Argus Standard Edition Implementation Fundamentals (D87788) – Details

Detaillierter Kursinhalt

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
• eVAERS

Advanced Conditions

• Create Advanced Condition
• Create Advanced Condition Query Sets
• Case Series
• Advanced Condition Library

Argus Safety System Configuration

• Common Profile Switches
• Access Management
• Workflow
• Codelist
• 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
• Architecture
• BIP Aggregate Reporting
• BIP Aggregate DSUR