SDTM

Hello,

Our medical history data record is quite simple and only includes: free-text Mddical history term and Past/Active status,

Therefore, I create the MH.xpt includes variable subject's MHTERM record with MHSTDTC and MHENDTC are blank.

When I validate MH.xpt, it shows warning:

SD0021: --ENRF expected when --ENDTC is null

Hi,

I am under the impression that result qualifiers, eg. LBORRES, CMDOSE cannot be used to generate xxSEQ, but I am unable to find this in the IG. Am I correct?

Thanks,
Matt

Update, managed to locate this in section 4.1.2.8.2. of the IG for result qualifiers (findings class), but have not come across anything for record qualifiers, e.g. CMDOSE (interventions class).

Hi,

I was wondering what the advantages are of using the defineXML option when running SDTM XPT files through openCDISC?  I have tried running the XPT files both with and without the defineXML option being used and i seem to get the same results.

Thanks.

Hello,

the data files for OpenCDISC contain a variable DVGRPID for 3.1.1. and 3.1.2. But this variable does not occur in the SDTMIMG. So is this an error, and whose error is it? Is DVGRPID legal?

Hello All 

I ran the latest version of validator and came across this error SD0002 in PC domain. When the STAT variable is not Done PCSPEC is not populated. Do I need to populate it even when the test is not done.

Thanks

Arun

Hello,

Hi

Noticed a possible problem with rule SD0013.

Identifies records that violate the condition [(Start Date/Time of Observation less than or equal to End Date/Time of Observation)], limited to records where [Start Date/Time of Observation is not null and End Date/Time of Observation is not null]

This check fires for data I consider to be valid e.g.:

CMSTDTC = 1990, CMENDTC = 1990-09

CMSTDTC = 2010, CMENDTC = 2010-11-27

Can this be fixed by changing the when= in config or is it a problem with how the @lteq operator is programmed?

Hi,

I am getting this warning for the CM domain:

"Start date expected when end date provided

SD0031: Identifies records that violate the condition [Start Date/Time of Observation or Start Relative to Reference Period is not null], limited to records where [End Date/Time of Observation or End Relative to Reference Period is not null]"

The rows that are provoking it look typically like:

Hi,

I noticed that in OpenCDISC version 1.1, the CDISC Controlled Terminology is based on release 4/8/2010. However, a newer version of the CT exists, which is dated 1/7/2011. Therefore, does the new CT get updated for 1.1, or will this have to wait until the next version?

Thanks

I ran SDTM checks on my datasets where i have custom datasets. Since the custom dataset names would not be in the SDTM CT for DOMAIN, these DOMAIN values should pop-up as issue, but I could not find these.

For your CT checks, are you doing any different for extensible CT? I am assuming it is reporting any code values which do not match to SDTM CT irrespective of the extensibility of the CT. Is this true?