Hi All,
This is Minji.
I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2.
A Rule ID CT2002 validation was run under Method CT for the QSMETHOD variable. It looks like QRSMTHOD CT should be applied.
Thank you for your help.
Best regards,
MinJi
Hi @minji.lee
Thank you for reporting this issue.
Currently in P21 specifications (METHOD) codelist is assigned to all —METHOD variable on Model level. So, when --METHOD variable is not included into specific domains of SDTMIG 3.3, it will inherit (METHOD) codelist from the Model. Our initial decision was based on a fact that all (~20) --METHOD variables in SDTMIG utilize (METHOD) codelist. The only exception is EGMETHOD.
SDTMIG 3.4 introduces (QRSMTHOD) codelist for FTMETHOD, QSMETHOD, RSMETHOD.
We will delete (METHOD) codelist assignment on Model level to solve this issue.
Decision about assignment of (QRSMTHOD) codelist for QSMETHOD variable in SDTMIGs prior to v3.4 is still under discussion.
I believe that Codelist is a property of variable and is not related to version of SDTMIG when it was initially introduced. However, some users prefer to have less level of standard compliance and request a formal approach to have codelist assignments per SDTMIG version.
Kind Regards,
Sergiy