europa.eu) \u201d accessed May 2 2024 https:\/\/catalogues.ema.europa.eu\/catalogue\u2010rwd\u2010studies."},{"key":"e_1_2_12_41_1","unstructured":"European Medicines Agency \u201cCatalogue of RWD Sources | HMA\u2013EMA Catalogues of Real\u2010World Data Sources and Studies (europa.eu) \u201d accessed May 2 2024 https:\/\/catalogues.ema.europa.eu\/catalogue\u2010rwd\u2010sources."},{"key":"e_1_2_12_42_1","unstructured":"European Medicines Agency \u201cGood Practice Guide for the use of the Metadata Catalogue of Real\u2010World Data Sources \u201d V 1.0 accessed November 23 2023 https:\/\/www.ema.europa.eu\/en\/documents\/regulatory\u2010procedural\u2010guideline\/good\u2010practice\u2010guide\u2010use\u2010metadata\u2010catalogue\u2010real\u2010world\u2010data\u2010sources_en.pdf."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5871","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T01:51:06Z","timestamp":1732153866000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5871"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":41,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1002\/pds.5871"],"URL":"https:\/\/doi.org\/10.1002\/pds.5871","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]},"assertion":[{"value":"2023-06-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5871"}}