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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. The Analysis Results Metadata (ARM) for define.xml Define-XML is created retrospectively as high-level metadata documentation about analysis displays and results (Figure 1); 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, and lacks automation and traceability, leading to unnecessary variation in analysis results reporting.
Figure 1: Current State of Display and ARM Generation (insert higher resolution picture)
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- A logical model for describing analysis and results data
- Automated generation of machine-readable results data
- Improved navigation and reusability of analysis and results data
- Support for the storage, access, processing, and reproducibility of results data
- Traceability to the study protocol/statistical analysis plan (SAP) and to input ADaM data
- Open-source tools for designing, specifying, building, and generating analysis results data
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