SDTM IG 3.1.2 Amendment 1

c ciani

on March 13, 2017

Hi,

I would like my data to be compliant with SDTM version 3.1.2 Amendment 1. I do not see this option in the P21 validator. If we use Configuration = 3.1.2 (FDA), will amendment 1 compliance issues be missed?

Thanks.

Forums: SDTM

b Brian

on March 13, 2017

Yes. This is old, but I…

Yes. This is old, but I assume still valid:

https://www.pinnacle21.com/news/opencdisc-validator-14-and-sdtm-313-validation

"* SDTM 3.1.3 replaces previously published SDTM 3.1.2 Amendment 1 rules. So if you are still on Amendment 1, please use SDTM 3.1.3 configuration to validate your data"

Brian