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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, and lacks automation and traceability, leading to unnecessary variation in analysis results reporting.
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The goal for the future state of analysis results reporting is where we can have a standard that will support the following objectives:
- Use analysis results metadata prospectively to drive the automation of results
- Support storage, access, processing and reproducibility of results
- Improved navigation and reusability of analyses and results
- Traceability to Protocol/SAP and to input ADaM data
are analysis results are machine-readable, easily navigable, and highly reusable. We envision the following:
- A logical model for describing analysis analysis results and results dataassociated metadata
- 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
•Use analysis results metadata to drive the automation of results
•Support storage, access, processing and reproducibility of results
•Improved navigation and reusability of analyses and results
•Traceability to Protocol/SAP and to input ADaM data
To achieve these goals, a logical model to fully describe analysis results metadata has been developed. This logical model will enable the implementation of an Analysis Results Metadata Technical Specification and an Analysis Results Data framework. ARM-TS can be used to support automation, traceability, and the creation of data displays while the ARD framework will support reuse and reproducibility of results data.
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