Contents

List of Tables

Title and Copyright Information

Preface

• Intended Audience
• Documentation Accessibility
• About This Book
• Related Documents
• Revision History
• Checking My Oracle Support
• Conventions

1 Introduction

• General Installation and Software Requirements
• Pre-Requisite Installation Order
  • Argus Safety Database Server Installation Requirements
  • Argus Safety Web Server Installation Requirements
  • Argus Safety Report Server Installation Requirements
  • Argus Transaction Server Installation Requirements
  • Argus Interchange Server Requirements
  • Argus Safety Web Client Installation Requirements
  • Argus End of Study Unblinding Tool (EOSU) Installation Requirements
• Argus Safety Hardware Topology
  • Recommended Hardware Topology for a Small Company
  • Recommended Hardware Topology for a Mid-sized Company
  • Recommended Hardware Topology for a Large Company
• General Pre-Installation Tasks
• Installation Process Overview

2 Starting the Installation

• Getting Started
• Installing the Files Required to View Japanese Text

3 Installing the Argus Safety Database

• Overview
• Schemas Required for Database Instances
  • Argus Safety Instance Database Schemas
  • Axway Synchrony Database Instance (Optional)
• Setting up Oracle Parameters
  • Oracle 11g Database Settings
    • Argus Safety Database Instance Parameters
    • Additional Database Setup Information
  • GMT Offset Calculation
• Prerequisites for New Schema Creation
  • Creating the Argus Safety Database Schema
    • XDB Schema Installation Requirement for Interchange
    • Installing the Schema Creation Tool
    • Creating the Tablespaces
    • Creating the Schema
• Loading Factory Data
• Enabling and Disabling Oracle Text
  • Enabling Oracle Text
  • Disabling Oracle Text
• Implementing Table Partitioning
• Working with the MedDRA and MedDRA J Dictionaries
  • Loading the MedDRA Dictionary
    • Overwriting an Existing MedDRA Dictionary
    • Recoding Events
  • Loading the J Drug Dictionary
  • Overwriting an Existing J Drug Dictionary
• Loading the WHO-DRUG Dictionary
  • Loading the WHO-Drug Dictionary to New Tables
  • Loading the WHO-Drug Dictionary Using the Overwrite Option
  • To Load the WHO-Drug Dictionary using the Format C Option
• Validating the Argus Safety Database
• Enabling and Disabling DLP
  • Creating the Tablespaces
  • Enabling DLP
  • Disabling DLP
• Upgrading the Argus Safety Database
  • Database Upgrade Procedure (with or without DLP) from AS 7.0.2 to AS 7.0.3
• Merging a Single Enterprise Safety Database into a Multi-tenant Database
  • Prerequisites to Running the Merge Export Step
  • Prerequisites to Running the Merge Import Step
  • Completing the Merge Process
    • Merge Export
    • Exporting the dmp File Copy to the Target Database Server
    • Merge Import
    • Manual Dictionary Synchronization
• Copy Configuration Tool

4 Installing Argus Safety Web

• Installing Argus Safety Web
• Adding the Argus Site as a Trusted Site
• Configuring the IIS Manager for Windows 2008
• Connecting to a Domain Account on Windows 2008
• Enabling SSL Support for Windows 2008
• Configuring Load Balancer in Argus Web
  • Set up Argus Web Load Balancer IP Address
  • Set up Load Balanced Folders
  • Set up Shared Network Directory
• Installing Argus Report Server
  • Recommended Changes in IIS 7.5 on the Report Server
• Securing Sensitive Configuration and Operational Data
• Configuring Identity in the IIS Application Pools
• Resetting IIS

5 Installing Argus Safety Service

• Starting Argus Safety Service
• Setting up RightFax

6 Installing and Configuring EDI Gateway

• Creating an Axway Synchrony Database Instance
• Installing Axway Synchrony Interchange
• Starting the Axway Synchrony Server
• Configuring Axway Synchrony Interchange
• Configuring Axway Synchrony for Binary File Transmission
• Configuring Axway Synchrony Community
  • Registering with the Axway Synchrony Community
  • Adding a Partner to the Axway Synchrony Community
    • Registering the Receiver's Community on the Sender Server
• Adding a Node
• Configuring Axway Synchrony Certificates
  • Configuring Receiver Axway Synchrony Certificates
  • Configuring Sender Axway Synchrony Certificates
• Configuring EVENTS.XML
• Testing Communication

7 Installing and Configuring Interchange

• Installing Interchange Service
• Configuring Interchange Service
  • Transmitting E2B Attachments
• Accessing EDI Gateway Shared Folders
• Configuring the Interchange Service.INI File

8 Performing Post-installation Checks

• Post-Installation Tasks
  • General Checklist
  • Configuring Argus Safety Windows Service to run as a Domain User
  • Configure Worklist Intake
    • RelsysWindowsService.exe.config
    • Service.config
    • Intake.config
  • IIS Checklist
  • .INI File Checklist
  • Service Checklist
• Verifying the Web Server Installation and IIS Configurations
  • Verifying IIS 7 Configuration
• Configure and Verify the Dossier Installation
  • Configuring the Dossier Application
  • Verifying the Dossier Installation
• Verify Files installed on Middle Tier Servers:
• Verifying the Documentum Installation
• Validating the easyPDF Installation
  • Validating the easyPDF Installation for Word 2007 and Word 2010

9 Enabling IIS HTTP Compression

• IIS Web Page Compression
  • HTTP Compression
  • Known Effects of Enabling Compression
  • How to Enable HTTP Compression
• IIS Caching Settings
  • IIS Caching
  • Known Effects of Enabling Caching
  • How to Enable Caching
• Local Internet Explorer (IE) Client Caching Settings
  • IE Client Caching
  • IE Client Caching Tab Options
  • How to Enable IE Caching

10 Configuring E-mail

• About E-mail Configuration
• Configuring SMTP
  • Using the SMTP Configuration Utility
  • Functions Affected by SMTP
    • Bulk Report Transmit E-mail
    • Autosignal E-mail
    • Fax E-mail
    • Fax Status E-mail
    • Priority E-mail
    • Dossier Notification E-mail
    • E-mail Sent by Interchange Service

11 Installing End of Study Unblinding

• EOSU Hardware/Software Requirements
• How to Install the EOSU Utility

12 Other Tasks

• Configuring the Argus.xml File
• Configuring the Argus.ini File
  • Increasing the Internet Explorer Timeout Setting to Run Reports
• Deploying a Portlet on Oracle WebLogic Server
• Deploying the Global Home Application on a WebLogic Server
  • Configure Global Homepage Properties File
    • Update Global Homepage Properties File
    • Deploy Company Logo
  • Pre-Deployment Configuration
• Configuring SSO in Oracle Access Manager 10g
  • Installing WebGate
  • Configuring WebGate on Windows Server 2008
  • Protecting Files in the Argus Directory
• Configuring SSO in Oracle Access Manager 11g
  • Installing WebGate
  • Configuring WebGate on Windows Server 2008
  • Protecting Files in the Argus Directory
• Installation and Configuration of Oracle Web Tier Suite
  • Installing Oracle Web Tier
  • Configuring Oracle Web Tier
  • Oracle Http Server Administration
  • Configuring Oracle Http Server as Reverse Proxy Server for WebLogic
• Configuring the WebCenter Security Provider for Identity Assertion
  • Configuring the Oracle Internet Directory Authenticator
  • Configuring the OAM Identity Asserter
  • Configuring the Default Authenticator and Setting the Order of Providers
  • Setting EXTRA_JAVA_PROPERTIES for WebLogic Domain
• Installation Maintenance Tasks
  • Installing New Components
  • Uninstalling Components
  • Removing All Components
• Web Client Tips
• Clearing Oracle Temp Files
• Configuring easyPDF
  • Setting Up easyPDF
  • Setting up Microsoft Office
  • Using Display PDF in Browser
• Setting Printer Defaults
• Argus Configuration Files

13 Argus Integrations

• Installing Argus Integrations
• Resetting IIS
• Overview: Argus Web Service Interface
  • Argus Web Service Interface Framework
• Basic Configuration Overview
  • Outbound Interface
  • Inbound Interface
• Safety Message Overview
• MedDRA Interface
  • Overview
  • MedDRA Encoding Safety Message Example
    • Request (V 1.1)
    • Response (V 1.1)
    • Request (V 1.0)
    • Response (V 1.0)
  • MedDRA Dictionary: XML Schema
    • Request: MEDDRA_Request
    • Request: MEDDRA_Response
  • Flow of MedDRA Auto Encoding
  • Configuration
• Product License Study Interface
• WHO Drug Coding Interface
  • Overview
  • WHO Drug Coding Safety Message Example
    • Request
    • Response
  • WHO Drug Coding: XML Schema
    • Request: WHODrug_Request
    • Response: WHODrug_Response
  • Flow of Drug Dictionary Coding
  • Configuration
• Lot Number Interface
  • Overview
  • Lot Number Safety Message Example
    • Request
    • Response
  • Lot Number: XML Schema
    • Request: Lot_Request
    • Response: Lot_Response
  • Flow of Lot Validation
  • Configuration
  • Transformation
• Worklist Intake
  • Flow of Worklist Intake
  • Worklist Intake Safety Message Example
  • Configuration
• Literature Intake
  • Flow of Literature Intake
  • Configuration
    • Metadata Configuration
• Extended E2B Interface
  • E2B Mapping Updates
  • Adding Extension Elements to DTD
  • Prepare Factory Data for Extension Elements
  • Create Business Logic for Extension Elements
  • Configure Reporting Destination for Extension Profile
  • Extension Elements Sample XML
  • Extension Elements Sample Import PL/SQL Block

14 Argus Password Management - Cryptography Tool

• Cryptography Tool Overview
• Installing or Upgrading to Argus Safety 7.0.3
  • The Argus Safety 7.0.3 Database
  • The Argus Safety 7.0.3 Application Servers
  • Generating a New Cryptography Key
• Resetting Password / Changing the Cryptography Key
  • Resetting the ARGUSUSER Password
  • Editing Keys
  • Re-encrypting Common User Passwords
  • Generating Encrypted String from Clear Text on Configured User Cryptography Key
  • Resetting the Environment if ArgusSecureKey.ini is Lost

A Third Party Attributions