Value Of D.2.2a [PATIENTONSETAGE] Or D.2.3 [PATIENTAGEGROUP] Should Exist If PATIENTBIRTHDATER3 Is MSK (Doc ID 3066100.1)

Last updated on JANUARY 06, 2025

Applies to:

Goal

Receive the below error when trying to generate E2B R3 using the shipped standard EMA profile:

This is happening when the full date of birth is entered, Initials are masked using Null Flavour or Unknown (NF-UNK), no value in age and age units as well as age group.

This is happening for a destination European Medicines Agency (EMA) which uses Out of the Box (OOTB) E2B EMA R3 profile and has the protect confidentiality checkbox in the reporting rule for that destination (EMA) enabled.

How to manage this error if there is a valid date of birth available to enter?

Users cannot use NF-MSK in Date of Birth (DOB), as the Individual Case Safety Report (ICSR) would be reportable to other destinations where this validation is not applicable.
 

Solution

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