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 output 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; the "FDA Standard Safety Tables and Figures" reporting event contains similar information for the summary of demographics and clinical characteristics display ("Table 2"), which is one of the safety tables defined in the FDA's Standard Safety Tables and Figures: Integrated Guide document. ARSP-2 - Getting issue details... STATUS
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 API (available at https://ars-hackathon-dev.azurewebsites.net/docs#/) ARSP-33 - Getting issue details... STATUS .
Each of the following sections contains an image of the 1 of the example output displays and a list of the details of the specifications for both the output and each of the analyses that have been defined to generate the results for each output display. The lists of output and analysis details have been derived by programmatically extracting and reformatting the details of each of the outputs and analyses referenced in the listOfPlannedAnalyses attribute for each of the reporting events.