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The current workflow of generating analysis results involves the end user generating the Analysis Data Model (ADaM) dataset, followed by generating the display in a static format such as RTF or PDF using the ADaM dataset. The Analysis Results Metadata (ARM) for define.xml is retrospectively generated, which provides 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 and analysis results data which leaves a gap in standardization.The The current process is expensive, time-consuming, and lacks automation and traceability, leading to unnecessary variation in analysis results reporting.
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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/SAP and to input ADaM data
- Open-source tools for designing, specifying, building, and generating analysis results data
To achieve these goals, the ARS team has been working toward developing 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 (ARM-TS) and an Analysis Results Data (ARD) 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.
To address the current limitations of analysis results and associated metadata reporting, we are proposing a new workflow that shifts the focus from retrospective reporting to prospective planning. Specifically, we propose that end-users generate the Analysis Results Metadata Technical Specification (ARM-TS) a technical specification to l prior to generating a display, rather than after the display has been created. This approach will allow for better planning and standardization of the analysis process, resulting in more consistent and traceable reporting.
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