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SDTM/dataset variable label mismatch
Sergiymost likely we'll not include Variable Label check in SDTMIG 3.3
Hi Sahil,
It's still under discussion. P21 validation is often criticized to have extra rules. Community validation is limited to CDISC and regulatory agency submissions needs. Variable Label check is an example of rules some people do like to comply with. CDISC always has some minor errors in their specs, and decided to lower their liability by removing Variable Label rule from their "SDTM minimal compliance" list. Similar to CDISC, P21 also has some minor bugs. Overall, most users want to have less potentially reported problems with their implementation.
Enterprise clients have alternatives to SD0063 rules available in P21 Define.xml, Standards Management and MDR tools.
That's why most likely we will not include Variable Label check in SDTMIG 3.3+.
The only exception is NMPA validation. Translation of CDISC dataset and variables names are required by the agency. So, we plan to add SD0063 rule to NMPA validation in the next engines.
Kind Regards,
Sergiy
As per Validation Rule SD0063 SDTM variable label not validating with the IG when we are validating through SDTMIG 3.3 or 3.4, Is there any planning to apply this validation rule for IG 3.3 & 3.4 in upcoming engine?