y Ying
on

 

How to set the type of variable RDOMAIN in SUPP-- dataset based on define V2.1? Based on the example of define V2.1.5, the type of this variable RDOMAIN is "Derived". However, RDOMAIN is not calculated from ANY variable with the formula. Is it more likely to "Assigned"? So, is there a clear definition of the type for variable RDOMAIN?

Example of define V2.1.5:define V2.1

Forums: Define.xml

j Jozef
on September 12, 2023

It depends on how you create the SUPP-- dataset.
For example, in our own GUI-based SDTM-ETL mapping software, for non-standard-variables (NSVs) that (unfortunately) need to go in a SUPP-- dataset (we call it "banned" to SUPP--), the variable is just treated as a normal variable (i.e. in the normal domain), and "split-off" at the end of the process when the user selects that option, which is usually the case for FDA submissions. In that case there surely is an algorithm, so that one can set RDOMAIN to "derived" (algorithm = picking up the DOMAIN from the original dataset definition) but then indeed one also needs to supply a corresponding "MethodDef" in the define.xml, describing that algorithm.
In case one however "hard-codes" RDOMAIN on an individual case, e.g. having $RDOMAIN="LB" in the mapping script, then it surely is "assigned".
Also remark that the difference between "Derived" and "Assigned" can be pretty small.

What software do you use? In modern, GUI-based software, setting the "Origin" and "Source" can be easily done, usually by GUI "wizards".

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