Fig 1.
Schematic structure of an ODM file.
Hierarchical structure of the ODM’s metadata on the left side and clinical data on the right side. The added attributes should clarify the connection between metadata and clinical data elements.
Table 1.
Table illustrating the five different categories the application distinguishes and their calculated statistics and charts.
Table 2.
Table of dataset characteristics used for the benchmark.
Fig 2.
Schematic overview of the application’s workflow.
The user can upload an ODM file via the web-based front-end. After parsing the file, its content is temporarily stored in a database. The calculated statistics and charts are presented on the result pages and are also generated as PDF. The PDF can be downloaded via the front-end and will be deleted from the server, equally the database content, after the session ends.
Fig 3.
Cover page of the web-application.
The image shows the first page presented to the user after starting ODM-DA. Besides allowing the upload of an ODM file for the analysis, the download of a test file and a link to the user manual are provided. In addition, the different analysis options can be specified.
Fig 4.
Analysis page of the web-application.
Result page after uploading the provided test ODM file. The left navigation bar can be used to select forms from all study events contained in the clinical study data. The selected forms are shown on the right side, where each item group can be expanded and collapsed. By clicking the presentation icon, the associated chart of the item is shown. The key icons indicate the existence of repeat keys while the warn signs indicate invalid values.
Fig 5.
Completeness page of the web-application.
Calculated completeness of the study data, i.e., if all items have been completed for each subject. The hierarchical structure of the metadata is displayed similar to the analysis page. Colored bars indicate the completeness of each metadata element.
Fig 6.
PDF page of the web-application.
This page consists of a PDF viewer to view the generated PDF in the browser. It contains all calculated statistics and can be downloaded for later usage.
Fig 7.
Invalid value page of the web-application.
This page shows all detected invalid clinical data entries in the ODM file. For each error the entire path of the invalid entry in the hierarchical clinical data structure and the reason why it was considered invalid is displayed. The list can be filtered for each characteristic and exported as CSV file.
Table 3.
Table of performance benchmarks.