Does Pinnalce 21 check Domain labels when only SDTM xpt files are provided?

Pinnacle 21 Support SDTM
1

Hi Sai Krishna,

Now P21 Validator checks dataset description in a define.xml, rather than dataset labels in XPT files.

We use a table 3.1.2 (Dataset Definition Metadata) in SDTM and SEND IG documents as a source of standard dataset labels.

Kind Regards,

Sergiy

2

Hi Team,

Can you please guide me through how Pinnacle 21 checks dataset label compliance? Does it check against SDTM IG “description” when only dataset xpt files are provided as input or is it irrespective of SDTM IG and just have to follow the conformance rules provided by FDA and should be meaningful?

Thanks,

Sai Krishna.