version 2.1: Incorrect SDTMIG 3.1.3 Variable Labels

Pinnacle 21 Support Troubleshooting and Problems
1

Hi Thierry.

Your labels are correct as you said. We will be releasing a patch update that contains fixes for the configs before Christmas.

Regards,

Gerard

2

Please notice that DD0060 is also thrown with Descriptions of ItemDefs defined by Value Level Metadata (VLM).

Example: DAORRES has the description “Assessment Result in Original Units”.
I define Value Level Metadata for DAORRES based on DATESTCD=“DISPAMT” and DATESTCD=“RETAMT”. I use Descriptions for the ItemDefs in this ValueList: “Dispensed Amount” resp. “Returned Amount”.

I get DD0060 for these 2 Items, since the validator expects these 2 Items to have the same Description as the original DAORRES variable: “Assessment Result in Original Units”.

I’m not aware of a Define-XML v2 requirement for labels of Items as defined by VLM.

Can you please clarify this OpenCDISC requirement?

Thanks,
Lex Jansen

3

Hi,

When validating a define.xml (SDTMIG 3.1.3), I get these messages:

DEFINE Variable,DefineLabel,StandardLabel it.IE.IETESTCD,Inclusion/Exclusion Criterion Short Name,Incl/Excl Criterion Short Name DD0060 Define.xml/CDISC variable Label mismatch. Cross-Reference Error
DEFINE Variable,DefineLabel,StandardLabel it.SE.TAETORD,Planned Order of Element within Arm,Order of Element within Arm DD0060 Define.xml/CDISC variable Label mismatch. Cross-Reference Error

After double-checking, the provided labels are correct: the configuration file should be updated.

Cheers,
– Thierry