Oracle Argus Safety 7 Implementation Essentials 

Содержание

Exam Topics:

Solution/Product Overview

• Describe the differences between Argus used at a device, biopharma or Contract Research Organization (CRO)/Academic Research Organization (ARO)
• Describe the Argus modules and their basic use
• Identify and organize the general project management needs to perform an implementation of Argus
• Describe the global regulatory frameworks that govern a validated system implementation

Application Architecture

• Create the suggested application architecture for a single tenant install at a small, medium or large company
• Create the required application architecture for a multi-tenant install including major differences between single and multi-tenant installations
• Describe the various license requirements for the Argus software and all of its modules

Installation

• Describe the steps in the Argus single-tenant installation process
• Describe the differences between an Argus and Argus Japan installation process
• Identify and resolve problems in the installation process of both Argus single-tenant and Argus multi-tenant
• Describe the installation process for the additional modules of Argus (End Of Study Unblinding Tool (EOSU), Interchange, Dossier etc.)
• Integrate Argus with different external systems of interest
• Apply upgrade methodology when moving from one version of Argus to another
• Apply data migration techniques to the migration of data from a non-Argus source into Argus

Configuration Activities

• Describe the general division of configuration activities within Argus
• Complete the configuration of Products in Argus
• Complete the configuration of Studies in Argus
• Complete the configuration of Regulatory Report Rules in Argus
• Complete the configuration of Site/Groups/Users in Argus
• Complete the configuration of Workflow in Argus
• Complete the configuration of Field Validations in Argus
• Complete the configuration of Field Labels and User Defined Fields in Argus
• Complete the configuration of System Numbering in Argus and Affiliate
• Complete the configuration of Case Priority in Argus
• Complete the configuration of AG-Services in Argus
• Complete the configuration of Argus Interchange
• Complete the required Dossier configuration
• Complete the required End Of Study Unblinding Tool (EOSU) configuration
• Complete the required Argus-J configuration
• Complete the required Multi-tenancy configuration (Global Homepage maintenance)