Dear Certara/Pinnacle 21 Support Team,
We are reviewing a Define.xml validation report and received the following findings:
DD0137 – Invalid variable label value
Variable: TSVAL1
Variable: TSVAL2
The rule message states:
“The value of an English variable’s description must match the one specified in the CDISC standard for an ItemDef element that represents a dataset’s variable defined as following an SDTMIG or SENDIG standard.”
In our TS dataset and metadata specification, the variables are currently defined as follows:
TSVAL1 – Parameter Value 1
TSVAL2 – Parameter Value 2
We also confirmed that these labels are present in the physical dataset metadata.
Could you please clarify what Pinnacle 21 expects as the valid English variable descriptions for TSVAL1 and TSVAL2 in the Define.xml ItemDef elements?
Specifically, we would like to understand whether TSVAL1 and TSVAL2 should have descriptions that include the continuation numbering, such as:
TSVAL1 – Parameter Value 1
TSVAL2 – Parameter Value 2
or whether Pinnacle 21 expects another description based on the CDISC standard.
Could you also advise what change, if any, should be made to resolve the DD0137 findings?
Best regards,
José