Split datasets should have a special Alias element.
A Define-XML v2.0 standard package from CDISC includes an example for SDTM data. Here is a definition for one split domain (lines #1757 - 1791). Note, that Alias attributes have the same values/descriptions for all 3 split QS domains in CDISC example.
<ItemGroupDef OID=“IG.QSCG” Domain=“QS” Name=“QSCG” Repeating=“Yes” IsReferenceData=“No” SASDatasetName=“QSCG” Purpose=“Tabulation” def:Structure=“One record per questionnaire per question per visit per subject” def:Class=“FINDINGS” def:CommentOID=“COM.DOMAIN.QS” def:ArchiveLocationID=“LF.QSCG”>
“The Alias element provides a reference to the Domain description in the case where an ItemGroupDef represents a split domain or a reference to a C-Code when a CodeList, CodeListItem or EnumeratedItem corresponds to a CDISC Controlled Terminology.”
“Usage: When used for regulatory submission, the Alias element is required for each ItemGroup that is part of a Domain that has been split into different datasets”
Can you tell me whether this can be resolved using the xls specifications used to create the define? Thus, can an alias be specified anywhere in the excel sheet?
Validating a define.xml containing two findings about datasets, FADS and FAMH, we get the error ‘DD0063 Missing Alias’ for both. The dataset labels are for FADS: Findings About Disposition and for FAMH: Findings About Medical History. The define.xml is created and validated using Pinnacle 21 Community.
What does this error mean and how can it be resolved?