SDTM

I have a custom check that matches AE and DS on USUBJID.  I want to check that for a given value of DS.DSDECOD there is a specific value set for AE.AEACN.  However I don't think there are any USUBJID values in common withe these combination but what I get out of the report is all the values in DS that match the criteria in DS, just as if I hadn't put the cross reference lunk to AE.

Is this something openCDISC just can't do, or am I missing something here? I've copied the text of my rule below.  I'm running v1.4 downlaoded today.

I'm running OpenCDISC Validator v1.4, using the 3.1.3 config file, against a SUPPPC XPT data file.  The report generated indicates the error SD0086 "SUPPQUAL duplicate records" in the data.  I've looked at the data and there are no duplicates in the SUPPQUAL data for the variable combination in the report.  I've attached a subset of the data that duplicate this problem and should allow you to see the same.

Hi,

In our sponsor defined domains/sponsor defined added variables we get this error telling that the type does not match between the dataset and the define.xml. As far as we can see it does, but are there something other than just type/length this check does?

KR Marianne Carames

I get this error for duplicate subject, AEDECOD and start date

I have a question around the SDTM rule SD1011 for time duration.  Some of the records in the MK domain are being flagged "Invalid ISO 8601 value" for the MKDUR variable (i.e. values: PT360.0S, PT2.4S, PT2.3S, PT3.7S). The source data is muscle testing (MK domain) and it does collect very accurate measurements to the 10th of a second.

For the screening failures a disposition date (DSDTC) may exist, but since the DSSTDY is calculated based on reference date (RFSTDTC) from DM, which is missing for screening failures, a warning is issued. 

I think it should be ok to have a missing DSSTDY for screening failures.

KR Marianne

I just ran sdtm validation v 3.1.2 on the AE domain and got this error. But the data is not wrong as far as I can tell. The AE starts before the end date. Even the validation report seems to show this. Here it is

I just ran an SDTM validation for ver 3.1.2 and got a Duplicate AESEQ error. But this does not seem correct. I looked at the data and for this subject there are no duplicated AESEQ values.

Here is what the validator report shows:

I have one AE for one subject that has only a year for a start date (the same year that is in all of the start dates for the other AEs for this subject) and the last disposition date is a date in that same year.  This rule is firing for that one AE.

The checking rule SD1056 was changed in version 1.4:

"The length of IE Criterion Result variables (IEORRES, IESTRESC) is expected to be 2"

But the vaules of IEORRES & IESTRESC should be only "Y"/"N", does any reasons to modify the expected length to 2?