Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Related resources
  • Access to Oracle Support
  • Revision History
• Part I Prepare to Install Oracle Argus Safety
  • 1 System Requirements
    • Hardware Requirements
    • Software Requirements
      • Operating System
      • Oracle Components
      • Other Components
      • Generic—Other Supported Features
      • General Installation Notes and Information
  • 2 Install Oracle Database
    • Get the Oracle Database Installation Guide
    • Install Oracle Database
      • Database Software Installation Options
      • Database Configuration Options
      • Install and Apply Oracle Patch Set
    • Set Up Oracle Argus Safety Database Parameters
      • Oracle Argus Safety Database Instance Parameters (Recommended)
      • Additional Database Setup Information
    • Oracle Argus Insight Configuration Requirements
      • Database Parameters
      • Database I/O Configuration
      • Recommended Configuration for the Database Server
• Part II Set Up Argus Middle and Client Tiers
  • 3 Install and Configure Oracle Argus Safety Web
    • Prerequisites
    • Install Oracle Argus Safety Web
    • Configure Load Balancer in Oracle Argus Safety Web
      • Set Up Oracle Argus Safety Web Load Balancer IP Address
      • Set Up Shared Network Directory
    • Reset IIS
  • 4 Install Oracle Argus Insight
    • Install Oracle Argus Insight Components onto the Web Server
      • Change the APR_USER Password
    • Enable SSL Support for the Oracle Argus Insight Website
  • 5 Configure Web Service Interfaces on Web Server
    • Oracle Argus Safety Web Service Interface
      • Oracle Argus Safety Web Service Interface Framework
    • Edit .config Files
      • Edit the .config file for Outbound Interfaces
      • Edit the .config file for Inbound Interface
    • Safety Message
    • MedDRA Interface
      • MedDRA Configuration
        • Enable MedDRA Integration through Oracle Argus Safety Console
        • Edit the ArgusWeb/ASP/web.config file
        • Edit the Argus.NET/web.config file
      • MedDRA Encoding Flow
      • MedDRA Interface XML Schema
        • MEDDRA_Request
        • MEDDRA_Response
    • Product Study License Interface
    • WHO Drug Coding Interface
      • Configuration
      • Drug Dictionary Coding Flow
      • WHO Drug Coding: XML Schema
        • Request: WHODrug_Request
        • Response: WHODrug_Response
    • Lot Number Interface
      • Configuration
      • Lot Validation Flow
      • Lot Number: XML Schema
        • Request: Lot_Request
        • Response: Lot_Response
      • Transformation
    • Worklist Intake
      • Configuration
      • Worklist Intake Flow
    • Literature Intake
      • Configuration
        • Metadata Configuration
      • Literature Intake Flow
    • Extended E2B Interface
  • 6 Install and Start Oracle Argus Safety Service
    • Install Oracle Argus Safety Service
    • Start Oracle Argus Safety Service
  • 7 Install and Configure Oracle Argus Interchange
    • Prerequisites
    • Install Oracle Argus Interchange Service
    • Configure Oracle Argus Interchange Service
    • Access EDI Gateway Shared Folders
    • Configure Oracle Argus Interchange Service .INI File
  • 8 Configure the Oracle Argus Insight Application
    • Log In to Oracle Argus Insight for Configuration and Setup
    • Configure the Oracle Argus Insight Application Profile Switches
      • Access and Modify the Profile Switches
      • Set Up the Populate Data Attributes
      • Set Up the Email Attributes
      • Set Up the Attributes Specific ONLY to Oracle Argus Mart
      • Set Up the Attributes Specific ONLY to Oracle Business Intelligence Publisher
      • Set Up the Attributes Specific ONLY to Oracle Business Intelligence Enterprise Edition
    • Configure Duration Value Bands
      • Modify a Duration Value Band
    • Configure Derivation Functions
      • Open the Derivation Fields Dialog Box
      • Icons in the Derivation Fields Dialog Box
      • Field Mapping Derivation Rules
      • Fields and Check Boxes in the Derivation Fields Dialog Box
        • LM Table
        • Suppress
        • Value
        • Priority
        • SQL
    • Configure the Oracle Argus Insight Windows Service
    • Configure the IIS File Download Limit
      • Configure the Maximum Requesting Entity Body Limit
    • Use Export and Import to Copy Configuration Data
      • Export Data
      • Import Data
    • Use Oracle Argus Safety to Configure Enterprises for Oracle Argus Insight (for Mutli-tenant installation only)
    • Secure Sensitive Configuration and Operational Data
  • 9 Upgrade the Oracle Argus Safety Application
    • Upgrade Oracle Argus Safety Application on the Web Server
    • Upgrade Oracle Argus Safety Application on the Transaction Server
  • 10 Set Up the Client Browser
    • Prerequisite
    • Install Files Required to View Reports
    • Configure Internet Explorer
    • Post Application Install or Upgrade
    • Add the Oracle Argus Safety Site as a Local Intranet Site
    • Add Oracle Argus Safety Site to the Enterprise Mode
    • Set Up Compatibility View with Internet Explorer
  • 11 Post-installation Tasks
    • General Checklist
    • Configure Worklist Intake on the Web Server
      • RelsysWindowsService.exe.config
      • Service.config
      • Intake.config
    • Verify and Update Network Proxy Settings
    • Verify Files Installed on Middle Tier Servers
  • 12 Other Tasks
    • Configure Argus.xml File
    • Configure Argus.ini File
      • Argus.ini Parameters
    • Installation Maintenance Tasks
      • Install New Components
      • Uninstall Components
      • Remove All Components
    • Oracle Argus Safety Configuration Files
      • Backup Configuration Files
• Part III Install or Upgrade Oracle Argus Safety Database Tier
  • 13 Install Oracle Argus Safety Database
    • Create Oracle Argus Safety Database Schema
      • Prepare to execute the DBInstaller
        • Prerequisites
        • Install Java
        • Set Java Install Path
        • Install XDB Schema for Oracle Argus Interchange
      • Run Create DBA User Script
      • Create Tablespaces (Optional)
      • Prerequisites to Create the Schema
      • Configure the Database Setup Properties File
      • Create the Schema on Windows from the User Interface
      • Create the Schema on Windows from a Batch file
      • Create the Schema on Linux or Unix
    • Post Fresh Install Steps
    • Validate Oracle Argus Safety Database
      • Validate Oracle Argus Safety Database on Windows
      • Validate Oracle Argus Safety Database on Linux or Unix
    • Enable and Disable Data Lock Point (DLP)
      • Prerequisites
      • Enable DLP
      • Disable DLP
    • Enable DLP on a Specific Enterprise
      • Set Up the Base Database
      • Enable DLP on Specific Enterprise or Delta Cases
      • Validate the Schema
    • Copy Configuration Data (Optional)
      • Set Up the Copy Configuration Tool
      • Use the Copy Configuration Tool
    • Create Oracle Argus Safety Read-only Database Account (Optional)
  • 14 Upgrade Oracle Argus Safety Database
    • Prerequisites for Database Upgrade
    • Oracle Argus Safety Database Upgrade
    • Post Upgrade Steps
    • Enable Local Locking in Oracle Argus Safety
    • Merge a Single Enterprise Safety Database into a Multi-tenant Database
      • Prerequisites to Run the Merge Export Step
      • Merge Export
      • Export the dmp File Copy to the Target Database Server
      • Prerequisites to Run the Merge Import Step
      • Merge Import
      • Synchronize Dictionary Manually
  • 15 Create the Oracle Argus Insight Data Mart Structure
    • Before You Run the Oracle Argus Insight Installation
      • Review and Modify the Database Settings
      • Create a DBA user
    • Configure dbinstaller.properties file
    • Create Oracle Argus Insight Database Schema
      • Prerequisites
        • Install Java
        • Set Java Installation Path
      • Create Users in the Oracle Argus Safety Database
      • Create the DBA User
      • Create Fresh Oracle Argus Insight Schema
      • Validate the Schema
      • Create Oracle Argus Insight Read-only User
    • Create Database Links
      • From Oracle Argus Safety to Oracle Argus Insight Database
      • From Oracle Argus Insight to Oracle Argus Safety (manually)
    • Run Initial ETL
    • Run Additional Grant Scripts for Single DB Instance
  • 16 Upgrade the Oracle Argus Insight Data Mart Structure
    • Prepare for Database Upgrade
    • Upgrade Database
• Part IV Configure Other Products
  • 17 Configure and Enable Oracle Argus Dossier
    • Prerequisites
    • Configure Oracle Argus Dossier
    • Enable Oracle Argus Dossier
  • 18 Install and Configure Axway B2Bi
    • Create an Axway B2Bi Database Instance
    • Install Axway B2Bi
    • Configure Axway B2Bi
      • Configure Axway B2Bi for Binary File Transmission
      • Configure Axway B2Bi Community
        • Register with the Axway B2Bi Community
        • Add a Partner to the Axway B2Bi Community
        • Register the Receiver's Community on the Sender Server
      • Add a Node
      • Configure Axway B2Bi Certificates
        • Configure Receiver Axway B2Bi Certificates
        • Configure Sender Axway B2Bi Certificates
      • Configure EVENTS.XML
        • Configure Event.xml on client machine
        • Configure Event.xml on receiver machine
      • Configure Message Processing Settings
    • Test Communication
  • 19 Install and Configure Oracle B2B
    • Install Oracle B2B
    • Integrate Oracle B2B with Oracle Argus Safety
    • Create Integration tables in Oracle B2B Schema
    • Configure Oracle B2B User Interface
      • General Configuration > Administration > Configuration
      • Document Configuration > Administration > Document
    • Configure Oracle Enterprise Manager
      • Deploy SOA Composite
      • Configure SOA Composite
        • AS_BPEL_Outbound Composite
        • AS_BPEL_Inbound Composite
    • Configure Web Logic Console
      • 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'
      • DB Adapters for Data Source
    • Configure Large Payload Exchange
      • Outbound Files
      • Inbound Files
      • Transaction Time
      • General Oracle B2B Settings for Large Payloads
    • Configurations for Oracle Argus Safety
      • Configure Oracle B2B
      • Update for Oracle B2B Documents
      • Argus Console > Reporting Destination Code List
  • 20 Configure Oracle Business Intelligence Enterprise Edition or Oracle Business Intelligence Publisher
    • Prepare Oracle Business Intelligence Publisher Server
    • Set Up Oracle Business Intelligence Publisher for Oracle Argus Safety
      • Enable a Local Superuser
      • Create a Database Connection
      • Set Up Runtime Oracle Business Intelligence Publisher Time-out
      • Configure Oracle Fusion Middleware Security Model
    • Manage Users and Roles
      • Configure Users, Groups and Roles
        • Create a Group
        • Create a User
        • Create an Application Role
      • Create Application Policies and Set Up Folder Privileges (Oracle Business Intelligence Publisher Standalone only)
        • Create Application Policies
        • Manage Folder Privileges
      • Create Application Policies and Set Up Folder Privileges (Oracle Business Intelligence Enterprise Edition and Oracle Business Intelligence Integrated Installation only)
        • Create Application Policies
        • Manage Folder Privileges
    • Upload Oracle Business Intelligence Publisher Reports
      • Flexible Aggregate Reports
      • PMDA R3 Paper Reports
    • Integrate Oracle Argus Safety with Oracle Business Intelligence Publisher
      • Configure AG Service
      • Configure Web Service (Expedited Reports only)
      • Add AG Service user to BI Publisher (Expedited Reports only)
      • Update SSO Exclusion List
    • Oracle Argus Safety Console—Oracle Business Intelligence Publisher Common Settings
      • Configure Oracle Business Intelligence Publisher Reporting Admin User
      • Enable Oracle Business Intelligence Publisher Aggregate Reports and Configure Persistence Data (Flexible Aggregate Reporting only)
      • Configure Code Lists
        • Flexible Aggregate Reporting Code Lists
        • PMDA R3 Paper Forms Code lists
    • Configure Flexible Aggregate Reporting Database
      • Execute Argus_BIP_Enable
    • Upgrade Oracle Business Intelligence Publisher Reports to 8.2.2
  • 21 Configure the Oracle Business Intelligence Publisher Environment for Oracle Argus Insight
    • Create PRMART JDBC Connection
    • Manage Users and Roles: Oracle Business Intelligence Publisher Standalone Installation with Oracle Business Intelligence Publisher Security
      • Create Users and Assign Roles to Users
      • Create Roles, Add Data Sources, and Assign Roles
    • Manage Users and Roles: Oracle Business Intelligence Publisher Standalone Installation with Oracle Fusion Middleware Security
      • Create Users and Assign Roles to Users
      • Oracle Business Intelligence Publisher Standalone Installation in Oracle Fusion Middleware Security
        • Create Users and Groups
        • Create Roles and Policies
      • Create Roles, Adding Data Sources, and Assign Roles in WebLogic Oracle Enterprise Manager
      • Create Application Policy
      • Upload the Argus Insight.xdrz file to Oracle Business Intelligence Publisher
    • Configure Oracle Business Intelligence Publisher Users and Roles: Oracle Fusion Middleware Security Model
      • Configure Oracle Business Intelligence Publisher Roles
      • Folder Level Permissions
  • 22 Configure the Oracle Business Intelligence Enterprise Edition Environment for Oracle Argus Insight
    • Pre-installation Configuration
    • Configure the Oracle Business Intelligence Enterprise Edition Repository and Web Catalog using the BAR File
      • Import the BAR file in an existing Oracle Business Intelligence Enterprise Edition instance
      • Import the BAR file to create a new Oracle Business Intelligence Enterprise Edition Instance
    • Configure Oracle Business Intelligence Enterprise Edition Repository and Web Catalog Manually
    • Create Users and Groups in Oracle Business Intelligence Enterprise Edition
      • Create Users and Groups in Oracle WebLogic Server
      • Create Roles and Policies with Oracle Fusion Middleware Control
    • Oracle Business Intelligence Enterprise Edition Catalog Folder-level Permissions
      • Setup the Permissions through the Catalog Manager
    • Oracle Business Intelligence Enterprise Edition Default Application Roles
  • 23 Install Oracle Argus Unblinding
    • Prerequisites
    • Install Oracle Argus Unblinding Utility
  • 24 Configure Argus Centralized Coding
    • setup_centralized_coding_interface_schema.bat
      • Execute the Batch File
    • dms_migration.bat
      • Single Enterprise Migration in One Execution
      • All Enterprise Migration in One Execution
  • 25 Extract, Transform, and Load Data
    • Prerequisites, Cautions, and Warnings
    • Run the Initial ETL
      • Generate the Balance Logs
      • Close the Initial ETL Status Dialog Box
      • Stop the Execution of ETL
    • Run the Initial ETL Again
    • Process a Failed ETL
      • Continue the Failed Initial ETL Process
      • Ignore the Failed Initial ETL Process
      • Modify the Attributes of ETL Data Exclusion
    • Restart the Initial ETL Process
• Part V Secure Oracle Argus Safety
  • 26 Oracle Argus Safety Password Management—Cryptography Tool
    • Install or Upgrade to Oracle Argus Safety 8.2.2
      • Generate New Cryptography Key
      • Oracle Argus Safety Database
      • Oracle Argus Safety Application Servers
    • Reset Password or Change the Cryptography Key
      • Reset the ARGUSUSER Password
      • Edit Keys
      • Re-encrypt Common User Passwords
      • Generate Encrypted String
      • Reset Administrator and System Application User Password
      • Reset the Environment if ArgusSecureKey.ini is Lost
    • Manage Oracle Argus Insight Cryptographic Key
      • Update APR_USER Password
      • Copy Initialization Files to Other Servers
      • Restart IIS and Run ETL
• A Configure BI Publisher Security Model
  • Create Custom Roles and Assign Data Sources
  • Create Users and Assign Roles
• B Create ODBC Connection for OBIEE Administration Tool for Oracle Argus Insight