Multiple Origins in SDTM

a Aadesh

on June 1, 2016

Hi,

I have a variable which is coming from CRF as well as eDT, i am using Pinnacle 21 to generate my define.xml, however i am not able to show both origins together in the define.xml output. Below is the xml code, if i add eDT, CRF in the excel as Origin, it doesn't pick up the pdf page number.

I have also attached a screenshot of my specs.

Please advice.

<ItemDef OID="IT.CF.CFORRES" Name="CFORRES" DataType="text" Length="200"
SASFieldName="CFORRES">
<Description>
<TranslatedText xml:lang="en">Result or Finding in Original Units</TranslatedText>
</Description>
<def:Origin Type="CRF">
<def:DocumentRef leafID="LF.blankcrf">
<def:PDFPageRef Type="PhysicalRef" PageRefs="59 89"/>
</def:DocumentRef>
</def:Origin>
<def:ValueListRef ValueListOID="VL.CF.CFORRES"/>
</ItemDef>

Thank you,

Aadesh Shah

Attached Files

Capture.JPG

Forums: Define.xml

j Jozef

on June 1, 2016

Multiple origins

The anwser is described at: https://www.pinnacle21.net/forum/origin-metadata-records

You should describe this at the value-level, i.e. "split" your data according to the origin in different categories.
In some cases, I would even recommend to generate different datasets (for the same domain), if the data structure is pretty dependent on the origin of the data. That would make it easier for the reviewer as well as for yourself during the mapping.
It also looks as you are trying to generate your define.xml "post-SDTM" which is never a good idea. The better way is to use a mapping tool that also generates your define.xml and keeps it "in sync" with the mapping itself.