SDTM

Dear OpenCDISC team:

I just ran into this problem with MI (Microscopic) domain.  I had some Immunohistchemistry data which reports a stain intensity score. It has no units.  Error message indicates the expectation of units.  Please refer to page 4 and 5 MI Section 6.3 for examples in SDTM IG 3.2. 

Dwar All: I am getting the following error message. Validation for the IE domain never completes. It never presents the Domain Error Report. To help us debug this exception, please provide the data below --------- System Information --------- Version: 1.5 JRE: 1.7.0_60 OS: Windows 7 6.1 x86 -------------------------------------- org.opencdisc.validator.data.InvalidDataException: The variable must only appear once at org.opencdisc.validator.data.AbstractDataSource.getVariables(AbstractDataSource.java:112)

We have recently been getting warnings when running OpenCDISC validator for Rule ID SD1118, with a message ‘Neither DSSTDTC nor DSSTDY are populated’. The warnings are occurring on data entered into a form in our eCRF library. The form is designed in such a way that a date is only completed under certain circumstances and dependant on replies to other questions on the form. Our internal groups have confirmed a date being recorded on the current form for every subject would not be required for any of our analysis or reporting.

The Open CDISC 1.5 configuration file does not contain AP domain structures. Should we modify the configuration file to add AP structures as a custom domain? Thanks,Joyce

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.