1.4.1 validator: custom Events domain has dubious errors for SD0056 and SD1073

Pinnacle 21 Support SDTM
1

Hi Joan,

  1. –DECOD variable has been already set to Permissible in Custom Events domain specifications as you suggested.

  2. –OCCUR and --STAT variables in SDTM IG 3.1.3 specs had incorrect “Prohibited” attribute value. We are fixing it now.

  3. I did not find anything wrong with --PRESP variable. Could you provide more details on used specification profile? Is it SDTM 3.1.3, 3.1.2 or 3.1.1?

As a temporary solution until a release of new version of OpenCDISC you can fix this issue manually by editing specification files. E.g.,

  1. find in in “…/config” folder a file “config-sdtm-3.1.3.xml”, make a back-up copy, then open original specs file by xml or simple text editor

  2. search for

(it’s row #1098)

  1. replace val:Core attribute value to “Permissible” :

  1. do the same with EVENTS.OCCUR and EVENTS.STAT

  2. save changes

Thank you for reporting your findings!

Sorry for inconvenience.

Kind Regards,

Sergiy

2

Hi Sergiy,

The fix you are making sounds like it should be all the fixes that would be needed for these kind of issues. No false warning came up for --PRESP at all. The only false errors that we were encountering for the domain were for --DECOD and --OCCUR.

So this should suffice.

Thank you very much.

  • Joan
3

Hi,

In the same kind of custom Events domain, a warning flag for a missing variable column for --ENDTC comes up. However, like in domain MH, all these kind of timing variables would be permissible; they are not expected.
Does it make sense?

Thanks,

Joan

4

Hi Joan,

It has been already fixed.

E.g., now in custom domains only STUDYID, DOMAIN, (USUBJID/POOLID), --SEQ and --TERM variables are Required by the validator. EPOCH and --STDTC are Expected.

Thanks,

Sergiy

5

Hi,

It’s for a custom Events domain, let’s call it XE. The validator complains that XEDECOD would be a required variable, and it’s not found; SD0056. (We have --TERM, and we don’t use --DECOD. That should be permissible, just like it is permissible in MH.) I think this is a bug.

Second issue. We have --PRESP and have --OCCUR. We are getting SD1073, that XEOCCUR is variable prohibited for use in SDTM. Again, I think it is a bug for the custom events domain.

The validator flag occurred with or without define.xml file. Same either way.

With the 1.3 validator, these flags do not come up for the same domain. Can you let me know your opinion, and if it would be addressed?

Thanks very much!

  • Joan