SD1203 not working for FDA checks

Pinnacle 21 Support SDTM
1

Hi David,

SD1203 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
2

Hi Per the comment: 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.

Can someone point me in the direction of the change log? I can’t find it.

Thanks,

PDL

3

…\components\config\CHANGELOG.txt

See “SDTM 3.x … (released 11-Dec-2104)”

4

When selecting the PMDA 3.1.3 checks, SD1203 is correctly flagging DADTC dates after RFPENDTC, and also correctly flagging xxDTC dates in a custom findings domain as being after RFPENDTC. However when the FDA 3.1.3 or 3.2 checks are selected, SD1203 is not showing this same issue. Also when I go to the “Rules” tab, SD1203 is not listed out. Has this check been removed from the latest Pinnacle 21 Community 2.1.0 release?