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DD0039 on AE.AELLT, MH.MHLLT, DM.RFXSTDTC, TS.TSVALNF

j Jenny
on October 23, 2016

 

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.....;

     For TSVALNF, the order is STUDYID, DOMAIN, TSSEQ, TSGRPID, TSPARMCD, TSPARM, TSVAL, TSVALNF, TSVALCD, TSVCDREF, TSVCDVER

OpenCDISC community 2.0.2 DIDN'T complain. So I wonder if it is the bug for Pinnacle 21 community versions?

Thanks,

Jenny

 

Forums: Define.xml

s Sergiy
on October 25, 2016

Hi Jenny,

Are there any problems when using v2.2?

We support only the latest version.

Thanks, 

Sergiy

j Jenny
on October 27, 2016

Hi Sergiy,

I just run the v2.2, these warnings still there.

Thanks,

Jenny

s Sergiy
on October 27, 2016

Hi Jenny,

Could you send your define file to me to diagnose an issue.

Thanks, 

Sergiy

Sergiy (at) opencdisc (dot) org

g Gopalakrishna
on February 25, 2019

Hi Sergiy,

DD0039 - Variable is in wrong order within Dataset 'XX'.

While validating only define xml [P21 V2.1.3 and P21 V2.2.0], we are getting warning for following variables - AE.AELLT, DM.RFXSTDTC and MH.MHLLT.

SDTM datasets created based on SDTM IG 3.1.2 Amendment and going to submit FDA agency.

Variables populated as per SDTM IG specified order. Please confirm whether this is False positive message.

Thanks.

s Sergiy
on February 25, 2019

Hi Gopalakrishna, 

DD0039 and other rules (e.g., DD0059, DD0060) not directly related to Define-XML standard are removed in new upcoming Community release 3.0.0.

Define.xml file should describe structure and content of actual study data rather than be responsible for correct implementation of SDTM standard.

Kind Regards, 

Sergiy

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