The ARS Model is currently not considered to be a replacement for the ARM for Define-XML standard (available at https://www.cdisc.org/standards/foundational/define-xml/). The ARM for Define-XML meets a regulatory need and has not been modified. However, components have been added to the ARS Model to facilitate the creation of ARM for Define-XML, including the reason and purpose of each analysis and documentation references for both analyses and outputs. The ARM for Define-XML was developed for the purpose of submitting to regulatory agencies to provide traceability for a given analysis result to the specific ADaM data 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 is based on the assumption that input analysis datasets will be "analysis-ready," as defined in ADaM v2.1 Section 3.1, Fundamental Principles (https://www.cdisc.org/standards/foundational/adam/). This means that 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 (e.g., transformations, transpositions).