Define.xml

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

Hi,

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, 

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

getting above error. any suggestion.

Thanks & Regards,

Deepali

 

 

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">

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?

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

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!

Hi, I think check OD0019 should be updated to allow SAS format name longer than 8 characters. I got an error in a CodeList Element saying that my SASFormatName attribute was not valid even though it was less than 32 characters and respected the SAS format naming convention. Moreover, nothing in the Define.xml 2.0 specifications states that a SAS format name should be <=8 characters (see page 82 of Define.xml 2.0 specifications). I think this check should be updated accordingly. Thanks Pierre

When the prefix-namespace declaration for the namespace "http://www.cdisc.org/ns/def/v2.0" is not on the top "ODM" element (where it is not necessary at all), but e.g. on the "MetadataVersion" (where it is needed because of def:DefineVersion), I still get an error DD0002 - Missing or invalid 'def' namespace reference. This error should not be thrown, as it is allowed to define namespaces everywhere in an XML document. It is not necessary at all to define them at the top element when not immediately necessary.