Mapping changes for E2B(R3) reports for Null Flavor data

Summary

Enhancement to E2B(R3) reports when Protect Confidentiality is enabled and case data has null flavor (Enhancement 38051289)

Description

The Argus E2B(R3) generation logic is enhanced to correctly handle Null Flavor values when the Protect Confidentiality flag is enabled. Previously, allowed Null Flavor values (e.g., UNK, ASKU) were replaced with MSK during transmission. With this enhancement, Null Flavor values entered in the case are retained as-is, and MSK is applied only when actual patient/reporter data is present and confidentiality must be protected. This change ensures compliance with ICH E2B(R3) guidelines and EMA GVP masking rules.

Impacted profiles include:

• EMA E2B(R3) – ICH-ICSR V3.0 MESSAGE TEMPLATE – EMA
• FDA E2B(R3) – ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS