This rule is popping up now in 4.0.0 for every SUPP domain. Even for the IDVAR and IDVARVAL for SUPPDM where SDTM IG 3.2 states: “IDVAR and IDVARVAL are null because the key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify a unique parent record in DM.” Should we be creating a DMSEQ and setting these SUPP values?
Also, for every missing QEVAL for SUPPS an issue is thrown. But the SDTM IG 3.2 states: "The observations recorded in the Findings class include the --EVAL qualifier because the observation may originate from more than one source (e.g., an Investigator or Central Reviewer). For the Interventions and Events observation classes, which do not include the --EVAL variable, all data are assumed to be attributed to the Principal Investigator. The QEVAL variable can be used to describe the evaluator for any data item in a SUPP-- dataset [Section 8: 8.4.1, Supplemental Qualifiers: SUPP-- Datasets], but is not required when the data are objective." Should we set all the values for QEVAL to "INVESTIGATOR" where the data was collected from the CRF?
* Required Field