t Thierry
on

 

I found a bug when validating a define.xml following the 2.1 standard.
As far as I can understand, it had nothing to do with the 2 existing messages for DD0138
(if Google Translate can be trusted for the Japanese conversation ^_^)

My define.xml file contains:

      <def:Standards>
        <def:Standard OID="std.ig" Name="ADaMIG" Type="IG" Version="1.1" Status="FINAL"/>
        <def:Standard OID="std.ct.adam" Name="CDISC/NCI" Type="CT" PublishingSet="ADaM" Version="2024-03-29" Status="FINAL"/>
        <def:Standard OID="std.ct.sdtm" Name="CDISC/NCI" Type="CT" PublishingSet="SDTM" Version="2024-03-29" Status="FINAL"/>
        <def:Standard OID="std.ct.define" Name="CDISC/NCI" Type="CT" PublishingSet="DEFINE-XML" Version="2024-03-29" Status="FINAL"/>
      </def:Standards>

When validating with P21 Community 4.1.0 (engine PMDA 2311.0) , I get:

DEFINE DD0138: 1 Error - Referenced Standard is missing
   | Standard OID, Standard Type, Standard Name = std.ct.define, CT, DEFINE-XML | Referenced Standard is missing (Error)

I noticed in the log messages of the validator the following line:

2024-09-25 15:55:21 [ForkJoinPool.commonPool-worker-1] WARN  n.p.d.v.r.DefaultStandardLookup - No configuration was provided for the terminology: std.ct.define

In C:\Users\<name>\Documents\Pinnacle 21 Community\configs\data\CDISC\Define-XML\latest,
I found that the file Define-XML Terminology.odm.xml is the one for CT 2024-03-29.
I therefore created C:\Users\<name>\Documents\Pinnacle 21 Community\configs\data\CDISC\Define-XML\2024-03-29,
and copied there the file Define-XML Terminology.odm.xml.

I re-validated, and the message disappeared.

Is this bug also present in P21 Enterprise ?
- If yes, I have to explain it in the ADRG.
- If not, I can just use the workaround above to avoid a message that the reviewer will not have.

Thanks
-- Thierry

Forums: Define.xml

Matt
on September 25, 2024

Hi Thierry,

 

Yes, DD0138 currently doesn't accept DEFINE-XML. We have since included it in the check as the CTSTDTYP Codelist includes it. This will be corrected in a future release, and until then can be explained if you plan on including the Standard OID value in your define.

 

Kind regards,

Matt

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