DD0099, DD0100 - Analysis Reason & Analysis Purpose

Sergiy

on July 6, 2020

P21

See recently introduced CDISC CT for Define-XML

Hi Gopal, 

This terminology was moved to recently introduced CDISC CT for Define-XML. See https://evs.nci.nih.gov/ftp1/CDISC/Define-XML/

Kind Regards,

Sergiy 

DD0099, DD0100 - Analysis Reason & Analysis Purpose

Thanks for sharing additional details.

We have SDTM, ADaM & SEND P21 terminologies in the website [https://www.pinnacle21.com/downloads/cdisc-terminology].

Will Define xml terminologies for P21 be listed in the same P21 website?

We can include CDISC CT for define xml & populate NCI codes in the study define xml, but while validating xml with P21 V2.2.0, we are getting DD0099, DD0100 messages, because we don't have define xml terminologies incorporated in P21 V2.2.0. Please correct me, if I misunderstood.

Thanks in Advance.

DD0099, DD0100 - Analysis Reason & Analysis Purpose

Hi,

We are getting DD0099 & DD0100 / FDAB035 messages while validating define xml ARM section with P21 3.0.2 Community version. 

As per previous discussion, CDISC CT for Define-XML moved separately.

Would like to know, whether this is incorporated in P21 V3.0.2 checks or not.

If not then how to validate ARM Section code list values [Analysis Reason & Analysis Purpose] against CDISC CT? Please suggest.

Thanks in Advance for your inputs.

Sergiy

on September 4, 2020

P21

Hi Gopal, P21 Community 3…

Hi Gopal, 

P21 Community 3.0.2 still has this issue. For validation of Define.xml file with ARM I would recommend you to utilize ADaM CT 2019-03-29 which is the last version with codelists for Analysis Purpose and Analysis Reason.

Sorry for inconvenience,
Sergiy 

DD0099, DD0100 - Analysis Reason & Analysis Purpose

Thanks for your valuable inputs and confirmation.

Pinnacle warnings - DD0099, DD0100 for ARM Define.xml

I got these Pinnacle warnings, DD0099, DD0100 for ARM Define.xml. I tried to use Define CT values like "Analysis Reason", "ANLREAS".

When I used the value, 

• "Analysis Reason" instead of "AnalysisReason",  I am getting xml syntax error. (Element name can not have a blank space in between)
• "ANLREAS" instead of "AnalysisReason", Pinnacle is expecting the value to be "AnalysisReason".

Please suggest how to apply Define CT in ARM xml code. 

Below is the ARM xml syntax for an example table. 

arm:AnalysisResultDisplays>
<arm:ResultDisplay OID="RD.14_2_1_2_1" Name="Figure 14.2.1.2">
<Description>
<TranslatedText xml:lang="en">Duration of Response (DOR) in XYZ</TranslatedText>
</Description>
<def:DocumentRef leafID="LF.14_2_1_2_1">
<def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
</def:DocumentRef>
<arm:AnalysisResult
OID="AR.14_2_1_2.R.1"
ParameterOID="IT.ADTTE.PARAMCD"
AnalysisReason="SPECIFIED IN SAP"
AnalysisPurpose="EFFICACY OUTCOME MEASURE">
<Description>
<TranslatedText xml:lang="en">Kaplan-Meier plot of duration of XYZ</TranslatedText>
</Description>
<arm:AnalysisDatasets>
<arm:AnalysisDataset ItemGroupOID="IG.ADTTE">
<def:WhereClauseRef WhereClauseOID="WC.FIGURE.14_2_1_2"/>
<arm:AnalysisVariable ItemOID="IT.ADTTE.AVAL"/>
</arm:AnalysisDataset>
</arm:AnalysisDatasets>
<arm:Documentation>
<Description>
<TranslatedText xml:lang="en">Duration of Response (DOR) in XYZ</TranslatedText>
</Description>
<def:DocumentRef leafID="LF.sap.1">
<def:PDFPageRef PageRefs="21  38" Type="PhysicalRef"/>
</def:DocumentRef>
</arm:Documentation>
<arm:ProgrammingCode Context="SAS version 9.4">
<arm:Code>
ods output survivalplot=tsurv_ homtests=tlogrank(where=(test='Log-Rank'));
 SAS CODE
</arm:Code>
<def:DocumentRef leafID="LF.FIG_14020102_dor28_itt.1" />
</arm:ProgrammingCode>
</arm:AnalysisResult>
</arm:ResultDisplay>

Pinnacle warnings - DD0099, DD0100 for ARM Define.xml

Maybe you should read the Define-XML specifications first ???

You can find them at: https://www.cdisc.org/standards/data-exchange/define-xml
Click on "Versions", select the version you are working with, and act accordingly.