MedDRA Code Required Instead Of Event Term/Testname In E2B Reports
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.
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.
Sign In with your My Oracle Support account
Don't have a My Oracle Support account? Click to get started
My Oracle Support provides customers with access to over a
Million Knowledge Articles and hundreds of Community platforms