SD1212 behaving differently for FDA versus PMDA checks

d David

on January 5, 2016

I have a record where xxSTRESC = 01 and xxSTRESN = 1. For another record, I have xxSTRESC = 080 and xxSTRESN = 80. I do not believe this is an issue, as I have seen data like this many times before and it’s never been flagged in previous OpenCDISC releases. When selecting the 3.1.3 FDA checks in Community 2.1.0, this is not flagged as an issue. However when I run the validation using PMDA 3.1.3 checks, SD1212 does state that this is an issue where xxSTRESN does not equal xxSTRESC. Is this an issue with the PMDA checks, or was this intentional?

Forums: SDTM

b Brad

on January 6, 2016

Checks Removed

Hi David,

SD1212 was intentionally removed from the FDA configs because the FDA has not evaluated it yet. This check might be added back in the future, pending the FDA's decision. You should expect to see some difference between FDA and PMDA configs.

As noted in the change log:
Removed 16 rules, which may be re-introduced in future: SD1132,SD1202,SD1203,SD1204,SD1205,SD1206,SD1207,SD1208,SD1209,SD1210,SD1212,SD1213,SD1223,SD2237,SD2238,SD2239