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Changes in J2.4.k validation as per PMDA E2B R3 Checkrules_v3.1.6 - Steps to perform in Argus (Doc ID 2796744.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1 and later
Oracle Life Sciences Argus Interchange - Version 8.1 and later
Oracle Life Sciences Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Purpose

This KM article contains the steps to implement the changes identified in J2.4.k validation as per PMDA E2B R3 Checkrules_v3.1.6.

Scope

 

Details

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In this Document
Purpose
Scope
Details
 Introduction
 PMDA E2B R3 guidance update on 31-Aug-2020 for Investigational reporting
 Changes in J2.4.k validation as per PMDA E2B R3 Checkrules_v3.1.6 - Steps to perform in Argus
References

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