NullFlavors

NullFlavors are used to describe the reason for missing data. ICH E2B (R3) and regional agencies
such as CBER, EMA, and PMDA have published guidelines on the allowed Null Flavors for
various fields that are part of the E2B (R3) report.

How is it handled in Argus Safety System?
Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor button
(nf) next to the fields. On clicking the button, a drop-down list appears and allows you to select
Null Flavor data as configured in the Field Properties Configuration in the Argus Console. The
background color of the NF button changes (from grey to blue) when a Null Flavor is selected
from the drop-down list.

When the Case Form field has data and the user clicks the button, the system displays a warning
message that data will be cleared on switching to the Null Flavor field.