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Metadata for NSVs, from the define.xml file that would accompany the submission, are tabulated below the example; only those attributes or elements that assist the example are included. (For more information on variable-level metadata in general, see Define-XML v2.1, Sections 4.3 and 5.3.2, available at https://www.cdisc.org/standards/data-exchange/define-xml). A list of all NSVs used in this document, and the variable-level metadata that might become normative for the NSVs should they be promoted to standard variables, is included in Appendix BC, Non-standard Variables (NSVs).

Device Properties (DO) Domain

This supplement is based on the SDTMIG-Medical Devices MD v1.1, which includes the DO domain. There are ongoing discussions to deprecate the DO domain in the next version of the SDTMIG-Medical DevicesMD; however, this has had not been finalized at the time of publication of this supplement.

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