Define.xml

Hi,

When codelists are provided both on the value and variable levels, this check seems to be triggered. According to define.xml specification, it is possible to have them on both levels:

Note that there is no requirement to provide a codelist on a parent variable if codelists are provided at the Value level, though one can be provided if desired. If the user provides codelists at both levels, it is expected that a codelist defined at the Variable level will be a superset of all codelists specified at the Value level for the specified Variable.

Pinnacle21 Community v2.1 picks up the follwing error when I validate my define.xml v2.0, but I think this is a false-positive.

IT.IE.IETESTCD,Inclusion/Exclusion Criterion Short Name,Incl/Excl Criterion Short Name

I got the DD0039 error when validating my define.xml 2.0 and noticed that the SDTM 3.2 config file has a different order from the SDTMIG 3.2 for EGLEAD and EGMETHOD.

EGLEAD is listed before EGMETHOD in the SDTMIG 3.2 while EGMETHOD comes earlier in the config file.

I am wondering if this is fixed in the next version.

Thank you.

-Ebi

Hi,

In v2.1 when a dataset is located in a subfolder, this check is triggered as the subfolder name seems to be used to compare values.

    <def:leaf ID="LF.TA" xlink:href="datasets/ta.xpt">
     <def:title>ta.xpt</def:title>
    </def:leaf>

    SASDatasetName="TA"

Hi,

I'm getting DD0074 (Variable/Value Level Origin Type mismatch).  For LBTESTCD at the Variable level the Origin is 'eDT, CRF' because some lab tests come from eDT, some come from CRF, and some could be both. At the Value level the Origin for the specific test is specified as either 'eDT', 'CRF', or 'eDT, CRF'.  Please check.

Thanks! 

Hi,

I'm getting DD0055 for Class=FINDINGS ABOUT for dataset FA.  I think this is a valid class as it is specified in the SDTMIG Section 2.5. Can you please check?

Thanks!

Hi,

Thanks for the new Pinnacle 21 2.1 version. It has a lot of good Define-XML v2 checks!
In the CHANGELOG you write:

Fixed CDISC stylesheet in case Where Clause range check links to variables in different domain (bug fix)

Please be aware that CDISC has published a MUCH improved stylesheet (2015-01-16) that can be used with Define-XML v2 (with or without Analysis Results Metadata).

This improved stylesheet can be found at the CDISC stylesheet library (http://wiki.cdisc.org/display/PUB/Stylesheet+Library).

Hi,

Thanks for the new Pinnacle 21 2.1 version. It has a lot of good Define-XML v2 checks!

I have a question about the following validation result coming from validating the SDTM define.xml example  that came with the CDISC Define-XML v2 package: OD0012 - Invalid root element - Define.xml must contain a root element called ODM.

Can you confirm that this is a bug?

Thanks,
Lex Jansen

Dear Pinnacle team, great thanks for the release of the Pinnalce 21 2.1.  It looks like there are many important and good check in the new version. Could you please help to find a reference document/page for rule DD0086 from FDA? After googling for a while I could not find any reference.