Define.xml

Description

Questions about creating and validating Define.xml

November 26, 2015

Hi,
When I only validated the define.xml, the CDSIC SDTM Terminology can’t be selected and it seems version 2014-09-26 is default.
I tried to change “SDTM Terminology.odm.xml”under /components/config/data, but the ERROR check of “DD0027” is presented and I don’t know why.
Can I validate define.xml based on any version of SDTM Terminology? If yes, how can I make it?
Many thanks for your help in advance.

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November 10, 2015

We have been doing XML schema validation on our define.xml files using Java and ran into an issue when moving to Java 1.7.  Because we are now also using OpenCDISC to validate our define.xml files the question arose as to whether there is any value in our doing XML schema validation (as it appears that OpenCDISC is also identifying the same issues as our XML schema validation).  By performing XML schema validation, are we supplementing or simply duplicating OpenCDISC functionality?

Thanks

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November 4, 2015

Hi,

This is the first time I am doing Excel Define Spec for SDTM, using OpenCDISC Community 2.0.2. Though a good number of fields are populated when the Excel file is created, I still need to go in and populate missing tabs and missing fields. Is there a sample excel spec from CDISC so that I can use to populate the missing fields in a Standardized way? Thanks

 

Regards,

Hari

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October 30, 2015

Hi,

There is a column under Method called Pages. What is the column being used for? I currently have ComplexAlgorithms under Document then the Pages column has the page number listed, but once the Define xml is generated there is no link for this Pages. 

 

Please advise. 

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September 27, 2015

Hi,

I'm validating an ADaM define 2 XML file, using OpenCDISC 2.0.2. I get message D0027 (C-Code not found in CDISC Controlled Terminology) for one codelist, the one from the ADaM CT:

//CodeList[@OID='cl.PARAMTYP']/Alias[1] @Name C81225

The concept id for PARAMTYP being C81225, I guess I get this message because define.xml validation uses a fixed SDTM-only terminology?

Regards,
-- Thierry

 

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September 24, 2015

Hi,

Is CDISC Analysis Results Metadata v1.0 for Define-XML v2 currently implemented in Opecdisc community 2.02 version?

 

Please do let me know your thoughts.

 

Thank you.

Aadesh

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September 23, 2015

Hi, I have this message below, I dont know why, since i confirmed that C66769 goes with AESEV. 

//CodeList[@OID='CL.AESEV']/Alias[1] @Name C66769

my define portion is below.

 </CodeList>

         <CodeList OID="CL.AESEV" Name="Severity/Intensity Scale for Adverse Events"

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September 23, 2015

Hi, 

I Created define.xml using the community version 2.02, however when i run it through validation it give me the warning messages below, This doesnt happen when i use OpenCDISC validator 1.5. 

Any help will be much appreciated.

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September 16, 2015

Hi, 

I have this message below, I dont know why, since i confirmed that C66769 goes with AESEV. 

 

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September 16, 2015

Hi, 

I am using OpenCDISC 2.02 to generate define.xml version 2.0, however i need help if there is a document that show, how to fill in details in the Excel Spec?


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