h Harald
on

 

I am just curious about the following finding:

I am using Define Standard 2.1 and correctly populated Excel Specs to generate the Define.

When applying a Comment on Valuelevel, then the corresponding Wording is displayed twice (see attached screenshot).

Interestingly, when having a derivation Method assigned on Valuelevel, this does not happen and the description of the Method is only shown once.

Within the code, the declarations seems reasonable:

<def:CommentDef OID="COM.COMM.AE.EXCLUDED">
            <Description>
               <TranslatedText>Records originating from eCRF form 'Adverse Event' are not transferred into AE domain in case eCRF question 'AE Type' is answered 'Solicited' and AESER = N.</TranslatedText>
            </Description>
         </def:CommentDef>

And same for the Item Def where it is referred:

<ItemDef OID="IT.AE.AESER.AE.AESPID.NE." Name="AESER.AE.AESPID.NE." DataType="text"
                  Length="1"
                  SASFieldName="AESER"
                  def:CommentOID="COM.COMM.AE.EXCLUDED">
            <def:Origin Type="Assigned" Source="Sponsor"/>
         </ItemDef>

Only thing I can think of is that the CommendOID is also referred at WhereClause:

         <def:WhereClauseDef OID="WC.AE.AESPID.NE." def:CommentOID="COM.COMM.AE.EXCLUDED">
            <RangeCheck SoftHard="Soft" def:ItemOID="IT.AE.AESPID" Comparator="NE">
               <CheckValue/>
            </RangeCheck>
         </def:WhereClauseDef>

If this is the reason for the duplication, is it indented by P21 team to fix that issue in Define.XML Generator?

If this is not the reason, what might be the cause?

Attached Files

Forums: Define.xml

j Jozef
on January 30, 2025

Can you check a few things in the snippet in the source XML of the generated define.xml (you can e.g. use NotePad++ for that)?
Is it that there are two "def:CommentDef" with the same OID? Your snippet suggests that.
Is it that there are two "TranslatedText" elements within the same def:CommentDef/TranslatedText? Your snippet doesn't have that.
Another reason may be that you have an error in your stylesheet, in case you use a bad one or made changes in a good one.

These are the things we learn to debug for in the CDISC Define-XML trainings. Very often, after taken this course, you can usually correct such issues within 2 minutes.

You may also think about a WYSIWYG (What-you-see-is-what-you-get) software for generating your define.xml-s.

Lex
on January 30, 2025

In Value Level Metadata the Define-XML v2.x specification allows for 2 types of comments:

  1. A comment related to the WhereClause definition (WhereClauseDef)
  2. A comment related to the Item (virtual variable) defined by the WhereClause (ItemDef)

My guess is that the metadata specification that P21 uses does not distinguish between the 2, so it is unclear whether the comment should be attached to the ItemDef or the WhereClauseDef. The application apparently decided to attach the comment to both in this case.

You could say that the stylesheet should not display the same comment twice, but there is a realistic assumption that you would not attached the exact same comment to an Item definition and a WhereClause definition.

 

h Harald
on February 3, 2025

Dear Jozef and Lex, thanks for your replies.

Is it that there are two "def:CommentDef" with the same OID? Your snippet suggests that.

--> No, the CommentDef's are unique.

Is it that there are two "TranslatedText" elements within the same def:CommentDef/TranslatedText? Your snippet doesn't have that.

--> No, that's not the case.

My guess is that the metadata specification that P21 uses does not distinguish between the 2, so it is unclear whether the comment should be attached to the ItemDef or the WhereClauseDef. The application apparently decided to attach the comment to both in this case.

I agree. In the past, the P21 Define specs held an own Sheet for the WhereClauses, whereas now that Sheet vanished and the WC-Definition is now integrated on the ValueLevel sheet. Might be a reason.

However, I just tried out to remove the def:CommentOID from the WC declaration code and the duplicate was gone, as expected.

@P21 development: Is that issue known and intended to be fixed? From my point of view, it might be sufficient to leave the def:CommentOID with the ItemDef declaration, as its OID combines the item and the applicable WhereClause and is thereby unique (e.g. "<ItemDef OID="IT.AE.AESER.AE.AESPID.NE."), so no futher need to also include it with the WhereClauseDef.

 

 

j Jozef
on February 4, 2025

WYSIWYG ...
You mean something like this?
WhereClause comment versus ValueList comment - WYSIWYG tool

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