Large trials and studies generate many analysis results in the form of tables, figures and written reports. Historically, a typical workflow for producing analysis results involves the end user generating the display in a static format such as RTF or PDF from the Analysis Data Model (ADaM) dataset (Figure 1). The Analysis Results Metadata (ARM) for Define-XML (add reference) is then created retrospectively to provide high-level documentation about metadata relating to the analysis displays and results. However, there is no formal model or structures to describe analysis results and associated metadata, leaving a gap in standardization. The current process is expensive, time-consuming, lacks automation and traceability, leading to unnecessary variation in analysis results reporting.
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The Analysis Results Standard (ARS) Model has several possible implementations including leveraging analysis results metadata to aid in automation as well as representing analysis results as data in a dataset structure. The creation of an ARS technical specification could be used support automation, traceability, and the creation of data displays. An analysis results dataset could support reuse and reproducibility of results data. The following is an example of how the ARS Model could be used in a modernized workflow that shifts the focus from retrospective reporting to prospective planning (Figure 2).
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