SE0063: SEND/dataset variable label mismatch

Is your new variable SEND/ SDS variable?

Is your new variable SEND/ SDS variable? Or it's SEND+ data?

Re: Is your new variable SEND/ SDS variable?

It is a new variable named CLREFID (it's not specified by SEND or SDS) and we need it for grouping (other domains have the --REFID field, but not CL).

Should this variable be written in suppcl.xpt instead of cl.xpt?

From my understanding, an .xpt with an additional variable like this is "acceptable" by FDA.

FDA will use standard specs

I am not sure about FDA, but my personal opinion is that it’s a bad practice to include non-standard variables in submission data. You are losing compliance with target standards. And the major purpose of the OpenCDISC validator is to check compliance of your data with standards. Technically you can do some simple modifications of the tool specifications files to avoid error messages about non-standard variables. However, FDA will use original specs, rather than your customized specs. The issue will still occur during submission validation, and you will need to explain/ justify them. Therefore there are two basic options for you: 1. Move info into SUPPQUAL (no validation warning, but less convenient for review) 2. Keep it as additional to standard SEND variables (could be more convenient for review, but standard compliance issue) I would recommend discussing this issue with the FDA team during your initial submission planning meeting with them. Be preparing to the fact that FDA reviewers dedicated to your submission could not be ready to answer to this question. On the other side, it’s completely reasonable to extend current standards to fit your company internal process. If you like to use CLREFID as the company standard variable, you can modify OpenCDISC specs according your company standards. For internal use only.

Re: FDA will use standard specs

Thank you for the detailed answer, Sergiy.

By "you can modify OpenCDISC specs according your company standards" you mean changes in config-send-${SEND_VERSION}.xml?

Like removing a ValidationRuleRef for a specific domain (if I'm not interested in having that specific validation performed), or adding/updating some rules in the ValidationRules section (if I'm interested in performing my own additional, custom validations on the datasets).

There are three locations

There are three locations used to define standard variables: #1 and #2 are in “config/config-send-3.0.xml”, which is an extension (+ validation rules) to define.xml . See CDISC CRT DD Specifications for details. #3 is a “config/data/ SEND Metadata 3.0.csv” file. Make a search for some particular variable value (e.g., CL.TESTCCD or CLTESTCD) in those files to understand how it works.