error in SD1039 in v1.4

Pinnacle 21 Support SDTM
1

Hi Vanessa,

The SD1039 looks OK! It was designed to be applied across all domains of three general classes. The implementation algorithm includes checks for --TRT, --TESTCD, --TERM variables, but those variables are specified as “optional”. Therefore in a Finding domain LB the algorithm works only with a LBTESTCD variable and it does not care about “LBTERM” and “LBTRT”, because those variables are not present in Findings domains.

Thank you for sharing concerns about some potential problem! Please let us know if SD1039 check produces false-positive messages or does not catch real data issues as intended.

Kind Regards,

Sergiy

2

Hi,

I think there is an error with rule SD1039 in openCDISC v1.4.

LBTERM, LBBODSYS, LBTRT, LBTESTCD, DOMAIN, LBCAT

‘Redundancy in paired variables values’ -

Value of Category (–CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (–TERM); Name of Measurement, Test, or Examination (–TESTCD); Name of Treatment (–TRT); Body System or Organ Class (–BODSYS)

It was fired in a finding domain LB and I don’t think we have LBTERM in LB :slight_smile:

Would you please verify.

Thank you.