SDTM

Can I use Ph domain for pathology/histology info in oncology studies. Please suggest

When executing SD0014 rule in open CDISC tool we found that the rule doesnt fail for negative values for DOSE variables. But as per the description and error message provided the rule should fail when run for a dataset containing negative values for DOSE variable.

Kindly Help!!!!!!!

Hi,

It seems to me that OpenCDISC 1.3 is incorrectly using SDTM 3.1.2 variable label check for SDTM 3.1.1.

We have 4,000 records in DA, with DATEST="Number Dispensed" or "Number Returned". These records are flagged with Warning CT0007 because these two terms don't match targeted controlled terminology "Dispensed Amount" and "Returned Amount".

The SDTM IG states that DATEST should be "Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: Dispensed Amount, Returned Amount."

Hi, when runing Opencdisc for SUPPAE domain, there is an error on SD0072, saying

Hello.

I wanted to check what data-checks are performed if the .asc files are provided?

Thanks,

Nalin

Hello all,  I am a C# .Net developer and I want to launch the jar executable and return to IE the log file of the validation like the GUI interface client.bat works.  I tried doing the following for example: 

java -jar lib/validator-gui-1.3.jar -source "C:\raw_data\AIN457\AIN457F2208\cmed\current\aev.txt" -input 1 -config "C:\Applications\opencdisc-validator\config\config-sdtm-3.1.1.xml" -log "C:\Applications\opencdisc-validator\config\seanlog.csv"

Rules SD1057-SD1059 - Non-recommended variable length for certain TEST and related variable values - expects the variable lengths to equal the max allowable. This is inconsistent with the "CDER Common Data Standards Issues" request for field lengths to be adjusted to the max found in the field, in order to reduce file sizes. Rather than testing whether the field length equals the max, shouldn't the check be that the field length doesn't exceed the max?

Please note the Events class has been extended to include --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --BDYCD, --SOC, and --SOCCD.  It does not seem as if the extension is limited to AE (see pg. 3 amendment 1 list [vers 1.0 final]).  Since MH and CE terms can be MedDRA coded, should SD0058 be updated for Amendment 1?  As of now, it triggers a warning for MH and CE for the MedDRA hierarchy terms.   Thank you

Joan

The check for consistent value for LBSTRESU within a lab test LBTESTCD should permit differentiating by specimen type and method.  Note, if the differentiation has been allowed in a beta version of the configuration it is not yet available through a site update, or on the svn.opencdisc.org configuration source site for updates.  Thank you.