Brix Tobias J, Becker Ludger, Harbich Timm, Oehm Johannes, Fechner Maximilian, Dugas Martin, Storck Michael
Institute of Medical Informatics, University of Münster, Germany.
Institute of Computer Science, University of Münster, Germany.
Stud Health Technol Inform. 2021 May 24;278:35-40. doi: 10.3233/SHTI210048.
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.
操作数据模型（ODM）是一种用于交换临床试验数据的数据标准。ODM包含研究的元数据定义，即病例报告表，以及临床数据，即参与者的答案。医学数据模型门户是用于创建、交换和分析医学元数据模型的基础设施。在那里，可以以ODM格式下载超过23000个元数据定义。由于数据保护法和隐私问题，这些文件中不包含临床数据。为了评估声称支持ODM的系统，或者评估是否可以使用定义的数据类型进行计划的统计分析，需要访问具有所需元数据定义的示例性临床试验数据。在这项工作中，我们展示了一个Web应用程序，它基于上传的ODM元数据定义生成符合语法的ODM格式临床数据。会考虑数据类型和范围约束。可以在合理的时间内生成多达一百万名参与者的数据。因此，结合医学数据模型门户，可以提供大量包括元数据定义和临床数据的ODM文件，用于测试任何支持ODM的系统。该应用程序的当前版本可以在https://cdgen.uni-muenster.de进行测试，并且根据MIT许可，源代码可在https://imigitlab.uni-muenster.de/published/odm-clinical-data-generator获取。
