Define.xml

Is define.xml Version 2 planned to be released with OpenCDISC on a specific time point?

Thanks a lot for your input and best regards,

Pablo Orosco Joerger

Hi,

Do I have to include LBORRESU = "none" into the user-defined codelist in the define.xml? Since actually there is no unit, I don't see a reason to list it.

Thanks in advance!

Hi!

In the CDISC Metadata submission package I have an define.xml example. when I open it I can see that some borders are not shown when fields are blank. This looks somehow not nice. Does anyone know why this is?

If I use the define.xsl 2-0-0 out of the package to create my define.xml.

I hope that someone can answer my question!

Best regards

Hi!

I have a questions regarding the define.xsl 2-0-0. Using this xsl does not automatically mean that I am using Define.xml V2.0, or? I can still use xsl 2-0-0 and xml V1.0? Since the Define.xml V2.0 is not yet covered by the CDISC checker, I would rather go with the Define.xml V1.0.

Thanks in Advance!

Prefacing context: I'm working off of version 1.0 of the define.xml spec.

Hi,

I am currently working with define.xsl 2-0-0 to create Define.xml V2.0. I know that it is not yet on the list of the FDA standards, so I would like to know if version 2 can be checked by the open cdisc validator?

As I already mentioned in the "rules" section (http://www.opencdisc.org/projects/validator/rules/dd0005) this rule is essentially wrong as it violates the basic XML rule that the attributes may come in any order.
There is no single reason for this rule, it does not make sense, is counterproductive and thus should be removed.

Hi !

Since I am pretty new to this define.xml / SDTM topic I do have a dozen of questions. In the define.xml I am listing the LBTESTCD (and other xxTESTCD) into the VLM section. For each LBTEST I assigned a LBTESTCD accordingly which is also listed in the CRF. The source data also contains the mostly correct LBTESTCD's (some of them I had to change though), so what exactly is my "origin" of LBTESTCD then? Assigned, eDT, CRF? Since the LBTESTCD is not directly mentioned in the original CRF, I would assume that CRF is wrong.

Thanks for your help in advance!

Hi!!

The new Trial Summary Domain has en expected variable TSVALCD. Is this supposed to be in the codelist, thus, linked to it? In the CDISC example define.xml 2.0.0 all the new variables do not show up yet.

Thanks in advance!

Hi,

I have a little problem with linking FATESTCD and FATEST in define.xml as VLM. The problem is that FATESTCD and FATEST are not a unique pair (sponsor accepted as it is...). So I have one value for FATESTCD and 5 values for FATEST. I created 5 rows for FATESTCD, but cannot assign the correct labels according to FATEST.

An example program is below (with only two rows instead of 5)