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?
yes, we will need to explain these issues in the guides.
* Required Field
False positives SD1149 CG0016
Surely do NOT create DMSEQ for not getting these message. Do NOT set QEVAL set to "INVESTIGATOR" to just satisfy the software. These clearly must be bugs.
I presume P21 will soon have to come with a bug fix.