Define.xml

We noticed that when we validate define.xml without xpt data, the report contains DDxxxx checks that report issues with define.xml correctly but when we validate the same define.xml with xpt data the same DDxxxx checks no longer appear in the report.

for example the below issues are reported only when define.xml is checked :

Hi,

we are getting the error message DD0084: Referenced File is missing - for all datasets xpt files and documents referenced in the define.xml. The files are located in the same directory as the define.xml. All links in the define.xml work properly, i.e. all files can be opened using the hyperlink.

The leaf definition e.g. for TS is as follows:

           <def:leaf ID="LF.TS" xlink:href="ts.xpt">
               <def:title>ts.xpt</def:title>
            </def:leaf>

I've discovered an issue with the validation of the variable order in the SE domain under SDTMIG 3.2 (model v1.4). 

Looking at the SDTM 3.2.xml configuration file, the timing variables in SE are ordered VISIT, VISITDY, TAETORD, EPOCH, SEDTC, SESTDTC, SEENDTC, SEDY, SESTDY, SEENDY, which matches the order from table 2.2.5 ("Timing Variables for All Classes") of the v1.4 model.

Hi everyone,

If I were to extend an extensible codelist I understand how to work with the tags to identify an extended value, but say what if I have this certain tag structure in the ARM:

<arm:AnalysisResult

OID="AR.Table_14-3.01.R.2"

ParameterOID="IT.ADQSADAS.PARAMCD"

AnalysisReason="SPECIFIED IN SAP"

AnalysisPurpose="NEWLY SPECIFIED PURPOSE">

</arm:AnalysisResult>

How do I make a valid extension to the ADaM Controlled Terminology?

Thanks,

Andy

Hi!

If I have a SUPP-- Domain with only one QNAM, then why do I need a VLM on QVAL? In case of one QNAM I can map QVAL accordingly.

Thanks in advance!

Hi...first...THANK YOU SO MUCH for this tool. Creating the DEFINE.XML is the task I dread most! I was wondering if you can tell me what column I need to populate to get my derivations/mapping to output in the DEFINE document? In the EXCEL spreadsheet, I put them in the COMMENTS column, but they do not transfer to the COMMENTS/DERVATIONS column in the define. I did open up the code and I see that they are read in, they just don't output. Is there a trick to doing this?

Hi,

I have a question about AD0130 rule(Inconsistent value for BASEC). Here is the rule:

"Within a study, All BASEC values must be the same for each unique value group of [PARAMCD,BASE] when PARAMCD, BASE and BASEC are populated. (ADaM IG v1.0 p.28: There must be a one-to-one map between BASE and BASEC within a given PARAM if BOTH are populated)."

See the example below in my data, I understand the issue for AVAL and AVALC, but my question here is for BASE and BASEC. Why validator complain BASEC? The values of BASE and BASEC are indeed one on one match.

I would like to see an example define.xlsx and some written documentation on how to populate its various work sheets.  Any help in this area would be very welcom

Hi,

I ran Pinnacle 21 coummunity 2.1.3 for SDTM define, and got the DD0039 error(Variable is in wrong order within Dataset 'XX') for following variables: AE.AELLT, MH.MHLLT, DM.RFXSTDTC, TS.TSVALNF. However, I checked the variable order on SDTM 1.4 SDTMIG 3.1.3. We followed the correct order:

     For RFXSTDTC, it is STUDYID, DOMAIN, USUBJID, SUBJID, RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC.....;

     For AELLT and MHLLT, the order is STUDYID, DOMAIN, USUBJID, --SEQ, --GRPID, --REFID, --SPID, --TERM, --MODIFY, --LLT, --LLTCD.....;

Hi,

I have faced similar issue in previous version V2.1.3 as well. When I generate define through Pinnacle 21 V2.2.0, it does not generate CRF page numbers.

This bug should have bee handled in new version but not.

Regards,

Sachin