Mah, Nancy LynneNancy LynneMahMayrhofer, MichaelaMichaelaMayrhoferKozlakidis, ZisisZisisKozlakidisJongerius, JolienJolienJongerius2025-02-052025-02-052024-11-17https://publica.fraunhofer.de/handle/publica/48364610.5281/zenodo.14176680This document describes guidelines for assessing large medical cohorts (LMedC) for their suitability to be included in a future research infrastructure (RI). These guidelines will take into account ethical, legal and societal issues (ELSI), as well as the FAIR guidelines for responsible scientific data management. The present document is the first version of the assessment regime and is considered a working document, which will be updated and refined as INTEGRATE LMedC progresses.enreport