s Suzy
on

 

OK, I'm starting this by stating that I have ZERO experience with Define.xml (in OpenCDISC or any other format), other than having a general idea as to what the output file should look like.

I just now downloaded OpenCDISC version 1.5, which has ADaM Define.xml capabilities.  I ran Define.xml as-is on my ADaM .xpt files that I had just validated.  It finished in a second, and the popup screen says "Note that you'll need to fill in some study and organization-specific values..."

I did notice that some Types and Roles did not come through, and no Controlled Terms and Formats.  In my complete ignorance of Define.xml, I throw myself at your mercy: 

How/where do I add these?

There are empty sections at the bottom of the report, Value Level Metadata, Computational Algorithms, and Code Lists; what do I need to do to populate these?  I see there is an option for Code Lists, but exactly what do I pull in here--spreadsheet, ,xpt file, ???  What do they need to contain?

 

Many, many thanks!

Suzy

 

Forums: Define.xml

s Suzy
on April 9, 2014

I did find the codelist-template spreadsheet, and added some codes to it in the format given.  I chose it in the "Code List" option and reran, but they still don't populate in the Define.xml.  Does my spreadsheet have to have a certain name?

 

Suzy

k Kunihito
on April 16, 2014

Dear Suzy,

I am not a opencdisc developer, but since this place is a community forum I would like to comment from a general define.xml perspective.

It is not easy to tell what contents should be added to the define.xml generated by the opencdisc. You would get most of the answer from define.xml specification document and Metadata Submission Guidelines(SDTM-MSG), both of which can be downloaded from the cdisc web site. I am not really sure what your current define.xml looks like, but as a general advise you would probably need to make sure the followings:

 - Populate any missing required attributes and texts (shown in "" or a blank element like <StudyName> </StudyName>)

 - Add CodeList elements not only for the NCI codelists but also for your own codelists and external dictionaries

 - Add ValueListDef/ItemDef elements for --ORRES variables in findings domains and QVAL in SUPP-- domains

 - Add ComputationMethod elements for derived variables/values

Making these changes precisely would require substantial knowledge about the define.xml specification and SDTM-MSG.

I wish you good luck.

-Ebi

l Lex
on April 16, 2014

Please keep in mind that a define.xml file is just a format - or a vehicle - to transport metadata about your clinical data. You should not have to manually update a define.xml file, but you should have a process in place to publish your metadata to a define.xml file. 
From my view, manually updating a define.xml file is asking for trouble.

Best, Lex 

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