{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T01:03:59Z","timestamp":1790039039989,"version":"4.0.1"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2015,12,18]],"date-time":"2015-12-18T00:00:00Z","timestamp":1450396800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2015,12,18]],"date-time":"2015-12-18T00:00:00Z","timestamp":1450396800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Biomed Semant"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The specification of metadata in clinical and epidemiological study projects absorbs significant expense. The validity and quality of the collected data depend heavily on the precise and semantical correct representation of their metadata.<\/jats:p>\n                    <jats:p>In various research organizations, which are planning and coordinating studies, the required metadata are specified differently, depending on many conditions, e.g., on the used study management software. The latter does not always meet the needs of a particular research organization, e.g., with respect to the relevant metadata attributes and structuring possibilities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The objective of the research, set forth in this paper, is the development of a new approach for ontology-based representation and management of metadata. The basic features of this approach are demonstrated by the software tool OntoStudyEdit (OSE). The OSE is designed and developed according to the three ontology method. This method for developing software is based on the interactions of three different kinds of ontologies: a task ontology, a domain ontology and a top-level ontology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The OSE can be easily adapted to different requirements, and it supports an ontologically founded representation and efficient management of metadata. The metadata specifications can by imported from various sources; they can be edited with the OSE, and they can be exported in\/to several formats, which are used, e.g., by different study management software.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Advantages of this approach are the adaptability of the OSE by integrating suitable domain ontologies, the ontological specification of mappings between the import\/export formats and the DO, the specification of the study metadata in a uniform manner and its reuse in different research projects, and an intuitive data entry for non-expert users.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13326-015-0042-0","type":"journal-article","created":{"date-parts":[[2015,12,18]],"date-time":"2015-12-18T04:51:54Z","timestamp":1450414314000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["OntoStudyEdit: a new approach for ontology-based representation and management of metadata in clinical and epidemiological research"],"prefix":"10.1186","volume":"6","author":[{"given":"Alexandr","family":"Uciteli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heinrich","family":"Herre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2015,12,18]]},"reference":[{"key":"42_CR1","unstructured":"OpenClinica | Clinical Trial Software for Electronic Data Capture [https:\/\/www.openclinica.com\/]. Accessed 16.12.2015."},{"key":"42_CR2","unstructured":"ERT | Patient Safety and Efficacy Data Collection Solutions for Clinical Research and Healthcare [https:\/\/www.ert.com\/]. Accessed 16.12.2015."},{"key":"42_CR3","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1007\/978-90-481-8847-5_14","volume-title":"Theory and Applications of Ontology: Computer Applications","author":"H Herre","year":"2010","unstructured":"Herre H. General Formal Ontology (GFO): A Foundational Ontology for Conceptual Modelling. In: Poli R, Healy M, Kameas A, editors. Theory and Applications of Ontology: Computer Applications. Netherlands: Springer; 2010. p. 297\u2013345."},{"issue":"Suppl 4","key":"42_CR4","doi-asserted-by":"publisher","first-page":"S1","DOI":"10.1186\/2041-1480-2-S4-S1","volume":"2","author":"A Uciteli","year":"2011","unstructured":"Uciteli A, Gro\u00df S, Kireyev S, Herre H. An ontologically founded architecture for information systems in clinical and epidemiological research. J Biomed Sem. 2011;2 Suppl 4:S1.","journal-title":"J Biomed Sem"},{"key":"42_CR5","unstructured":"Protege-Frames [http:\/\/protegewiki.stanford.edu\/wiki\/Protege-Frames]. Accessed 16.12.2015."},{"key":"42_CR6","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1007\/3-540-39967-4_2","volume-title":"Knowledge Engineering and Knowledge Management Methods, Models, and Tools: 12th International Conference, EKAW 2000 Juan-les-Pins, France, October 2\u20136, 2000 Proceedings. Volume 1937","author":"NF Noy","year":"2000","unstructured":"Noy NF, Fergerson RW, Musen MA. The Knowledge Model of Prot\u00e9g\u00e9-2000: Combining Interoperability and Flexibility. In: Dieng R, Corby O, editors. Knowledge Engineering and Knowledge Management Methods, Models, and Tools: 12th International Conference, EKAW 2000 Juan-les-Pins, France, October 2\u20136, 2000 Proceedings. Volume 1937. Berlin Heidelberg: Springer; 2000. p. 17\u201332 [Lecture Notes in Computer Science]."},{"key":"42_CR7","unstructured":"UML Unified Modeling Language [http:\/\/www.omg.org\/spec\/UML\/]. Accessed 16.12.2015."},{"key":"42_CR8","unstructured":"OWL 2 Web Ontology Language [http:\/\/www.w3.org\/TR\/owl2-overview\/]. Accessed 16.12.2015."},{"key":"42_CR9","doi-asserted-by":"crossref","unstructured":"Hoehndorf R, Ngomo A-CN, Herre H: Developing Consistent and Modular Software Models with Ontologies. In New Trends in Software Methodologies, Tools and Techniques: Proceedings of the Eighth SoMeT_09. Volume 199. Edited by Fujita H, Marik V. Amsterdam: IOS Press; 2009:399\u2013412. [Frontiers in Artificial Intelligence and Applications]","DOI":"10.3233\/978-1-60750-049-0-399"},{"key":"42_CR10","unstructured":"Clinical Trial Centre Leipzig [http:\/\/www.zks.uni-leipzig.de\/]. Accessed 16.12.2015."},{"key":"42_CR11","unstructured":"ODM Operational Data Model | CDISC [http:\/\/www.cdisc.org\/odm]. Accessed 16.12.2015."},{"key":"42_CR12","unstructured":"IFOMIS: ACGT Master Ontology [http:\/\/www.uni-saarland.de\/institut\/ifomis\/activities\/acgt-master-ontology.html]. Accessed 16.12.2015."},{"key":"42_CR13","unstructured":"Logical Observation Identifiers Names and Codes (LOINC\u00ae) \u2014 LOINC [http:\/\/loinc.org\/]. Accessed 16.12.2015."},{"key":"42_CR14","unstructured":"Human Phenotype Ontology [http:\/\/www.human-phenotype-ontology.org\/]. Accessed 16.12.2015."},{"key":"42_CR15","first-page":"1479","volume-title":"Informatik 2009: Im Focus das Leben: GI 2009, L\u00fcbeck, 28.9.-2.10.2009. Proceedings. Volume P-154","author":"M L\u00f6be","year":"2009","unstructured":"L\u00f6be M, Strotmann B, Hoop K-U, M\u00fccke R. A Knowledge-Based System for the Specification of Variables in Clinical Trials. In: Fischer S, Maehle E, Reischuk R, editors. Informatik 2009: Im Focus das Leben: GI 2009, L\u00fcbeck, 28.9.-2.10.2009. Proceedings. Volume P-154. Bonn: K\u00f6llen Druck+Verlag; 2009. p. 1479\u201386 [Lecture Notes in Informatics]."},{"issue":"Pt 2","key":"42_CR16","first-page":"1090","volume":"160","author":"H Stenzhorn","year":"2010","unstructured":"Stenzhorn H, Weiler G, Brochhausen M, Schera F, Kritsotakis V, Tsiknakis M, et al. The ObTiMA system - ontology-based managing of clinical trials. Stud Health Technol Inform. 2010;160(Pt 2):1090\u20134.","journal-title":"Stud Health Technol Inform"},{"key":"42_CR17","first-page":"109","volume-title":"Workshop on Data Management for Life Sciences (DMforLS) - BTW 2015, Hamburg - GI Edition Proceedings LNI. Volume P-242","author":"A Uciteli","year":"2015","unstructured":"Uciteli A, Kirsten T. Ontology-based Retrieval of Scientific Data in LIFE. In: Ritter N, Henrich A, Lehner W, Thor A, Friedrich S, Wingerath W, editors. Workshop on Data Management for Life Sciences (DMforLS) - BTW 2015, Hamburg - GI Edition Proceedings LNI. Volume P-242. Bonn: K\u00f6llen; 2015. p. 109\u201315 [Lecture Notes in Informatics]."}],"container-title":["Journal of Biomedical Semantics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13326-015-0042-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13326-015-0042-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13326-015-0042-0","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13326-015-0042-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:20:46Z","timestamp":1790036446000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13326-015-0042-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,12,18]]},"references-count":17,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2015,12]]}},"alternative-id":["42"],"URL":"https:\/\/doi.org\/10.1186\/s13326-015-0042-0","relation":{},"ISSN":["2041-1480"],"issn-type":[{"value":"2041-1480","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,12,18]]},"assertion":[{"value":"24 March 2015","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 December 2015","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 December 2015","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}],"article-number":"41"}}