define.xml is not validated when validate the .xpt datasets and define.xml in P21C Version: 3.1.0

Pinnacle 21 Support Define.xml
1

Hi Junying,

Please look at your ‘Overview’ tab if a reference to define.xml file is included.

In P21 Community you need to run 2 separate validations for define.xml file.

First, validate define.xml using Define-XML standard. The tool will check you define.xml file for compliance with CDISC Define-XML standard and some additional things like FDA/PMDA requirements, correct representation of CDISC CT, etc.

Then, when validating study datasets you need to add define.xml file to check consistency of your specified metadata vs. datasets.

I assume that you 1. skipped the first step and 2. do not have any define.xml/datasets issues.

Kind Regards,
Sergiy

2

Dear P21C,

I used the latest P21C Version: 3.1.0 to validate the ADAM .xpt datasets with the define.xml. And it looks like only the .xpt datasets are validated and the define.xml is not validated(pic1). And the validaiton report ‘Dataset summary’ tab also does not list the define.xml there. Is this an issue with the P21C? Thank you very much.