Hello. When I validated SDTM using the FDA (2508.1) engine and the SDTM-IG 3.4 (FDA) configuration in Pinnacle 21 Community Version 4.1.0, a CT2001 error occurred in the -ACPTFL of RS/TR domain. The message was as follows: TRACPTFL value not found in ‘No Yes Response (Yes only)’ non-extensible codelist.
However, according to SDTM IG V3.4, the -ACTPFL in the RS/TR domain has a NY CT, which differs from the MS/OE domain. The CDISC note for the MS/OE domain specifies that it is expected to be “Y” or null. However, there is no such note for the RS/TR domain. Please confirm whether this error will be resolved in the RS/TR domain.
Thank you for your help!
Best regards,
Minji