SDTM

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

Hello team,

I think I got a false positive based on an incorrect version of the 3.1.1 Config file. The SU domain config file shows that VISITNUM has the Label "Visit Name" but it should really be "Visit Number". 

Also in the config file VISIT has the Label "Visit Number" but it really should be "Visit Name"

See below

I'm getting this error because I have records in DM with ARMCD != SCRNFAIL/NOTASSGN and also not in TA.

However the SDTM implementation guide seems to suggest this is permissable in trials with multiple branch points, e.g. see Example 7 p63 / section 7.2.4.2 on p238.

Should this be a WARNING instead?

Cheers

Martin.

Hello Team,

I got this error message:

EG        TYPE, VARIABLE    Char, EGLOINC    SD0055    SDTM/dataset variable type mismatch

However, when I look in the eg.xpt file at the metadata EGLOINC is character.

EGLOINC    Char    10    10    $10.    .    LOINC Code

David

Running the latest validator program I got this error message for the EG domain using SDTM V 3.1.2

"Value for EGSTRESC not found in EGSTRESC controlled terminology codelist"

The records that were highlighted were the direct copy of measurements from EGORRES to EGSTRESC. This may be a false positive result.

I noted in the SDTMIG that generally the assumption is that any value in --ORRES should be derived or copied into --STRESC. So flagging numeric values for the ECG intervals of 62 msec seems to be a false positive.

Can someone clarify this?

Thanks!