SDTM

I suppose the text for rule SD0074 in SDTM 3.1.2 should be corrected as the check just goes for the Domain name, not for the variable:

Identifies Supplemental Qualifiers domain reference to a key variable that isn't defined in the target domain

It seems that the Description texts for the rules SD0090 and SD0091 in the configuration for SDTM 3.1.2 have been swopped.

It seems that rule SD1004 in SDTM 3.1.2 wrongly is checking for the max length of the ARMCD variable to 40 characters. Should be 20. 

Hello

I am not sure if the rule SD0031 can be modified or not. However within the PC domain there is a variable PCDTC which is the date of the specimen collection and PCENDTC which is the end date. When ENDTC is present the program seems to look for a STDTC value. But this is not an allowable variable in the PC domain just PCDTC. So we have data like this below:

PCDTC                      PCENDTC

Hi,

I downloaded the new SDTM Terminology.txt from http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ and added it in the folder
C:\OpenCdisc\opencdisc-validator\config\data  (and renamed the old to SDTM Terminology_old.txt)  Then I started the Open CDISC and submitted a study, but in the result file I got the message that several rules couldn't be performed due to that they couldn't find the SDTM Terminology.txt, e.g.

Hi,

It looks like warning CT0023 ('Variable values should be populated with terms found in 'Anatomical Location' (C74456) CDISC controlled terminology codelist') fires when you use the special value MULTIPLE in AELOC, as described in the SDTM implementation guide section 4.1.2.8.3. Is this a bug or is it a deliberate decision to flag a warning?

Thanks,

Martin

Hello All

I hava a question Regarding the Rule ID SD1001. This rule specifies duplicate Subjects within a speciifc study. How would you consider the the above rule for Integration data (ISS). We always  expect duplicates across multiple studies and the Validator results show this as a High Severity Error. Any suggestions how we can prevent the occurance of this error in Integrated data.

It seems that the validation definition for the SD1013 rule in config-sdtm-3.1.2.xml has been made opposite to the intention.

 Test="TAETORD != ''"

should be changed to

 Test="TAETORD == ''"

Hi,
I am attempting to validate that some required supplemental variables are provided in a dataset. How do I validate this vertical data where the variables appear as variable values?

Regards,
Rickard

Hi

For validating SAS transport datasets, do you support a single xport file with multiple datasets or do they all have to be separated into separate datasets (e.g., dm.xps, lb.xpt, etc.)

thanks in advance!

-greg