c Chao
on

 

Hi,

I am using the Pinnacle 21 v2.1 to validate the define 2.0 XML and met a ERROR DD0001 as below,

      Element 'MetaDataVersion' cannot have character [children], because the type's content type is element-only.

[SDTM Part]

  <MetaDataVersion OID="MDV.CDISC01.SDTMIG.3.1.3.SDTM.1.3"
      Name="Study XXX, Data Definitions"
      Description="Study XXX, Data Definitions"
      def:DefineVersion="2.0.0"
      def:StandardName="SDTM-IG"
      def:StandardVersion="3.1.3">

[ADaM Part] 

  <MetaDataVersion OID="MDV.CDISC01.ADaMIG.1.0.ADaM.2.1"
      Name="Study XXX, Data Definitions"
      Description="Study XXX, Data Definitions"
      def:DefineVersion="2.0.0"
      def:StandardName="ADaM-IG"
      def:StandardVersion="1.0">

Could you help to review and give me some advice?

 

Thanks,

Chao

Forums: Define.xml

j Jozef
on June 2, 2016

Are you having 2 "MetaDataVersion" elements within the same file (one for SDTM and one for ADaM)? Although this is explicitely allowed by the XML-Schema, it is not what the FDA and other authorities want - they want separate define.xml files for SDTM and for ADaM.
The error code however points to another problem. It looks as you have somewhere beteen <MetaDataVersion OID="..."> and </MetaDataVersion> one or more characters that is not within an element, but between them. This is an XML-Schema error. I see this happening from time to time when people generate their define.xml starting from a Word document or from an Excel.
The best way to find out what the the reason of the error is (and at what position exactly), is to open the define.xml in an XML-editor, and to validate it against the XML-Schema. There is a white paper on the CDISC define.xml website (still for define.xml 1.0, but it is very similar for define.xml 2.0) explaining this.
Also not a bad idea to learn the basics of XML (takes you 2-3 hours...) and about XML validation against the XML-Schema.

c Chao
on June 7, 2016

@XML4Pharma, Thanks for your comments. This issue was fixed by removing a unexpected single quotation mark.

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