DD0063: Missing Alias

Split datasets should have special Alias element

Hi Heidi, 

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.

  <!-- Dataset Definition (QSCG) -->
      <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">
        <Description>
          <TranslatedText xml:lang="en">Questionnaire-QSCG</TranslatedText>
        </Description>
        <ItemRef ItemOID="IT.STUDYID" OrderNumber="1" Mandatory="Yes" KeySequence="1"/>
        <ItemRef ItemOID="IT.QS.DOMAIN" OrderNumber="2" Mandatory="Yes"/>
        <ItemRef ItemOID="IT.USUBJID" OrderNumber="3" Mandatory="Yes" KeySequence="2" MethodOID="MT.USUBJID"/>
        <ItemRef ItemOID="IT.QS.QSSEQ" OrderNumber="4" Mandatory="Yes" MethodOID="MT.SEQ"/>
        <ItemRef ItemOID="IT.QS.QSTESTCD" OrderNumber="5" Mandatory="Yes" KeySequence="4"/>
        <ItemRef ItemOID="IT.QS.QSTEST" OrderNumber="6" Mandatory="Yes"/>
        <ItemRef ItemOID="IT.QS.QSCAT" OrderNumber="7" Mandatory="Yes" KeySequence="3"/>
        <ItemRef ItemOID="IT.QS.QSORRES" OrderNumber="9" Mandatory="No"/>
        <ItemRef ItemOID="IT.QS.QSSTRESC" OrderNumber="10" Mandatory="No" MethodOID="MT.QSSTRESC"/>
        <ItemRef ItemOID="IT.QS.QSSTRESN" OrderNumber="11" Mandatory="No" MethodOID="MT.QSSTRESN"/>
        <ItemRef ItemOID="IT.QS.VISITNUM" OrderNumber="13" Mandatory="No" KeySequence="6"/>
        <ItemRef ItemOID="IT.QS.VISIT" OrderNumber="14" Mandatory="No"/>
        <ItemRef ItemOID="IT.QS.VISITDY" OrderNumber="15" Mandatory="No"/>
        <ItemRef ItemOID="IT.QS.QSDTC" OrderNumber="16" Mandatory="No" KeySequence="5"/>
        <ItemRef ItemOID="IT.QS.QSDY" OrderNumber="17" Mandatory="No" MethodOID="MT.QSDY"/>
        <Alias Context="DomainDescription" Name="Questionnaires"/>
        <def:leaf ID="LF.QSCG" xlink:href="qscg.xpt">
          <def:title>qscg.xpt</def:title>
        </def:leaf>
      </ItemGroupDef>

Define-XML v2.0 specs. #5.3…

Define-XML v2.0 specs. #5.3.10.2 (page 73):

"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"

Where can an alias be defined?

Hi Sergiy,

Thanks for the prompt reply!

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?

Thanks, Heidi