ASSIGNING NATURAL KEY variables from SUPPQUAL

s Saravanan

on November 2, 2017

In SDTMIG Section 4.1.1.9 Assigning Natural Keys in the Metadata , it shows how to specify key variables when it spans across to supplemental qualifiers.

The example given was

STUDYID, USUBJID, PEDTC, PETESTCD, PELOC, PEMETHOD, QNAM.PEMAKE, QNAM.PEMODEL

Is it possible to specify such type of keys in the define.xml spec sheet and have it generated in define.xml. Is this functionality supported.

If we have to do it manually, do you think this is the right place to do it.

<def:ValueListDef OID="VL.SUPPPE.QVAL">
    <ItemRef ItemOID="IT.SUPPPE.QVAL.PEMAKE" OrderNumber="1" Mandatory="No" KeySequence="7">
        <def:WhereClauseRef WhereClauseOID="WC.SUPPPE.QNAM.PEMAKE"/>
    </ItemRef>
</def:ValueListDef>
<ItemDef OID="IT.SUPPPE.QVAL.PEMAKE" Name="PEMAKE" DataType="text" Length="1" SASFieldName="PEMAKE">
    <Description>
        <TranslatedText xml:lang="en">Machine Make</TranslatedText>
    </Description>
    <def:Origin Type="CRF">
        <def:DocumentRef leafID="LF.blankcrf">
            <def:PDFPageRef PageRefs="11" Type="PhysicalRef"/>
        </def:DocumentRef>
    </def:Origin>
</ItemDef>

Obviously, the current style sheet does not display this in TOC section and we have to modify the CDISC provided sample style sheet.

Did anyone implement this earlier.

Thanks,

Saravanan

Forums: Define.xml

j Jozef

on November 3, 2017

Assigning natural key variables for SUPPQUAL

I don't think there is a well-defined mechanism for this.
The natural keys are assigned at the ItemGroupDef/ItemRef level, and the supplemental qualifier variables do not appear there.
The reason is that SDTM and the FDA still refuse us to put such variables in the domain/dataset itself (i.e. where they belong) and just mark them as "supplemental" in the define.xml.

For the stylesheet, please remember that the stylesheet delivered by CDISC is just an example stylesheet, and that it is the sponsor's responsibility to provide an appropriate stylesheet. So you can (and should in this case) extend the stylesheet in order to make this possible. I have a lot of experience in developing stylesheets, so if you need help with this, please contact me by e-mail (address can easily be found).

l Lex

on November 3, 2017