Forums: Define.xml
Small bug which we just fixed and will be released in next version.
here's what happened:
Just a remark about "Predecessor". Although the use case for Origin Type="Predecessor" originally came from ADaM, if there is a valid use case for SDTM, this Type is not forbidden in SDTM by the specification.
Lex
I just amended my statement above. We are not going to prevent predecessor origin from SDTM
When I create a define.xml in Pinnacle 4.0.1, the Purpose column in the Datasets section is blank when select V2.0 of Define XML. When I use the same Excel template to generate the define.xml file with V2.1 of Define XML, the Purpose column some are showing Tabulation, while others no. And when it comes to the Chinese Version, it becomes another siutation.
Let's just see pictures bellow:
Interesting ... but there is no "column" "Purpose" in define.xml nor is there a "Datasets" section.
These only appear in the VIEW on the define.xml as provided by a stylesheet.
As the name says, the define.xml is an XML file, and XML has no "columns".
In Define-xml "Purpose" is an attribute on ItemGroupDef, which indeeds provides the metadata for an SDTM or SEND (Purpose="Tabulation"), or ADaM (Purpose="Analysis") each dataset.
You can always use a simple editor that supports XML, like NotePad++, to check whether there is a "Purpose" attribute on ItemGroupDef, and whether it is empty or not.
If it is always present and correctly populated, you may have a problem with your stylesheet.
Want to know and understand more? Take a Define-XML training from CDISC.
When I open the XML file, I don't see any value in the Purpose attribute of an ItemGroupDef element. Additionally, there isn't an Alias element, which is required for supplemental qualifiers. This problem occurs even if I just create an Excel file based on XPTs and generate a Define XML from it without any intermediate changes. Could someone please explain what I'm doing wrong? Screenshots in attachment.
Also, shouldn't 'SDTMIG' be used instead of 'SDTM-IG' in the Name attribute of def:Standard element? In the 'Standard Name' codelist in Define XML Controlled Terminology it is listed without a hyphen.
Pinnacle 21 Community Version 4.0.1
SDTM IG 3.3
Define XML 2.1
File Upload
Looks like a number of bugs here...
It must indeed be "SDTMIG" and not "SDTM-IG" for the "Name" attribute on def:Standard in your example.
The "Purpose" attribute on "ItemGroupDef" is "mandatory", i.e. it must always be present AND populated, with either "Tabulation" (in the case of SDTM or SEND), or "Analysis" (in the case of ADaM).
You can always mail me (my mail address is easy to find out) for more details.
Jozef Aerts
CDISC Define-XML development team and CDISC Define-XML Instructor.
When I create a define.xml in Pinnacle 2.1.1, the Purpose column in the Datasets section is blank. When I use the same Excel template to generate the define.xml file with an older version of Pinnacle, the Purpose column has the correct value as supplied in the spreadsheet (Tabulation).
It appears that version 2.1.1. of your software might be skipping the Purpose= element in the ItemDefGroup tag.