Forums: Validation Rule Suggestions
Hi Bruce,
1) See http://www.opencdisc.org/forum/removal-sd0081
2) These new checks were not included into FDA document, but they are expected to be added in updated version of FDA document. These new checks are run by FDA DataFit (OpenCDISC Enterprise). OpenCDISC Community validation specifications are executable version of FDA official business rules. Please remember, that you are still responsible for quality of your submission data.
3) Yes, checks SD0093, SD1003 are the similar to SD2021, SD2022. Difference is in presence of additional AGETXT variable in SDTM IG 3.1.3+ versions.
4) It's covered by algorithm of SD2265 check which has incorrect FDA ID. It will be fixed in the next release. Thanks for reporting!
Kind Regards,
Sergiy