The ARS Model is currently not considered to be a replacement for the ARM for Define-XML standard (which is 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.
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