Issues related to Define.xml are only reported when checked without xpt data, but combination of xpt data + Define.xml does not report Define.xml issues

Define.xml validation

This is normal and necessary.
When you choose "Define.xml" under "Standard", the tool validates the define.xml on its own, i.e. whether it is a valid define.xml file, or otherwise said, it solely validates the metadata of the submission.
When you choose "SDTM" or "ADaM" or "SEND", and you provide a define.xml in the box "Define.xml", then the software will validate the datasets, and for some of the rules, will look into the define.xml e.g. for consistency.

My approach is always to validate the metadata (i.e. define.xml) first. If it has true issues, I don't even start validating the xpt files as long as I don't have the issues resolved. Only when my define.xml is in good shape, I take the next step, and start validating the xpt files, AND always provide the define.xml file, so that the validator can look into it.

It is always a good idea to separate metadata validation from data validation (e.g. to avoid confusion). Also take into account that a good define.xml is important. After all, the define.xml is "the sponsor's truth" in explaining the submission.

you need to run two separate validations for define.xml files

Hi Ashwin,

As Jozef’s already said, In P21 Community you need to run two separate validations for define.xml files.

• By selecting Standard=Define-XML, you validate define.xml file itself and receive DDxxxx and ODxxxx messages
• Combining datasets with define.xml and selecting Standard=SDTM/SEND/ADaM, you validate a consistency between your study data and metadata provided in define.xml file. There are few checks for this: SD0037, 54, 58 -  61, 1063 in P21C and additional Value-Level checks SD1128- 1231 in P21E.

Regards,

Sergiy