n Nari
on

 

What are different about the pinnacle 21 validation results for the define.xml, between on the validation to the define.xml together with xpt datasets and to only the define file?

Forums: Define.xml

Sergiy
on October 30, 2020

Hi Nari, 

In Pinnacle 21 Community, validation of Define.xml file is 2-step process. First, you need to validate Define.xml file for compliance with CDISC standards and internal data consistency using Standard="Define-XML" option. The second step is to ensure that study-specific metadata in Define.xml file is consistent with your study datasets. It covers during validation of your study data (Standard="SDTM", "ADaM", "SEND", etc.). In addition to study datasets, you need to include Define.xml file when starting validation process.

Kind REgards,
Sergiy  

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