MedDRA Code Required Instead Of Event Term/Testname In E2B Reports (Doc ID 1933244.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences 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:
- [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.

Solution

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In this Document

Goal

Solution

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MedDRA Code Required Instead Of Event Term/Testname In E2B Reports (Doc ID 1933244.1)

Applies to:

Goal

Solution

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!