General questions about creating a define.xml

  Hi Debora,  I think that

 

Hi Debora, 

I think that the define.xml tool is quite outdated now. The new more robust, user friendly and free application will be released soon.

The current tool uses input data and SDTM metadata to create a template as a star point for further direct editing of those XML document. It was considered enough for people with CDISC and XML expertise. Therefore:

1. Value Level Metadata is not a part of your XPT files metadata. It's expected to be entered manually.

2. You need to convert information from your Excel table into define.xml format. Example:

...

<def:ComputationMethod OID="SEQNO">Use SQL rownum function</def:ComputationMethod> 

....

<ItemDef OID="AESEQ"   Name="AESEQ"  

  DataType="integer" Length="5"  Origin="Derived" def:Label="Used to Sequence AEs within subjects" 

  def:ComputationMethodOID="SEQNO"> 

</ItemDef> 

...

See CDISC  crt_ddspecification (define.xml) document for details. 

3. Now the tool use SDTM specifications, rather than your files metadata. In addition to such prescriptive approach the new version will have an option to use actual data labels and other meatadata. 

4. Did you ensure that in your codelist excel file you populated both CodeList Definition and CodeList Assignments tables/spreadsheets?

Yes, all XML files are editable.

Regards, 

Sergiy

P.S. The new version of define XML tool will be more user-friendly and flexible. It will be multi-step process:

1. Extract your files metadata into Excel like template

2. Enter or download all additional info (value level, code lists, comp. methods, study metadata, etc.)  into Excel

3. Generate XML final file

You will work with Excel tables, rather than edit XML file.

 

I am new to OpenCDISC but not to the SDTM or submissions

I have downloaded v1.4 and have worked through creating a base DEFINE.XML and have uploaded the Codelist Excel file but do not see where I can upload the Computations and variable metadata referred to in this thread.  Is this functionality not part of v1.4?  If it is how do I include that as part of the upload, my assumption is that it will be part of the same Excel workbook as the codelist.

Thank you in advance.

George

 

Hi George,  Unfortunately a

Hi George, 

Unfortunately a current version of OpenCDISC define.xml tool does not use Excel files to upload Computational Methods and other details like Source or Value List. You need to edit define.xml file manually to add new information.

Kind Regards,

Sergiy 

 

Thank you Sergiy.  So your

Thank you Sergiy.  So your reference to a new updated version:

"Hi Debora, 

I think that the define.xml tool
is quite outdated now. The new more robust, user friendly and free application
will be released soon."

Any ETA on the new release?

 

Thanks!

george

A new 1.4.1 release will be

A new 1.4.1 release will be within few weeks, but it does not have any updates for the define.xml tool

define.xml

What method do you recommend for creating a complete define.xml?

Hi Jake,  It’s difficult for

Hi Jake, 

It’s difficult for me to advise without knowing your experience with different technologies and tools.

As a member of Pinnacle 21 team I am mostly using the OpenCDISC Enterprise. Also I can work with OpenCDISC define.xml templates and complete missing parts with XML editors like  XML Spy. The same is true for other users. They prefer particular methods based on their experience and availability of tools.

Regards,

Sergiy