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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