Variable in wrong order in FA

a Abdul

on November 11, 2016

I am creating FACE domain, I get a warning that FDA expected EPOCH variable is absent. When I added it, I kept this column far right in the dataset as there is no EPOCH variable mentioned in IG under FA. Now when I have added it, I got another warning regarding variable order is incorrect. I also have FAORNRHI variable which we would need to submit for which i have similar warning.

Could you please suggest what should be location of EPOCH & FAORNRHI in FA domain.

Thanks in Advance.

Forums: SDTM

s Sergiy

on November 11, 2016

For order of variables, refer to SDTM Model, not IG

Hi Abdul,

Order of variables is defined by SDTM Model.

SDTM IG follows this order, but is limited to only some selected variables.

Please refer to SDTM standard, rather than IG.

Kind Regards,

Sergiy

a Abdul

on November 28, 2016

Thanks for information…

Thanks for information. Could you please let me know any link which gives more information with regards to SDTM standards.

j Jozef

on November 28, 2016

Order of variables

http://www.cdisc.org/standards/foundational/sdtm and look for document "Study Data Tabulation Model v1.4" (so NOT the Implementation Guide). You need to register just once if you have never there before or use your CDISC account.