s Sophia
on

 

Hi, 

What would be the appropriate place to enter ADaM dataset-level comments, such as what should be included in an ADaM (as shown in the "Database Comment" column in the included screenshot) in the Excel ADaM spec and define.xml? Should they simply be included in dataset descriptions ADRG instead?

Thanks, 

Sophia 

pic

Forums: Define.xml

j Jozef
on May 23, 2019

In the define.xml, this goes into a def:CommentDef, which is referenced from the ItemGroupDef through the def:CommentOID attribute.
For example:
<ItemGroupDef OID="IG.ADAE" Name="ADAE" ... def:CommentOID="COM.ADAE" ...>
... </ItemGroupDef>

and further on:
<def:CommentDef OID="COM.ADAE">
<Description><TranslatedText xml:lang="en">All records in the SDTM AE domain are included in the ADAE datasete"></TranslatedText></Description>
</def:CommentDef>

Comments should NOT go into "Description" under "ItemGroupDef".

All this is clearly defined in the define.xml 2.0 specification, which you should read before trying anything out.

How you do this in the Excel spec that you use, I don't know, I use software that provides wizards for this.

With best regards,
Jozef Aerts, CDISC Define-XML development team

P.S. How can you have a "Comment" column and a "Dataset Comment" column in your picture? What kind of thing is this?

s Sophia
on May 23, 2019

Hi Jozef, 

Thanks for your reply. It is very useful information. However, we use EXCEL to create the specification and convert it to define.xml in our company. 

To answer your question about "Dataset Comment". This column is the comment at the datasets level and don't know how to map it into the define.xml yet. The comment  column in datasets sheet goes into to the document in define.xml as you can see below. 

 

Thanks, 

Sophia

pic

j Jozef
on May 23, 2019

Yes, when using black-box software and only looking at the result VIEW in the browser that is a result of the stylesheet, than it's hard isn't it?
Best is to have a look at the SOURCE XML of the define.xml, opening it e.g. with NotePad++. You will then easily find out where the content of the tab "Dataset Comment" goes into. If in your case you do not find the text "All records in SDTM AE domain ,,," in the source XML, then it means that that tab is not treated by your software. If you do find it in the SOURCE XML, but not in the VIEW in the browser, then it means that the text is not picked up by the stylesheet - you than have a stylesheet issue.

I would also strongly encourage you to take a CDISC Define-XML course. These are organized regularly in as well North America as in the USA and a few times a year in Asia. After this one-day course, you will be an expert in define.xml, and know what you are doing ... ;-)

With best regards,
Jozef Aerts, CDISC Define-XML development team (and Define-XML trainer at CDISC)

 

j Jozef
on May 23, 2019

I will have a try myself this weekend ...

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