Rule CG0067/FDAB006: Check all disposition events for DEATH presence or final disposition only?

[PolinaVyniavska]

Rule Description: When SS.SSSTRESC = "DEAD", the final disposition record must have DSDECOD ^= "DEATH".
Rule Cited Guidance: For example, if a subject's survival status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS.
In the current implementation, the rule checks whether DSDECOD = 'DEATH' in general.

Operations:
  - domain: DS
    group:
      - USUBJID
    id: $ds_dsdecod
    name: DSDECOD
    operator: distinct

Question: Should we change it to check the DSDECOD value with the max DSSEQ?

[eljanssens]

Hi @PolinaVyniavska
The rule description is something that has been created by a volunteer and is currently referring to a final disposition date even though the rule + description don't mention this (the cited guidance does but the rule is created based on that cited guidance, not vice versa). I would thus program the rule explicitly according to the condition + rule: Raise an error when SSSTRESC = 'DEAD' but a record where DSDECOD = 'DEATH' is not present in the DS dataset.
There is another rule that is checking whether the DS record with DSDECOD = DEATH has a date = DTHDTC in DM (CG0069). So this already covers that. The fact that is explicitly the final disposition record seems to be a gap in the conformance rules but checking disposition date versus DTHDTC already covers it somewhat.

I don't think that the current rule is checking everything. I would divide it to check: if SSSTRESC = DEAD, then there 1) must be a record in DS 2) that record should have DSDECOD = DEATH

[PolinaVyniavska]

Hi @eljanssens, it makes sense. If another rule checks for the death date, then this will check the death event presence in general. Then I won't change anything in .yaml and will wait for CORE engine bug fix to run validation. Thank you!