SD1076/FDAC031: Model permissible variable added into standard domain

March 19, 2015

Hi, This should not apply to any DY variables (not talking about VISITDY) since FDA wants to see day calculated for all date variables. I see warnings for SESTDY/SEENDY using v2.0 for SDTM v3.1.3


According to the SDTM-IG 3.1.3, adding SESTDY and SEENDY to SE is allowed, but surely not required (they do not appear in SE in the SDTM-IG). The FDA however (unfortunately) has another opinion: they always want to see the --DY too. This although --DY variables can easily and automatically be calculated by the FDA tools (from DM-RFSTDTC).

So in your case, I think an "info" message should still be supplied for the SDTM rule, but not for the FDA rule.