the MINERVA (Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies) project (EUPAS39322) was initiated in response to the HMA–EMA joint Big Data Task Force recommendation on “the identification of metadata” for regulatory decision-making on the choice of data source. The MINERVA Consortium included 18 institutions and worked in collaboration with the EMA. MOLGENIS co-lead the metadata model definition and lead the pilot implementation for HMA-EMA Catalogues of real-world data sources and studies. This project was funded by the European Medicines Agency (EMA) through the framework contract No. EMA/2017/09/PE/16.