o Oleksii
on

 

Hi,

I'm trying to update define.xml with ARM section. I use 2 datasets (ADEEG and ADSL) to populate data references. I got "Missing required def:CommentOID" message. XML syntax I wrote is below. Can anyone point me to correct place, where should I put comment attribute?

<arm:ResultDisplay OID="RD.8_2_1" Name="Table 8.2.1">
<Description>
<TranslatedText xml:lang="en"> 24 Hours EEG Evaluation. </TranslatedText>
</Description>
<def:DocumentRef leafID="LF.8.2.1">
<def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
</def:DocumentRef>
<arm:AnalysisResult
OID="AR.8_2_1.R.1"
ParameterOID="IT.ADEEG.PARAMCD"
AnalysisReason="SPECIFIED IN SAP"
AnalysisPurpose="SAFETY OUTCOME MEASURE">
<Description>
<TranslatedText xml:lang="en"> Changes in count of generalized spike-wave discharges and changes in count of 3Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase).</TranslatedText>
</Description>
<arm:AnalysisDatasets>
<arm:AnalysisDataset ItemGroupOID="IG.ADEEG">
<def:WhereClauseRef WhereClauseOID="WC.T_8_2_1.ADEEG.R1"/>
<arm:AnalysisVariable ItemOID="IT.ADEEG.AVAL"/>
<arm:AnalysisVariable ItemOID="IT.ADEEG.CHG"/>
</arm:AnalysisDataset>
<arm:AnalysisDataset ItemGroupOID="IG.ADSL">
<def:WhereClauseRef WhereClauseOID="WC.T_8_2_1.ADSL.R2"/>
</arm:AnalysisDataset>
</arm:AnalysisDatasets>
<arm:Documentation>
<Description>
<TranslatedText xml:lang="en"> The actual change in the count of generalized spikewave discharges on 24-hour ambulatory EEG from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase) were calculated and summarized descriptively. Similarly, the actual change in the count of 3Hz spike-wave discharges on 24-hour ambulatory EEG from Visit 2
(Baseline Phase) to Visit 6 (Maintenance Phase) were calculated and summarized descriptively. </TranslatedText>
</Description>
<def:DocumentRef leafID="LF.SAP_SECT_8_3">
<def:PDFPageRef PageRefs="20" Type="PhysicalRef"/>
</def:DocumentRef>
</arm:Documentation>

</arm:AnalysisResult>
</arm:ResultDisplay>

Forums: Define.xml

j Jozef
on July 19, 2019

Not a bad idea to download and read the "ARM" specification (it is at: https://www.cdisc.org/system/files/members/standard/foundational/adam/ARM-for-Define-XML.zip).

The only element in your snippet (at least for the arm:* elements) where def:CommentOID can occur is on the <arm:AnalysisDatasets> element.
From the specification (read it!), page 26: "Usage: Conditional: Required if there is more than one analysis dataset needed to create the respective result" and "Description: Reference to the unique ID of a def:CommentDef element that contains the comment."

So you will need to have something like:
<arm:AnalysisDatasets def:CommentOID="COM.1">
<arm:AnalysisDataset ItemGroupOID="IG.ADEEG">
<def:WhereClauseRef WhereClauseOID="WC.T_8_2_1.ADEEG.R1"/>
<arm:AnalysisVariable ItemOID="IT.ADEEG.AVAL"/>
<arm:AnalysisVariable ItemOID="IT.ADEEG.CHG"/>
</arm:AnalysisDataset>
<arm:AnalysisDataset ItemGroupOID="IG.ADSL">
<def:WhereClauseRef WhereClauseOID="WC.T_8_2_1.ADSL.R2"/>
</arm:AnalysisDataset>
</arm:AnalysisDatasets>

and then of course have the comment itself, something like:
<def:CommentDef OID="COM.1">
<Description><TranslatedText xml:lang="en">..........</TranslatedText></Description>
</def:CommentDef>

o Oleksii
on July 19, 2019

Thank you, Jozef.

Sergiy
on July 19, 2019

Hi Oleksii, 

There is an example in CDISC ARM v1.0 standard specification document on page 14. There is also an example in sample define.xml included into CDISC ARM v1.0 standard package.

Note, that another example code on page 16 violates DD0094 rule.

Kind Regards, 

Sergiy

P.S. DD0094 rule is specified on page 26: "Def:CommentOID ... Required if there is more than one analysis dataset needed to create the respective result"

 

j Jozef
on July 19, 2019

As well Sergiy as the ARM-specification have a small typo on page 26:
it must be "def:CommentOID" instead of "Def:CommentOID". XML is case sensitive.

Lex
on July 21, 2019

Some clarification about the examples in the ARM specification. The examples in section 4 are not complete XML fragments with all required elements and attributes. Each fragment has a focus on a particular element. For example, the code that Sergiy mentions from page 16 is about the selection criteria (WhereClauseOID and def:WhereClauseDef). That is why it does not include arm:AnalysisDatasets/def:CommentOID and also not def:CommentDef. 

It would not make sense to apply all validation rules to every code fragment.

 

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