SD1076/FDAC031: Model permissible variable added into standard domain

n Nitin

on 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

Forums: SDTM

s Sergiy

on March 20, 2015

Hi Nitin, You are correct.

Hi Nitin,

You are correct. We'll fix it inthe next release.

Thank you,

Sergiy

j Jozef

on March 20, 2015

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.