b Bruce


It is very useful that the rules and details tabs of 2.0/2.01 now give traceability to the FDA SDTM rules list v1. We did a deep dive and reconciliation and found some questions arising : 1) FDAC054 (Observation date is after the latest Disposition date for EG, LB, VS) does not appear to be in v2.01 configs. We see FDAC208 and FDAC050 that check dates in AE and EX but FDAC054 is missing. Have we identified this scenario correctly ? If so – is this intentional – we would like to understand why. 2) In 2.01 checks SDTM1202-1209 from 1.5 are now retired. These checks were useful to identify occasional aberrant dates across any domain with the DM reference dates. Along with issue #1 above this feels like a gap has emerged. Is there a plan to add a new check to the next release to check all domain dates against latest DS date ? This would be our preference and would also cover FDAC054 expectations as well. 3) FDAC199/FDAC189 are in FDA SDTM checks v1 list but not in OpenCDISC 2.01. Is this because FDAC194/195 actually do the same check and more ? Is this the correct rationale ? 4) FDAC286 – values from PCLAS should be from same dictionary record in NDF-RT for pairs in TSPARM(CD). We could not find this in 2.01. Do sponsors need to find a way to check this or will it be added in a future/next release?

Forums: Validation Rule Suggestions

s Sergiy
on April 14, 2015

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,


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