Contents

List of Tables

Title and Copyright Information

Preface

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

1 Introduction

• General Installation and Software Requirements
• Pre-Requisite Installation Order
  • Software Requirements for Argus Safety
• 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
  • Hardware Requirements for Argus Safety
• General Pre-Installation Tasks
• Installation Process Overview
• Converting Argus Safety Report Server to Argus Web Server

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 Database Settings
    • Argus Safety Database Instance Parameters
    • Additional Database Setup Information
  • GMT Offset Calculation
• Prerequisites for New Schema Creation
  • Creating the Argus Safety Read Only Database Account (Optional)
  • Creating the Argus Safety Database Schema
    • XDB Schema Installation Requirement for Interchange
    • Installing the Schema Creation Tool
    • Creating the Tablespaces
    • Creating the Schema
• Creating the Argus Safety Read Only Database Account (Optional)
• 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
• Enabling DLP on a Specific Enterprise
• Upgrading the Argus Safety Database
  • Prerequisites for Database Upgrade
  • Clean-up Scripts to be Run Before Upgrading the Database
    • Data Clean-up on Duplicate Event Details Information on a Single-tenant Database
    • Data Clean-up on Duplicate Event Details Information on a Multi-tenant Database
  • Database Upgrade Procedure (with or without DLP) from AS 7.0.3.1 to AS 8.0
• Post-Upgrade Steps
• Enabling Local Locking in Argus Safety
• 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
• Configuring the IIS Manager for Windows 2008 and Windows 2012
• Connecting to a Domain Account on Windows 2008 and Windows 2012
• Enabling SSL Support for Windows 2008 and 2012
• Configuring Load Balancer in Argus Web
  • Set up Argus Web Load Balancer IP Address
  • Set up Load Balanced Folders
  • Set up Shared Network Directory
• Securing Sensitive Configuration and Operational Data
• Configuring Identity in the IIS Application Pools
• Resetting IIS

5 Setting up Client Browser

• Adding the Argus Site as a Trusted Site
• Setting up Compatibility View with Internet Explorer

6 Installing Argus Safety Service

• Starting Argus Safety Service
• Setting up RightFax

7 Installing and Configuring EDI Gateway

• Creating an Axway Synchrony Database Instance
• Installing Axway Synchrony Interchange
• Starting the Axway Synchrony Server
• Configuring Axway Synchrony Interchange for Axway 5.10
  • 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
  • Adding a Node
  • Configuring Axway Synchrony Certificates
    • Configuring Receiver Axway Synchrony Certificates
    • Configuring Sender Axway Synchrony Certificates
  • Configuring EVENTS.XML
• Configuring Axway Synchrony Interchange for Axway 5.12
  • 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
  • Adding a Node
  • Configuring Axway Synchrony Certificates
    • Configuring Receiver Axway Synchrony Certificates
    • Configuring Sender Axway Synchrony Certificates
  • Configuring EVENTS.XML
• Testing Communication

8 Configuring Oracle B2B

• Integrating Oracle B2B with Argus Safety
  • Creation of integration tables in B2B Schema
  • Oracle B2B UI Configuration
    • General Configuration > Administration > Configuration
    • Document Configuration > Administration > Document
  • Enterprise Manager Configuration
    • SOA Composite Deployment
    • SOA Composite Configuration
  • Web Logic Console Configuration
    • Data source with JNDI Name as 'eis/DB/ArgusSafety_Outbound'
    • Data source as 'jdbc/ArgusSafety_Inbound'
    • Data source with JNDI Name as 'eis/DB/ArgusSafety_Inbound'
  • Large Payload Exchange Configuration
    • Outbound Files
    • Inbound Files
    • Transaction Time
    • General B2B Settings for Large Payloads
  • Configuration on Argus Safety side
    • Configure Oracle B2B
    • Update for B2B Documents
    • Argus Console > Reporting Destination Code List

9 Installing and Configuring Interchange

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

10 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 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, 2010, and 2013

11 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

12 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

13 Enabling and Configuring BIP Periodic Reports

• Preparing BI Publisher Server
• TNS Names Configuration
• Database Configuration
• Setting up the BI Publisher for Argus Safety
  • Enabling a Local Superuser
  • Configuring the Security Model
  • Configuring Server Settings
  • Creating Users and Assigning Roles
  • Creating ASBIP JDBC Connection
  • Configuring12c Database Driver for BI Publisher 11g
• Uploading the Argus Safety.xdrz file to BIP
• Integrating Argus Safety with BIP
• Argus Console-level Configurations
• Configuring Code Lists
• Creating the Database Jobs

14 Installing End of Study Unblinding

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

15 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 and Windows Server 2012
  • Protecting Files in the Argus Directory
• Configuring SSO in Oracle Access Manager 11g
  • Installing WebGate
  • Configuring WebGate on Windows Server 2008 and Windows Server 2012
  • 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

16 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

17 Argus Password Management - Cryptography Tool

• Cryptography Tool Overview
• Installing or Upgrading to Argus Safety 8.0
  • The Argus Safety 8.0 Database
  • The Argus Safety 8.0 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

18 Argus Centralized Coding

• setup_centralized_coding_interface_schema.bat
• setup_dsnav_centralized_coding.bat
• dms_migration.bat
  • Single Enterprise Migration in One Execution
  • All Enterprise Migration in One Execution

A Third Party Attributions

• Aspose
• Dundas
• Telerik
• /n software IPWorks
• Adobe Acrobat
• EMC Documentum
• ICH
• MedDRA MSSO
• Microsoft Office
• OpenText RightFax
• WHO Drug Dictionary
• Microsoft Anti-XSS and Enterprise Library
• Apache Log4net
• Prototype JavaScript Framework
• PDFlib GmbH