Define.xml

Description

Questions about creating and validating Define.xml

December 23, 2014

I've tried a few times to generate Define.xml for sdtm, specifiying SDTM 3.2 in the drop down list.  Still, the version that shows up in the define specs says 3.1.3.

I've validated the define files, and no errors, but I did have to change this 3.1.3 to 3.2 manually, in the first tab of the files.  Would like to know if there's any other place this could be an issue?

 

Thanks much, a very nice product.

 

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December 23, 2014

Hello,

  First,  in advance, apologies if this is covered under another thread; I've looked and don't see it.

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December 19, 2014

Hi,

I'm not able to correctly generate the value level metadata for the define.xml of the SDTM domains.

Moreover the CRF page numbers of the "Origin" column are not displayed.

Attached you can find the excel specification

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December 12, 2014

Hi Team,

Firstly I would like to thank you guys for the information provided about FDA rules and define2.0 in webinars over the last couple weeks. I was very excited to try the new tool, however, when I tried to use the tool for the new features like creating define from the excel spec and creating excel specs from existing define1.0 a dialog box popped up with serious error. so my questions are

1) do we need to fill in the excel specs completely all the information like study name, protocol name etc to create a define, 

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December 1, 2014

//CodeList[@OID='MDV.xxxx']/CodeListItem[1]/Decode[1]/TranslatedText[1]

getting above error. any suggestion.

Thanks & Regards,

Deepali

 

 

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November 12, 2014

The OpenCDISC Validator is reporting an error DD0024 for the variable CM.CMST/ENRF.  I'm running  a "define only" check job.  These variables use a code list called STENRF.  However when I look at the contents of the define.xml for the STENRF code list it appears correct to me (see below).  Is the DD0024 rule mis-firing?

        <CodeList OID="STENRF" Name="STENRF" DataType="text">

            <CodeListItem CodedValue="AFTER">

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October 15, 2014
I'm using v1.5 to check my v1.0 define.xml file with the config-define-1.0.xml. In the output report, I only see the one message OD0080 which indicated "itemDef/Codelist 'DataType' mismatch" for the variables: AELLTCD, AEPTCD, AEHLTCD, AEHLGTCD, AEBDSYSCD, and AESOCCD. However, when I looked at the data, everything is OK. Could this be a false-positive test result that I can ignore?
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September 26, 2014

Hello everyone,

I recently started to use opencdisc to create define.xml but wasnt able to figure out how to link the annotated CRF to define.xml, can someone please help me understand how to link the CRF so that I can get the hyperlinks in origin column.

 

Thanks

Ram

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September 11, 2014

Hi,

I'm attempting to answer two questions with one post!  Could you please confirm the Define.xml version produced by Validator 1.5?  I'm assuming it's Define.xml version 1.0 using style sheet define2_0_0.xsl, but I'm honestly unsure how to verify this.  

I reviewed the slides from the webinar last month... when will the Community Validator 2.0 be released?  Thanks!

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