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Does Pinnalce 21 check Domain labels when only SDTM xpt files are provided?
s
Sergiy
on June 5, 2017
Now P21 Validator checks dataset description in define.xml file
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
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.