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 study, i.e., case report forms, as well data, answers participants. portal medical models an infrastructure creation, exchange, and analysis models. There, over 23000 definitions can be downloaded in format. Due to protection law privacy issues, not contained these files. Access exemplary test desired necessary order evaluate systems claiming support or if planned statistical performed with defined types. In this work, we present web application, which generates syntactically correct format based on uploaded definition. types range constraints are taken into account. up one million participants generated reasonable amount time. Thus, combination models, large number files including provided testing any supporting system. current version application tested at https://cdgen.uni-muenster.de source code available, under MIT license, https://imigitlab.uni-muenster.de/published/odm-clinical-data-generator.