Large trials and studies generate many analysis results in the form of tables, figures and written reports. Often, analysis results are created and represented as static PDF documents that may contain hundreds of tables. These tables are difficult to navigate and there can be significant variability between sponsors. Generating these reports is expensive and are typically only used once, offering limited reusability. 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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