ASSIGNING NATURAL KEY variables from SUPPQUAL

Pinnacle 21 Support Define.xml
1

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).

2

A PhUSE working group is currently developing a new stylsheet. We have implemented the display of natural keys from SuppQual.

Of course, the stylesheet is just for display. Whether software that imports a Define-XML file uses these keys is a different story.

3

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”/>

</def:ValueListDef>


Machine Make

<def:Origin Type=“CRF”>
<def:DocumentRef leafID=“LF.blankcrf”>
<def:PDFPageRef PageRefs=“11” Type=“PhysicalRef”/>
</def:DocumentRef>
</def:Origin>

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

4

Does the current P21 engine 2508.0 allow the use of QNAM.xxxxx as key variable in the define without causing additional issue while trying to resolve the duplicate records issue?

Thanks,

ChuanFeng Shih

5

No, this functionality is not available.

  • There is low business need. Almost nobody asks for it.
  • New upcoming SDTMIG 4.0 will not have this issue.