What is Null Flavor data?

Null Flavors are used to describe the reason for missing data. ICH E2B(R3) and regional agencies such as CBER, EMA, MFDS, and PMDA have published guidelines on the allowed Null Flavors for various fields that are part of the E2B(R3) report. A Null Flavor set is a collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors in the Flexible Re-categorization Codelist.

Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor button () 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. The data is cleared or retained based on user confirmation. When data pertaining to the field is received, Null Flavor data can be overwritten by actual data by clicking the NF button.