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Oracle® Argus Safety Installation Guide
Release 7.0.5
E58285-05
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Contents
List of Tables
Title and Copyright Information
Preface
Intended Audience
Documentation Accessibility
About This Book
Related Documents
Checking My Oracle Support
Finding Oracle Documentation
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
Enabling DLP on a Specific Enterprise
Upgrading the Argus Safety Database
Database Upgrade Procedure (with or without DLP) from AS 7.0.4.1 or AS 7.0.3.004 to AS 7.0.5
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
Setting Compatibility View with Internet Explorer
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 7.0.5
The Argus Safety 7.0.5 Database
The Argus Safety 7.0.5 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