A presentation semantic for the operational data model (ODM)

The Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) is a standard for structural interchange and archiving of clinical trial data. However, ODM insufficiently supports visualization (e.g., dropdown vs. checkbox), layout (e.g., horizontal vs. vertical), and functionality (e.g., hiding of fields). In this work, the Operational Data Representation (ODR) is defined as a semi-formal specification language. ODR extends ODM by a presentation layer, whereby ODM is still used for data binding. As proof of concept, a software framework of ODR rendering engines is implemented on various devices (web, mobile applications, paper-based). A converter for OpenClinica eCRFs is developed to simplify ODR specification. Using ODR, a public repository of more than 4,000 ODM-based eCRFs is rendered correctly on all runtime systems. Therefore, ODR allows eCRF interchange across heterogeneous devices and systems on the visual and the functional level. It will simplify electronic patient-reported outcome (ePRO).