SDTM

Hello,

I am getting CT0169 and CT0170 error in OpenCDISC QSTESTCD and QSTEST are not using CT however values look identical. My values are as follows:

QSTESTCD = 'BARS0101' QSTEST = 'BARS01-Objective'

QSTESTCD = 'BARS0102' QSTEST = 'BARS01-Subjective, Awareness'

QSTESTCD = 'BARS0103' QSTEST = 'BARS01-Subjective, Distress'

QSTESTCD = 'BARS0104' QSTEST = 'BARS01-Global Clinical Assessment'

Hi,

Please let me know which version of SDTM terminology is using for define.xml validator in OpenDISC V1.5 and in which folder the SDTM terminology file is present.

Thanks,

Bhaskaran

Hi, I've been trying to validate a test database and I've just come across the rule SD0009: "No qualifiers set to 'Y', when AE is Serious".

I'm using SDTM IG 3.1.3 and I can't find this referenced there - can someone tell me where it comes from?  And whether it's mandatory or just recommended, as the qualifiers are not something we'd normally collect?  (It gives a Warning rather than an Error.)

Thanks!

I have three FA domain and in those DOMAIN value set to FA. what should be the value for Rdoamin in RELREC. currently I setted to FAxx but then I am getting SD0072 error.

Thanks & Regards

Deepali

 

Hi, I am validating domains along side the define.xml. In the define.xml, I added a term to the CMROUTE controlled terminology list since it is extensible. I added the term "OTHER" and included it in the define.xml but when I run the validator with both the domains and define.xml I still get CT0031 that states "Route of Administration (--ROUTE) variables values should be populated with terms found in 'Route of Administration' (C66729) CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.".

The TAETORD labels in the SDTM Metadata 3.1.2.csv file (data folder) are generally incorrect. They're correct in the TA domain, but not the other domains. In most other domains, the word Element is plural but should not be. In at least one domain, (EX) the word Planned is missing. Please check - thanks very much.

v1.5 of OpenCDISC is generating a CT0086 error message for the PC domain variable PCORRESU. It appears to me that it's using the wrong code terminology to check the variable PCORRESU.  Instead of using the UNIT code terminology to check, the error message indicates that OpenCDISC is using the PKUNIT code terminology.  Same applies to PCSTRESU and error message CT0087.

Dear Open CDISC:My plan is to use AP domains back-leveled to abide by SDTM 3.1.3 data structure conventions. This means that APAE would look like AE with all the "newer variables" introduced by CDISC in SDTM 3.2 defined as suppquals.What class do I use. I tried using the EVents class but the OpenCDISC Validator does not recognize the four characater domain code. ThanksJoyce

using opencdisc 1.5 and config-sdtm-3.1.2.xml I get errors for tumor domains TU, TR, RS saying --EVALID, --ACPTFL are not in the SDTM standard.

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