Question on creating a custom domain

j Joyce

on July 16, 2014

Dear Open CDISC:My plan is to use AP domains back-leveled to abide by SDTM 3.1.3 data structure conventions. This means that APAE would look like AE with all the "newer variables" introduced by CDISC in SDTM 3.2 defined as suppquals.What class do I use. I tried using the EVents class but the OpenCDISC Validator does not recognize the four characater domain code. ThanksJoyce

Forums: SDTM

s Sergiy

on July 16, 2014

Hi Joyce, Unfortunately now

Hi Joyce,

Unfortunately now OpenCDISC does not support AP domains. So far we did not see any significant interest from our users in this area.

Kind Regards,

Sergiy

v Verna

on June 24, 2015

AP-- domain(SDTM v1.4)

Hi,

I am intending to using APMH domain as we collect data on family history. I noticed that the AP is correspondent to version 1.4 of SDTM. By that mean, can APMH domian still be used when all the other domian are using version 1.3(iG 3.1.3)?

Furthermore, as FDA has not approve SDTM v1.4( IG3.2, by that mean, we can not submit dataset with SDTM v1.4 ?