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Technical support questions about SDTM standard and validation rules
Hi Team,
We recently discovered this issue on OpenCDISCv1.3:
Our study has 4 split QS domains (e.g. QSAA, QSBB, QSCC and QSDD). Out of these four split domains, QSCC had no observations. All four domains were included in the OpenCDISC Validator run and the tool only reviewed domains QSAA and QSBB. It did not process QSCC and QSDD. We understand that QSCC was not processed as it was an empty domain, however we didn't realize that the tool would overlook/exclude the next valid QSxx domain.The tool reviewed QSAA, QSBB and QSDD after QSCC was removed from the "review list".
FA non-ordinal results can trip SD0026 false positive
for the condition "Missing value for FAORRESU, when FAORRES is provided".
In a study we have a test in FA domain for "Criteria for Staging"
with result values of: faorres = "1" fastresc = "Criterion 1 met"
For continuations, the split between COVAL and COVAL1 text will sometimes trip a warning if the continuation text block begins with a space. Should the first part of the rule that
"Character values should not have leading space ' ' characters or '.' as an entire value
be suspended / not applied for continuation fields, where absense of space would be run-together text?
Please consider and advise.
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
