SDTM

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 However, a newer version of the CT exists, which is dated 1/7/2011.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? 

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