SDTM

Any reason why check SD0081 (--DTC date/time occcuring after latest disposition date) has been removed in Validator 1.5?

Hi,

This is regarding rule SD1047, Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record.

Is there any particular reason for this check?

Because as per SDTM Ig EXDOSE: Amount of EXTRT administered or given. and EXDOSTXT: Dosing amounts or a range of dosing information collected in text form. Example: 200-400.

Hi,

I ran OpenCDISC 1.5 on some SDTM data we received from a CRO, and SD1203 popped up since PPDTC was after RFPENDTC.  I don't usually see PPDTC populated, but it seems they were strictly following the IG where this is "Date/Time of Parameter Calculations", which I assume was the date on which the PP calculations were done by the PK group.

Should SD1203 apply to PPDTC, as it seems plausible to have these calculations done after the subject ends participation in the study?

Thanks,

Brian

I have an example of a variable containing only one character (which is "bad") in LBORRES that this check does not produce results.  See report attached. Record 1 and 5 contain the single bad character, records 2-4 and 6-8 are examples that this check catches when the bad character is at the beginning, middle and end.  I am using validator 1.3

What is SD0040 based on and why is CAT-SCAT not included in the logic as some domains like QS that have so many?

Hi, Can this check be updated to exculde records with missing dates (to account for Not Done assessments)? I checked config files and it is supose to exclude records with STAT=NOT DONE but did not see any thing in the code for this. I think it would be better to create exception for missing dates.

Thanks,

Nitin Patel.

Dear All,

I have a comment about rule SD1087 being used to check the SE domain.  Based on my understanding of the SDTM IG, I don't believe this rule should be applied to SE data because SE is a special-purpose domain.  From my understanding, additional timing variables cannot be added to the SE variable list, just as additional variables cannot be added to the DM domain.   

It seems I got this error message whenever there are multiple LBTEST for one LBTESTCD.

For example, LBTESTCD='EPITUDE', LBTEST='Renal Tubular Epithelial Cells', I would get 'CT0082R' saying "LBTEST and LBTESTCD values do not have the same Code in CDISC CT", but according to CT, we do have this value defined. Please help!

Hi!

As far as known the labels should be less than 40 characters. Why does HODECOD has a label with 52 characters (Variable Label = Dictionalry-Derived Term for the Healthcare Encounter).

Thanks in advance!