ODM Clinical Data Generator: Syntactically Correct Clinical Data Based on Metadata Definition.
The Operational Data Model (ODM) is a data standard for interchanging clinical trial data. ODM contains the metadata definition of a study, i.e., case report forms, as well as the clinical data, i.e., the answers of the participants. The portal of medical data models is an infrastructure for creatio...
| Publicado en: | Studies in Health Technology & Informatics no. 278; pp. 35 - 41 |
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| Autores principales: | , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=150565624&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 150565624 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09269630 U1V jtl: Studies in Health Technology & Informatics issn: 09269630 maglogo: N pubinfo: dt: 2021 iid: 278 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 150565624 150565624 150565624 10.3233/SHTI210048 150565624 ppf: 35 ppct: 6 formats: tig: atl: ODM Clinical Data Generator: Syntactically Correct Clinical Data Based on Metadata Definition. aug: au: BRIX, Tobias J. BECKER, Ludger HARBICH, Timm OEHM, Johannes FECHNER, Maximilian DUGAS, Martin STORCK, Michael affil: Institute of Medical Informatics, University of Münster, Germany sug: subj: Metadata Electronic Health Records Health Information Systems Data Security Data Analysis, Statistical Data Collection Privacy and Confidentiality ab: The Operational Data Model (ODM) is a data standard for interchanging clinical trial data. ODM contains the metadata definition of a study, i.e., case report forms, as well as the clinical data, i.e., the answers of the participants. The portal of medical data models is an infrastructure for creation, exchange, and analysis of medical metadata models. There, over 23000 metadata definitions can be downloaded in ODM format. Due to data protection law and privacy issues, clinical data is not contained in these files. Access to exemplary clinical test data in the desired metadata definition is necessary in order to evaluate systems claiming to support ODM or to evaluate if a planned statistical analysis can be performed with the defined data types. In this work, we present a web application, which generates syntactically correct clinical data in ODM format based on an uploaded ODM metadata definition. Data types and range constraints are taken into account. Data for up to one million participants can be generated in a reasonable amount of time. Thus, in combination with the portal of medical data models, a large number of ODM files including metadata definition and clinical data can be provided for testing of any ODM supporting system. The current version of the application can be tested at https://cdgen.uni-muenster.de and source code is available, under MIT license, at https://imigitlab.uni-muenster.de/published/odm-clinical-data-generator. pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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