The ARS Model is currently not considered to be a replacement for the Analysis Results Metadata ( ARM ) for Define-XML standard (https://www.cdisc.org/standards/foundational/define-xml/
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. The ARM for Define-XML meets a regulatory need and has not been modified. However, components have been added to the ARS
model Model to facilitate the creation of ARM for Define-XML, including the reason and purpose of each analysis and
the ability to create documentation references for both analyses and outputs.
The ARM for Define-XML was developed for
the purpose the purpose of submitting to regulatory agencies
to provide to provide traceability for a given analysis result to the specific ADaM data
that were used as used as input to generating the analysis result.
The ARM for Define-XML is often created retrospectively and only for key analyses. In contrast, the ARS Model is intended to leverage analysis results prospectively to enable automation, reusability, and traceability.
The creation and use of the ARS model Model is based on the assumption that the input analysis datasets will be "analysis-ready," , as defined in ADaM v2.1 Section 3.1, "Fundamental Principles" of the Analysis Data Model v2.1 document (add referenceFundamental Principles (https://www.cdisc.org/standards/foundational/adam/adam-v2-1). This means that the ARS metadata components are designed only to define and describe the minimal additional processing needed to produce results from analysis-ready analysis datasets; they are not intended to describe more complex data manipulations such as transformations or transpositions(e.g., transformations, transpositions).