Non-standard variables (NSVs)
This supplement follows the practices outlined in the "Alternative Representation of Non-Standard Variables" proposal (available in draft form at http://wiki.cdisc.org/x/Ui68AQ). Accordingly, SDTM-based examples containing sample data requiring the use of a variable outside the standard set of variables included in the SDTM are represented not with Supplemental Qualifier records, but with NSVs appended to the end of the parent domain, followed by sample value-level metadata for the NSVs. CDASH-based examples containing fields that collect data requiring the use of NSVs annotate their SDTMIG target as variables in the domain’s corresponding NS-- dataset, rather than as QNAM/QVAL pairs in the domain’s corresponding SUPP-- dataset (e.g., for the NSV "XXCCCC", as "NSXX.XXCCCC" rather than as "SUPPXX.QVAL where SUPPXX.QNAM = 'XXCCCC'"). In order to avoid confusion between standard variables and NSVs in the sample datasets, NSVs have been rendered visually distinct, as shown below, with white text on black in the header row, and separated from the standard variables by a small space. Note that NSVs should still be represented using SUPP-- when building SDTM datasets.
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 C, Non-standard Variables (NSVs).
Device Properties (DO) Domain
This supplement is based on SDTMIG-MD v1.1, which includes the DO domain. There are ongoing discussions to deprecate the DO domain in the next version of the SDTMIG-MD; however, this had not been finalized at the time of publication of this supplement.