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Oracle® Argus Safety Installation Guide
Release 8.1
E71757-01
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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
Conventions
1
Introduction
1.1
General Installation and Software Requirements
1.2
Pre-Requisite Installation Order
1.2.1
Software Requirements for Argus Safety
1.3
Argus Safety Hardware Topology
1.3.1
Recommended Hardware Topology for a Small Company
1.3.2
Recommended Hardware Topology for a Mid-sized Company
1.3.3
Recommended Hardware Topology for a Large Company
1.3.4
Hardware Requirements for Argus Safety
1.4
General Pre-Installation Tasks
1.5
Installation Process Overview
1.6
Converting Argus Safety Report Server to Argus Web Server
2
Starting the Installation
2.1
Getting Started
2.2
Installing the Files Required to View Japanese Text
3
Installing the Argus Safety Database
3.1
Overview
3.2
Schemas Required for Database Instances
3.2.1
Argus Safety Instance Database Schemas
3.2.2
Axway Synchrony Database Instance (Optional)
3.3
Setting up Oracle Parameters
3.3.1
Oracle Database Settings
3.3.1.1
Argus Safety Database Instance Parameters
3.3.1.2
Additional Database Setup Information
3.3.2
GMT Offset Calculation
3.4
Prerequisites for New Schema Creation
3.4.1
Creating the Argus Safety Read Only Database Account (Optional)
3.4.2
Creating the Argus Safety Database Schema
3.4.2.1
XDB Schema Installation Requirement for Interchange
3.4.2.2
Installing the Schema Creation Tool
3.4.2.3
Creating the Tablespaces
3.4.2.4
Creating the Schema
3.5
Creating the Argus Safety Read Only Database Account (Optional)
3.6
Loading Factory Data
3.7
Enabling and Disabling Oracle Text
3.7.1
Enabling Oracle Text
3.7.2
Disabling Oracle Text
3.8
Implementing Table Partitioning
3.9
Working with the MedDRA and MedDRA J Dictionaries
3.9.1
Loading the MedDRA Dictionary
3.9.1.1
Overwriting an Existing MedDRA Dictionary
3.9.1.2
Recoding Events
3.9.2
Loading the J Drug Dictionary
3.9.3
Overwriting an Existing J Drug Dictionary
3.10
Loading the WHO-DRUG Dictionary
3.10.1
Loading the WHO-Drug Dictionary to New Tables
3.10.2
Loading the WHO-Drug Dictionary Using the Overwrite Option
3.10.3
To Load the WHO-Drug Dictionary using the Format C Option
3.11
Validating the Argus Safety Database
3.12
Enabling and Disabling DLP
3.12.1
Creating the Tablespaces
3.12.2
Enabling DLP
3.12.3
Disabling DLP
3.13
Enabling DLP on a Specific Enterprise
3.14
Upgrading the Argus Safety Database
3.14.1
Prerequisites for Database Upgrade
3.14.2
DLP Data Correction Script to be Run Before Upgrading the Database
3.14.3
Data Migration Logic for New Fields
3.14.4
Database Upgrade Procedure (with or without DLP) from AS 8.0 to AS 8.1
3.15
Post-Upgrade Steps
3.16
Enabling Local Locking in Argus Safety
3.17
Merging a Single Enterprise Safety Database into a Multi-tenant Database
3.17.1
Prerequisites to Running the Merge Export Step
3.17.2
Prerequisites to Running the Merge Import Step
3.17.3
Completing the Merge Process
3.17.3.1
Merge Export
3.17.3.2
Exporting the dmp File Copy to the Target Database Server
3.17.3.3
Merge Import
3.17.3.4
Manual Dictionary Synchronization
3.18
Copy Configuration Tool
4
Installing Argus Safety Web
4.1
Installing Argus Safety Web
4.2
Configuring the IIS Manager for Windows 2012
4.3
Connecting to a Domain Account on Windows 2012
4.4
Enabling SSL Support for Windows 2012
4.5
Configuring Load Balancer in Argus Web
4.5.1
Set up Argus Web Load Balancer IP Address
4.5.2
Set up Load Balanced Folders
4.5.3
Set up Shared Network Directory
4.6
Securing Sensitive Configuration and Operational Data
4.7
Configuring Identity in the IIS Application Pools
4.8
Resetting IIS
5
Setting up Client Browser
5.1
Adding the Argus Site as a Local Intranet Site
5.2
Setting up Compatibility View with Internet Explorer
6
Installing Argus Safety Service
6.1
Starting Argus Safety Service
6.2
Setting up RightFax
7
Installing and Configuring EDI Gateway
7.1
Creating an Axway Synchrony Database Instance
7.2
Installing Axway Synchrony Interchange
7.3
Starting the Axway Synchrony Server
7.4
Configuring Axway Synchrony Interchange for Axway 5.10
7.4.1
Configuring Axway Synchrony Interchange
7.4.2
Configuring Axway Synchrony for Binary File Transmission
7.4.3
Configuring Axway Synchrony Community
7.4.3.1
Registering with the Axway Synchrony Community
7.4.3.2
Adding a Partner to the Axway Synchrony Community
7.4.4
Adding a Node
7.4.5
Configuring Axway Synchrony Certificates
7.4.5.1
Configuring Receiver Axway Synchrony Certificates
7.4.5.2
Configuring Sender Axway Synchrony Certificates
7.4.6
Configuring EVENTS.XML
7.5
Configuring Axway Synchrony Interchange for Axway 5.12
7.5.1
Configuring Axway Synchrony for Binary File Transmission
7.5.2
Configuring Axway Synchrony Community
7.5.2.1
Registering with the Axway Synchrony Community
7.5.2.2
Adding a Partner to the Axway Synchrony Community
7.5.3
Adding a Node
7.5.4
Configuring Axway Synchrony Certificates
7.5.4.1
Configuring Receiver Axway Synchrony Certificates
7.5.4.2
Configuring Sender Axway Synchrony Certificates
7.5.5
Configuring EVENTS.XML
7.6
Testing Communication
8
Configuring Oracle B2B
8.1
Integrating Oracle B2B with Argus Safety
8.1.1
Creation of integration tables in B2B Schema
8.1.2
Oracle B2B UI Configuration
8.1.2.1
General Configuration > Administration > Configuration
8.1.2.2
Document Configuration > Administration > Document
8.1.3
Enterprise Manager Configuration
8.1.3.1
SOA Composite Deployment
8.1.3.2
SOA Composite Configuration
8.1.4
Web Logic Console Configuration
8.1.4.1
Data source with JNDI Name as 'eis/DB/ArgusSafety_Outbound'
8.1.4.2
Data source as 'jdbc/ArgusSafety_Inbound'
8.1.4.3
Data source with JNDI Name as 'eis/DB/ArgusSafety_Inbound'
8.1.4.4
DB Adapters for Data Source
8.1.5
Large Payload Exchange Configuration
8.1.5.1
Outbound Files
8.1.5.2
Inbound Files
8.1.5.3
Transaction Time
8.1.5.4
General B2B Settings for Large Payloads
8.1.6
Configuration on Argus Safety side
8.1.6.1
Configure Oracle B2B
8.1.6.2
Update for B2B Documents
8.1.6.3
Argus Console > Reporting Destination Code List
9
Installing and Configuring Interchange
9.1
Installing Interchange Service
9.2
Configuring Interchange Service
9.2.1
Transmitting E2B Attachments
9.3
Accessing EDI Gateway Shared Folders
9.4
Configuring the Interchange Service.INI File
10
Performing Post-installation Checks
10.1
Post-Installation Tasks
10.1.1
General Checklist
10.1.2
Configuring Argus Safety Windows Service to run as a Domain User
10.1.3
Configure Worklist Intake
10.1.3.1
RelsysWindowsService.exe.config
10.1.3.2
Service.config
10.1.3.3
Intake.config
10.1.4
IIS Checklist
10.1.5
.INI File Checklist
10.1.6
Service Checklist
10.2
Verifying the Web Server Installation and IIS Configurations
10.2.1
Verifying IIS Configuration
10.3
Configure and Verify the Dossier Installation
10.3.1
Configuring the Dossier Application
10.3.2
Verifying the Dossier Installation
10.4
Verify Files installed on Middle Tier Servers:
10.5
Verifying the Documentum Installation
11
Enabling IIS HTTP Compression
11.1
IIS Web Page Compression
11.1.1
HTTP Compression
11.1.2
Known Effects of Enabling Compression
11.1.3
How to Enable HTTP Compression
11.2
IIS Caching Settings
11.2.1
IIS Caching
11.2.2
Known Effects of Enabling Caching
11.2.3
How to Enable Caching
11.3
Local Internet Explorer (IE) Client Caching Settings
11.3.1
IE Client Caching
11.3.2
IE Client Caching Tab Options
11.3.3
How to Enable IE Caching
12
Configuring E-mail
12.1
About E-mail Configuration
12.2
Configuring SMTP
12.2.1
Using the SMTP Configuration Utility
12.2.2
Functions Affected by SMTP
12.2.2.1
Bulk Report Transmit E-mail
12.2.2.2
Autosignal E-mail
12.2.2.3
Fax E-mail
12.2.2.4
Fax Status E-mail
12.2.2.5
Priority E-mail
12.2.2.6
Dossier Notification E-mail
12.2.2.7
E-mail Sent by Interchange Service
13
Enabling and Configuring BI Publisher Periodic Reports
13.1
Preparing BI Publisher Server
13.2
TNS Names Configuration
13.3
Database Configuration
13.4
Setting up the BI Publisher for Argus Safety
13.4.1
Enabling a Local Superuser for BI Publisher Standalone Install
13.4.2
Configuring the Security Model
13.4.3
Creating ASBIP JDBC Connection
13.4.4
Setting-up Runtime BI Publisher Memory
13.5
Managing Users and Roles in BI Publisher Security Model [BI Publisher Standalone]
13.5.1
Creating Users and Assigning Roles
13.5.2
Creating Custom Roles
13.6
Managing Users and Roles in Oracle Fusion Middleware [BI Publisher Standalone]
13.6.1
Creating Users and Assigning Groups
13.6.2
Creating Roles and Policies
13.6.3
Managing Privileges and Folder Rights
13.7
Managing Users and Roles for BI Publisher [OBIEE and BI Integrated Installation]
13.7.1
Creating Users and Assigning Groups
13.7.2
Creating Roles and Policies
13.7.3
Managing Privileges and Folder Rights
13.8
Uploading the Argus Safety.xdrz file to BI Publisher
13.9
Integrating Argus Safety with BI Publisher
13.10
Argus Console-level Configurations
13.11
Configuring Code Lists
13.12
Creating the Database Jobs
13.13
Upgrading Flexible Aggregate Reports from 8.0 to 8.1
13.13.1
Upgrading Argus Safety Database from 8.0 to 8.1 for FAR
13.13.2
Upgrading BI Publisher Periodic Reports from 8.0 to 8.1 for FAR
14
Installing End of Study Unblinding
14.1
EOSU Hardware/Software Requirements
14.2
How to Install the EOSU Utility
15
Other Tasks
15.1
Configuring the Argus.xml File
15.2
Configuring the Argus.ini File
15.2.1
Increasing the Internet Explorer Timeout Setting to Run Reports
15.3
Deploying a Portlet on Oracle WebLogic Server
15.4
Deploying the Global Home Application on a WebLogic Server
15.4.1
Configure Global Homepage Properties File
15.4.1.1
Update Global Homepage Properties File
15.4.1.2
Deploy Company Logo
15.4.2
Pre-Deployment Configuration
15.5
Configuring SSO in Oracle Access Manager 11g
15.6
Installation and Configuration of Oracle Web Tier Suite
15.6.1
Installing Oracle Web Tier
15.6.2
Configuring Oracle Web Tier
15.6.3
Oracle Http Server Administration
15.6.4
Configuring Oracle Http Server as Reverse Proxy Server for WebLogic
15.7
Configuring the WebCenter Security Provider for Identity Assertion
15.7.1
Configuring the Oracle Internet Directory Authenticator
15.7.2
Configuring the OAM Identity Asserter
15.7.3
Configuring the Default Authenticator and Setting the Order of Providers
15.7.4
Setting EXTRA_JAVA_PROPERTIES for WebLogic Domain
15.8
Installation Maintenance Tasks
15.8.1
Installing New Components
15.8.2
Uninstalling Components
15.8.3
Removing All Components
15.9
Web Client Tips
15.10
Clearing Oracle Temp Files
15.11
Configuring easyPDF
15.11.1
Setting Up easyPDF
15.11.2
Setting up Microsoft Office
15.11.3
Using Display PDF in Browser
15.12
Setting Printer Defaults
15.13
Argus Configuration Files
16
Argus Integrations
16.1
Installing Argus Integrations
16.2
Resetting IIS
16.3
Overview: Argus Web Service Interface
16.3.1
Argus Web Service Interface Framework
16.4
Basic Configuration Overview
16.4.1
Outbound Interface
16.4.2
Inbound Interface
16.5
Safety Message Overview
16.6
MedDRA Interface
16.6.1
Overview
16.6.2
MedDRA Encoding Safety Message Example
16.6.2.1
Request (V 1.1)
16.6.2.2
Response (V 1.1)
16.6.2.3
Request (V 1.0)
16.6.2.4
Response (V 1.0)
16.6.3
MedDRA Dictionary: XML Schema
16.6.3.1
Request: MEDDRA_Request
16.6.3.2
Request: MEDDRA_Response
16.6.4
Flow of MedDRA Auto Encoding
16.6.5
Configuration
16.7
Product License Study Interface
16.8
WHO Drug Coding Interface
16.8.1
Overview
16.8.2
WHO Drug Coding Safety Message Example
16.8.2.1
Request
16.8.2.2
Response
16.8.3
WHO Drug Coding: XML Schema
16.8.3.1
Request: WHODrug_Request
16.8.3.2
Response: WHODrug_Response
16.8.4
Flow of Drug Dictionary Coding
16.8.5
Configuration
16.9
Lot Number Interface
16.9.1
Overview
16.9.2
Lot Number Safety Message Example
16.9.2.1
Request
16.9.2.2
Response
16.9.3
Lot Number: XML Schema
16.9.3.1
Request: Lot_Request
16.9.3.2
Response: Lot_Response
16.9.4
Flow of Lot Validation
16.9.5
Configuration
16.9.6
Transformation
16.10
Worklist Intake
16.10.1
Flow of Worklist Intake
16.10.2
Worklist Intake Safety Message Example
16.10.3
Configuration
16.11
Literature Intake
16.11.1
Flow of Literature Intake
16.11.2
Configuration
16.11.2.1
Metadata Configuration
16.12
Extended E2B Interface
16.12.1
E2B Mapping Updates
16.12.2
Adding Extension Elements to DTD
16.12.3
Prepare Factory Data for Extension Elements
16.12.4
Create Business Logic for Extension Elements
16.12.5
Configure Reporting Destination for Extension Profile
16.12.6
Extension Elements Sample XML
16.12.7
Extension Elements Sample Import PL/SQL Block
17
Argus Password Management - Cryptography Tool
17.1
Cryptography Tool Overview
17.2
Installing or Upgrading to Argus Safety 8.1
17.2.1
The Argus Safety 8.1 Database
17.2.2
The Argus Safety 8.1 Application Servers
17.2.3
Generating a New Cryptography Key
17.3
Resetting Password / Changing the Cryptography Key
17.3.1
Resetting the ARGUSUSER Password
17.3.2
Editing Keys
17.3.3
Re-encrypting Common User Passwords
17.3.4
Generating Encrypted String from Clear Text on Configured User Cryptography Key
17.3.5
Resetting the Environment if ArgusSecureKey.ini is Lost
18
Argus Centralized Coding
18.1
setup_centralized_coding_interface_schema.bat
18.2
setup_dsnav_centralized_coding.bat
18.3
dms_migration.bat
18.3.1
Single Enterprise Migration in One Execution
18.3.2
All Enterprise Migration in One Execution
