Skip Headers
Oracle® Argus Safety Installation Guide
Release 8.0.1
E68657-01
Next
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