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Clarification on the BLFL Warnings with Introduction on LOBXFL
Forums: Validation Rule Suggestions
Sergiypotentially applicable per Model
Hi Sri,
Our approach is to keep rules for any data structure where they are potentially applicable per Model.
For example, SD0006 (No baseline flag record in domain for subject) looks like been retired in SDTMIG 3.3+ due to introduction of new Expected variable --LOBXFL. However, in SDTMIG 3.3, 3.4 --BLFL is Permissible. So, if users does not include this variable in LB, VS, ... domains then SD0006 rule will not be complied and our validator will not produce false-positive messages. If for some reasons, users decided to utilize --BLFL instead of --LOBXFL in SDTMIG 3.3+ data, then SD0006 rule will do its expected job. For --LOBXFL, a new separate rule similar to SD0006 will be introduced. When CDISC remove --BLFL variable from the new SDTM Models, we will not assign SD0006 rule to all relevant IGs.
Similar approach with all other rules. For example, --STRTPT, --ENRTPT variables are not included into most domains in SDTMIG. However, they can be utilized as "model permissible" variables. So, if you use these variables, then all applicable rules will be complied and executed, rather than be assigned only to some selected domains where --STRTPT, --ENRTPT variables are "Permissible" per SDTMIG.
Kind Regards,
Sergiy
I was wondering whether you have any plans to update the validation rules on BLFL as it has now become permissible, and LOBXFL has been introduced. Moreover there are ongoing discussions suggesting that BLFL might be deprecated soon. How should sponsors handle BLFL vs. LOBXFL in SDTM datasets to ensure compliance with both current and future validation expectations? I appreciate any insights or updates on this matter!
Thanks
Sri