MedDRA Code Required Instead Of Event Term/Testname In E2B Reports
(Doc ID 1933244.1)
Last updated on MAY 11, 2021
Applies to:Oracle Argus Interchange - Version 6.0.5 and later
Information in this document applies to any platform.
In Argus 6.0.5, E2Bs are generated as per the EMA default message profile with:
- [REACTIONMEDDRAPT] B.2.i.2.b containing the Event Preferred Term (PT)
- [TESTNAME] 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.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document