Query Regarding Label Updates for COVAL and TSVAL Variables

l Lu

on November 25, 2024

We have observed that engine FDA 2304.3 and engine PMDA 2311.0 have updated the variable labels for COVAL1-COVAL10 and TSVAL1-TSVAL10. Currently, these labels are aligned with those of COVAL and TSVAL, which appears to be in accordance with the guidelines in SDTM IG3.3, specifically section 4.5.3.2 . These guidelines apply to datasets such as CO, TS, TI, TE, IE, and SUPP.

However, when modifying based on QLABEL, we are still encountering the error: "Inconsistent value for QNAM within QLABEL."

Could you please confirm whether this issue will be addressed in post-P21 updates?

In previous discussions（Inconsistent value of QNAM within Qlabel | Pinnacle 21）, you have provided responses to similar queries. As CO and TS labels have already been corrected, the previous rationale is no longer applicable. To maintain consistency across projects, would it be appropriate to address the error in the SUPP dataset as well?

Your guidance on this matter would be greatly appreciated.

Thank you for your attention to this issue.

Best regards,
Yi

Forums: SDTM

j Justin

on December 3, 2024

P21

RE: Query Regarding Label Updates for COVAL and TSVAL Variables

SD1130 is checking for a one-to-one relationship. Our SME team has reviewed this occurrence recently and it was determined that it wasn’t possible to update these rules to differentiate between multiple values for a parent variable vs when text strings are >200 characters. Since this case seems to be an exception to the rule, we recommend following the approach taken in the SDTM-IG and explaining in the cSDRG when SD1130 is triggered. To address this, we have added a new Fix Tip for this scenario in our 2405.0 Engine release, however, this fix will only impact P21 Enterprise at this time as this Engine version is not available in Community and Fix tips are not included.

The fix tip explains that if this rule is firing for suppqual variables created specifically to contain values past the 200th character of text from a variable in the parent domain, this can be explained in SDRG to note this particular application of SDTMIG guidance.

Kind regards,

Justin