SDTM

Description

Technical support questions about SDTM standard and validation rules

August 13, 2012

 

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"

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July 20, 2012

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. 

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July 19, 2012

No issue

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July 11, 2012

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

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June 22, 2012

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!!!!!!!

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June 20, 2012

Hi,

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

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June 13, 2012

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."

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June 4, 2012

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

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May 24, 2012

Hello.

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

Thanks,

Nalin

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May 23, 2012

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"

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