Two example reporting events have been created to show the use of the ARS model to represent:
- Prospective analysis definition metadata,
- Analysis results with accompanying contextualizing metadata, and
- Metadata describing the layout of outputs displays.
The "Common Safety Displays" reporting event contains the specifications for 5 commonly used safety displays and the analyses required to generate the results represented in the displays, and the "FDA STF" reporting contains similar information for summary of demographics and baseline characteristics display ("Table 2").
Using example data generated for the CDISC Pilot study, analysis results for each of the 6 outputs have been generated according to the analysis specifications recorded in the example reporting events. The analysis results are also represented in the example reporting events, and each result value is associated with sufficient metadata to relate it to the metadata describing the analysis which generated the result value.
All metadata describing the outputs and analyses in each of the example reporting events, as well as all of the analysis results, are available for download in JSON format via the ARS Application Programming Interface (API) which is available at https://ars-hackathon-dev.azurewebsites.net/docs#/.
Each of the following sections contains an image of the one of the example output displays and a list of the corresponding analyses, which has been derived by programmatically extracting and reformatting the details of each of the analyses referenced in the listOfPlannedAnalyses for each of the reporting events.