Inconsistent value of QNAM within Qlabel

Sergiy

on November 22, 2019

P21

This is FDA business rule (FDAB009)

Hi Meenal, 

This is FDA business rule (FDAB009): 

All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. 

'All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM).

Some users (e.g., FDA Medical Reviewers) prefer to work using variable Labels instead of Names. The same Labels for different variables are confusing.

Common implementation is to use Labels like "Reported Term for the Medical History 1", "Reported Term for the Medical History 2", etc.

Kind Regards, 

Sergiy

paired variables

Without trying to give a judgement, this is interesting ...

I always believed the first thing reviewers do in their systems when importing the XPT datasets is to:
- recombine character strings >200 characters from "parent" dataset and "SUPPQUAL" dataset into a single string (using the label of the parent variable)
- after this, move all remaining "SUPPQUAL" variables by QNAM back to the parent dataset, i.e. each QNAM value becomes a column in the original dataset.

This is functionality that simple (review) tools like the "Smart Submission Dataset Viewer" master. Also SAS- or R-based software can easily do this.

Also, what would be the procedure if the original label is already 39 or 40 characters long? Adding a blank plus a sequence number would then violate the 40 character limitation.

Clarification on the FDA business rule -FDAB009

Hi Siergy,

I was wondering whether this rule FDAB009 checks across the  domains  or within the domain .

Please clarify.

Thanks in Advance.

Sri

Sergiy

on November 25, 2019

P21

Hi Sri,  Now this rule…

Hi Sri, 

Now this rule works only within each domain.

Kind Regards, 

Sergiy

Thanks for your response…

Thanks for your response Sergiy.