a Abhijeet
on

 

A variable on a CRF with a CodeList has 3 possible terms (e.g. Mild, Moderate, Severe) but only 2 terms (e.g. Mild, Severe) occur in the dataset by the end of the trial.

In the define xml should the CodeList associated with this variable have all 3 defined terms on the CRF or only 2 terms that occur in the dataset ? Thanks.

 

Forums: Define.xml

j Jozef
on April 21, 2017

A question very often asked...
The define.xml contains the metadata of "all that could have been possible".
So you definitely need to have all three items (one for each checkbox on the CRF) in your define.xml, even if one of them was never checked.
We have seen many violations to this, caused by the "post-SDTM" generation of define.xml, which I consider bad practice.
 

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.