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Argus Standard Edition Implementation Fundamentals

This Argus Standard Edition Implementation Fundamentals training teaches you how to implement and configure the products included in Argus Standard Edition (Argus Safety, Argus Interchange, Argus Affiliate, Argus Un-blinding), Argus Japan, as well as other new features introduced in Argus 8 in addition to Oracle B2B and BIP.

Required Prerequisites:

  • Experience with pharmacovigilance concepts and terminologies.
  • Ideally have one to three years of experience with Oracle Argus Safety
  • Ideally have participated in at least one Oracle Argus Safety implementation
Course Content:

Argus Standard Edition Overview

Argus Safety and Available Modules
Application Architecture
Live Installation
Integration Overview
Upgrade Methodology
Migration Methodology
Argus Safety Business Configuration

Products and License Configuration
Studies Configuration
Argus Safety Case Processing

Data Entry
Safety Review
Medical Review
Quality Review
Argus Safety Expedited Reporting to Regulatory Authorities

Schedule, Generate and Transmit Expedited Reports
Track Expedited Reports
Accept Incoming E2B Reports
Argus Safety Business Configuration Continued

Expedited Reporting Rules
ESM and AG Service Configuration
E2B R3
Medwatch Updates
Advanced Conditions

Create Advanced Condition
Create Advanced Condition Query Sets
Case Series
Advanced Condition Library
Argus Safety System Configuration

Common Profile Switches
Access Management
Field Labels and User Defined Fields
Field Validations
System Numbering
Case Priority
E2B Extension Profile

Configure ESM Mapping
Configure Database tables
Argus Console Configuration
Schedule E2B extended report
Argus Local Affiliate Configuration

Create LAM Site
Create and Configure LAM Users
Access Argus Affiliate Module
Create, Process and Route Cases to Argus Safety
Accept and Process LAM cases in Argus Safety
Perform Local Labeling in Argus Affiliate
Perform Local Reports in Argus Affiliate
Argus Unblinding

Argus Console Configuration
Argus Unblinding module Configuration
Argus Safety Japan Configuration

Enable Argus Japan Module
Create and Configure Japan Group and User
Access Argus Japan Module
Review Cases in Argus Japan Module
Local Case Data Lock

Argus Console Changes
Case Form Icon Changes
Local Prospective Reportable Case
Truly Local Case Configuration
Configure Global and Local User Privileges
Perform Global and Local Lock with different scenarios
Argus Safety Multi-tenant

Enterprise Setup
Enterprise Configuration
Oracle B2B Gateway

Creation of Integration Tables in B2B Schema
B2B UI configuration
Argus Safety Configuration
Transmission and Tracking
Oracle BIP Integration

BI Publisher Overview
BIP Aggregate Reporting
BIP Aggregate DSUR
Natural    Natural   Natural   Natural   Natural   Natural   Natural   Natural   Natural   Natural   Natural