MedDRA Code Required Instead Of Event Term/Testname In E2B Reports

(Doc ID 1933244.1)

Last updated on MAY 16, 2018

Applies to:

Oracle Argus Interchange - Version 6.0.5 and later
Information in this document applies to any platform.

Goal

In Argus 6.0.5, E2Bs are generated as per the EMA default message profile with:
- B.2.i.2.b containing the Event Preferred Term (PT)
- B.3.1c containing the LLT term of the test name

Health Canada (HC) requested that E2B fields B.2.i.2.b and B.3.1c contain the MedDRA code.

This is a requlatory requirement which we are currently not able to meet.
 

Solution

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