Updates to EMA E2B(R2) submissions when patient related fields are marked for Protect Confidentiality

EMA GVP Module VI revision 2 recommends that data elements such as patient's age, age group and gender are submitted in non-redacted form. In order to handle this, the export mapping logic for the below elements of the ICH-ICSR V2.1 MESSAGE TEMPLATE – EMA profile is updated to send the available data even if Protect Confidentiality is checked in the Case form > Patient Information section:

1. PATIENTONSETAGE [B.1.2.2a]
2. PATIENTONSETAGEUNIT [B.1.2.2b]
3. PATIENTAGEGROUP [B.1.2.3]
4. PATIENTSEX [B.1.5]

For more information on mappings, refer to the ArgusInterchange823_E2B(R2) 2.1 Export Mappings.xlsx mapping document.