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They are often collected in study databases for research purposes. In order to describe characteristics of a next-generation study database and assess the feasibility of its implementation a proof-of-concept study in a German university hospital was performed. Key characteristics identified include FAIR access to electronic case report forms (eCRF), regulatory compliant Electronic Data Capture (EDC), an EDC with electronic health record (EHR) integration, scalable EDC for medical documentation, patient generated data, and clinical decision support. In a local case study, we then successfully implemented a next-generation study database for 19 EDC systems (<jats:italic>n<\/jats:italic>\u2009=\u20092217 patients) that linked to i.s.h.med (Oracle Cerner) with the local EDC system called OpenEDC. Desiderata of next-generation study databases for patient data were identified from ongoing local clinical study projects in 11 clinical departments at Heidelberg University Hospital, Germany, a major tertiary referral hospital. We compiled and analyzed feature and functionality requests submitted to the OpenEDC team between May 2021 and July 2023. Next-generation study databases are technically and clinically feasible. Further research is needed to evaluate if our approach is feasible in a multi-center setting as well.<\/jats:p>","DOI":"10.1038\/s41746-023-00994-6","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T20:02:28Z","timestamp":1705089748000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support"],"prefix":"10.1038","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9740-0788","authenticated-orcid":false,"given":"Martin","family":"Dugas","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9816-0445","authenticated-orcid":false,"given":"Max","family":"Blumenstock","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6442-8255","authenticated-orcid":false,"given":"Tobias","family":"Dittrich","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8770-3822","authenticated-orcid":false,"given":"Urs","family":"Eisenmann","sequence":"additional","affiliation":[]},{"given":"Stephan Christoph","family":"Feder","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9005-6766","authenticated-orcid":false,"given":"Fleur","family":"Fritz-Kebede","sequence":"additional","affiliation":[]},{"given":"Lucy J.","family":"Kessler","sequence":"additional","affiliation":[]},{"given":"Maximilian","family":"Klass","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1104-0628","authenticated-orcid":false,"given":"Petra","family":"Knaup","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9559-4646","authenticated-orcid":false,"given":"Christoph U.","family":"Lehmann","sequence":"additional","affiliation":[]},{"given":"Angela","family":"Merzweiler","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8887-0996","authenticated-orcid":false,"given":"Christian","family":"Niklas","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6145-3263","authenticated-orcid":false,"given":"Thomas M.","family":"Pausch","sequence":"additional","affiliation":[]},{"given":"Nelly","family":"Zental","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2716-5425","authenticated-orcid":false,"given":"Matthias","family":"Ganzinger","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2024,1,12]]},"reference":[{"key":"994_CR1","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1016\/0197-2456(81)90056-8","volume":"2","author":"TC Chalmers","year":"1981","unstructured":"Chalmers, T. 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No data of individual patients were directly used for this study. Evaluation of the prototype data capture system was approved by the responsible Ethics Committee of the Medical Faculty at Heidelberg University (ethics committee study number: S-607\/2023).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}],"article-number":"10"}}