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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
Revision History
Part I Prepare to Install Argus
1
System Requirements
1.1
Hardware Requirements
1.2
Software Requirements
1.2.1
Operating System
1.2.2
Oracle Components
1.2.3
Other Components
1.2.4
Generic—Other Supported Features
1.2.5
General Installation Notes and Information
2
Install Oracle Database
2.1
Get the Oracle Database Installation Guide
2.2
Install Oracle Database
2.2.1
Database Software Installation Options
2.2.2
Database Configuration Options
2.2.3
Install and Apply Oracle Patch Set
2.3
Set Up Argus Safety Database Parameters
2.3.1
Argus Safety Database Instance Parameters (Recommended)
2.3.2
Additional Database Setup Information
2.4
Argus Insight Configuration Requirements
2.4.1
Database Parameters
2.4.2
Database I/O Configuration
2.4.3
Recommended Configuration for the Database Server
Part II Set Up Argus Middle and Client Tiers
3
Install and Configure Argus Safety Web
3.1
Prerequisites
3.2
Install Argus Safety Web
3.3
Configure Load Balancer in Argus Web
3.3.1
Set Up Argus Web Load Balancer IP Address
3.3.2
Set Up Shared Network Directory
3.4
Reset IIS
4
Install Argus Insight
4.1
Install Argus Insight Components onto the Web Server
4.1.1
Change the APR_USER Password
4.2
Enable SSL Support for the Argus Insight Website
5
Configure Web Service Interfaces on Web Server
5.1
Argus Web Service Interface
5.1.1
Argus Web Service Interface Framework
5.2
Edit .config Files
5.2.1
Edit the .config file for Outbound Interfaces
5.2.2
Edit the .config file for Inbound Interface
5.3
Safety Message
5.4
MedDRA Interface
5.4.1
MedDRA Configuration
5.4.1.1
Enable MedDRA Integration through Argus Console
5.4.1.2
Edit the ArgusWeb/ASP/web.config file
5.4.1.3
Edit the Argus.NET/web.config file
5.4.2
MedDRA Encoding Flow
5.4.3
MedDRA Interface XML Schema
5.4.3.1
MEDDRA_Request
5.4.3.2
MEDDRA_Response
5.5
Product Study License Interface
5.6
WHO Drug Coding Interface
5.6.1
Configuration
5.6.2
Drug Dictionary Coding Flow
5.6.3
WHO Drug Coding: XML Schema
5.6.3.1
Request: WHODrug_Request
5.6.3.2
Response: WHODrug_Response
5.7
Lot Number Interface
5.7.1
Configuration
5.7.2
Lot Validation Flow
5.7.3
Lot Number: XML Schema
5.7.3.1
Request: Lot_Request
5.7.3.2
Response: Lot_Response
5.7.4
Transformation
5.8
Worklist Intake
5.8.1
Configuration
5.8.2
Worklist Intake Flow
5.9
Literature Intake
5.9.1
Configuration
5.9.1.1
Metadata Configuration
5.9.2
Literature Intake Flow
5.10
Extended E2B Interface
6
Install and Start Argus Safety Service
6.1
Install Argus Safety Service
6.2
Start Argus Safety Service
7
Install and Configure Interchange
7.1
Prerequisites
7.2
Install Interchange Service
7.3
Configure Interchange Service
7.4
Access EDI Gateway Shared Folders
7.5
Configure Interchange Service .INI File
8
Configure the Argus Insight Application
8.1
Log In to Argus Insight for Configuration and Setup
8.2
Configure the Argus Insight Application Profile Switches
8.2.1
Access and Modify the Profile Switches
8.2.2
Set Up the Populate Data Attributes
8.2.3
Set Up the Email Attributes
8.2.4
Set Up the Attributes Specific ONLY to Argus Mart
8.2.5
Set Up the Attributes Specific ONLY to BIP
8.2.6
Set Up the Attributes Specific ONLY to OBIEE
8.3
Configure Duration Value Bands
8.4
Configure Derivation Functions
8.4.1
Open the Derivation Fields Dialog Box
8.4.2
Icons in the Derivation Fields Dialog Box
8.4.3
Field Mapping Derivation Rules
8.4.4
Fields and Check Boxes in the Derivation Fields Dialog Box
8.4.4.1
LM Table
8.4.4.2
Suppress
8.4.4.3
Value
8.4.4.4
Priority
8.4.4.5
SQL
8.5
Configure the Argus Insight Windows Service
8.6
Configure the IIS File Download Limit
8.6.1
Configure the Maximum Requesting Entity Body Limit
8.7
Use Export and Import to Copy Configuration Data
8.7.1
Export Data
8.7.2
Import Data
8.8
Use Argus Safety to Configure Enterprises for Argus Insight (for Mutli-tenant installation only)
8.9
Secure Sensitive Configuration and Operational Data
9
Upgrade the Argus Application
9.1
Upgrade Argus Application on the Web Server
9.2
Upgrade Argus Application on the Transaction Server
10
Set Up the Client Browser
10.1
Prerequisite
10.2
Install Files Required to View Reports
10.3
Configure Internet Explorer
10.4
Post Application Install or Upgrade
10.5
Add the Argus Site as a Local Intranet Site
10.6
Add Argus Site to the Enterprise Mode
10.7
Set Up Compatibility View with Internet Explorer
11
Post-installation Checks
11.1
Post-Installation Tasks
11.1.1
General Checklist
11.1.2
Configure Worklist Intake on the Web Server
11.1.2.1
RelsysWindowsService.exe.config
11.1.2.2
Service.config
11.1.2.3
Intake.config
11.1.3
Verify and Update Network Proxy Settings
11.2
Verify Files Installed on Middle Tier Servers
12
Other Tasks
12.1
Configure Argus.xml File
12.2
Configure Argus.ini File
12.2.1
Argus.ini Parameters
12.3
Installation Maintenance Tasks
12.3.1
Install New Components
12.3.2
Uninstall Components
12.3.3
Remove All Components
12.4
Argus Configuration Files
12.4.1
Backup Configuration Files
Part III Install or Upgrade Argus Database Tier
13
Install Argus Safety Database
13.1
Create Argus Safety Database Schema
13.1.1
Prepare to execute the DBInstaller
13.1.1.1
Prerequisites
13.1.1.2
Install Java
13.1.1.3
Set Java Install Path
13.1.1.4
Install XDB Schema for Interchange
13.1.2
Run Create DBA User Script
13.1.3
Create Tablespaces (Optional)
13.1.4
Prerequisites to Create the Schema
13.1.5
Configure the Database Setup Properties File
13.1.6
Create the Schema on Windows from the User Interface
13.1.7
Create the Schema on Windows from a Batch file
13.1.8
Create the Schema on Linux or Unix
13.2
Post Fresh Install Steps
13.3
Validate Argus Safety Database
13.3.1
Validate Argus Safety Database on Windows
13.3.2
Validate Argus Safety Database on Linux or Unix
13.4
Enable and Disable Data Lock Point (DLP)
13.4.1
Prerequisites
13.4.2
Enable DLP
13.4.3
Disable DLP
13.5
Enable DLP on a Specific Enterprise
13.5.1
Set Up the Base Database
13.5.2
Enable DLP on Specific Enterprise or Delta Cases
13.5.3
Validate the Schema
13.6
Copy Configuration Data (Optional)
13.6.1
Set Up the Copy Configuration Tool
13.6.2
Use the Copy Configuration Tool
13.7
Create Argus Safety Read-only Database Account (Optional)
14
Upgrade Argus Safety Database
14.1
Prerequisites for Database Upgrade
14.2
Argus Safety Database Upgrade
14.3
Post Upgrade Steps
14.4
Enable Local Locking in Argus Safety
14.5
Merge a Single Enterprise Safety Database into a Multi-tenant Database
14.5.1
Prerequisites to Run the Merge Export Step
14.5.2
Merge Export
14.5.3
Export the dmp File Copy to the Target Database Server
14.5.4
Prerequisites to Run the Merge Import Step
14.5.5
Merge Import
14.5.6
Synchronize Dictionary Manually
15
Create the Argus Insight Data Mart Structure
15.1
Before You Run the Argus Insight Installation
15.2
Configure dbinstaller.properties file
15.3
Create Argus Insight Database Schema
15.3.1
Prerequisites
15.3.2
Create Users in the Argus Safety Database
15.3.3
Create the DBA User
15.3.4
Create Fresh Argus Insight Schema
15.3.5
Validate the Schema
15.3.6
Create Argus Insight Read-only User
15.4
Create Database Links
15.4.1
From Argus Safety to Argus Insight Database
15.4.2
From Argus Insight to Argus Safety (manually)
15.5
Run Initial ETL
15.6
Run Additional Grant Scripts for Single DB Instance
16
Upgrade the Argus Insight Data Mart Structure
16.1
Prepare for Database Upgrade
16.2
Upgrade Database
Part IV Configure Other Products
17
Configure and Enable Argus Dossier
17.1
Prerequisites
17.2
Configure Dossier
17.3
Enable Dossier
18
Install and Configure Axway B2Bi
18.1
Create an Axway B2Bi Database Instance
18.2
Install Axway B2Bi
18.3
Configure Axway B2Bi
18.3.1
Configure Axway B2Bi for Binary File Transmission
18.3.2
Configure Axway B2Bi Community
18.3.2.1
Register with the Axway B2Bi Community
18.3.2.2
Add a Partner to the Axway B2Bi Community
18.3.2.3
Register the Receiver's Community on the Sender Server
18.3.3
Add a Node
18.3.4
Configure Axway B2Bi Certificates
18.3.4.1
Configure Receiver Axway B2Bi Certificates
18.3.4.2
Configure Sender Axway B2Bi Certificates
18.3.5
Configuring EVENTS.XML
18.3.6
Configure Message Processing Settings
18.4
Test Communication
19
Install and Configure Oracle B2B
19.1
Install Oracle B2B
19.2
Integrate Oracle B2B with Argus Safety
19.3
Create Integration tables in B2B Schema
19.4
Configure Oracle B2B User Interface
19.4.1
General Configuration > Administration > Configuration
19.4.2
Document Configuration > Administration > Document
19.5
Configure Enterprise Manager
19.5.1
Deploy SOA Composite
19.5.2
Configure SOA Composite
19.5.2.1
AS_BPEL_Outbound Composite
19.5.2.2
AS_BPEL_Inbound Composite
19.6
Configure Web Logic Console
19.6.1
Data source with JNDI Name as 'eis/DB/ArgusSafety_Outbound'
19.6.2
Data source as 'jdbc/ArgusSafety_Inbound'
19.6.3
Data source with JNDI Name as 'eis/DB/ArgusSafety_Inbound'
19.6.4
DB Adapters for Data Source
19.7
Configure Large Payload Exchange
19.7.1
Outbound Files
19.7.2
Inbound Files
19.7.3
Transaction Time
19.7.4
General B2B Settings for Large Payloads
19.8
Configurations for Argus Safety
19.8.1
Configure Oracle B2B
19.8.2
Update for B2B Documents
19.8.3
Argus Console > Reporting Destination Code List
20
Configure OBIEE or BI Publisher
20.1
Prepare BI Publisher Server
20.2
Set Up BI Publisher for Argus Safety
20.2.1
Enable a Local Superuser
20.2.2
Create a Database Connection
20.2.3
Set Up Runtime BI Publisher Time-out
20.2.4
Configure Oracle Fusion Middleware Security Model
20.3
Manage Users and Roles
20.3.1
Configure Users, Groups and Roles
20.3.1.1
Create a Group
20.3.1.2
Create a User
20.3.1.3
Create an Application Role
20.3.2
Create Application Policies and Set Up Folder Privileges (BI Publisher Standalone only)
20.3.2.1
Create Application Policies
20.3.2.2
Manage Folder Privileges
20.3.3
Create Application Policies and Set Up Folder Privileges (OBIEE and BI Integrated Installation only)
20.3.3.1
Create Application Policies
20.3.3.2
Manage Folder Privileges
20.4
Upload BI Publisher Reports
20.4.1
Flexible Aggregate Reports
20.4.2
PMDA R3 Paper Reports
20.5
Integrate Argus Safety with BI Publisher
20.5.1
Configure AG Service
20.5.2
Configure Web Service (Expedited Reports only)
20.5.3
Add AG Service user to BI Publisher (Expedited Reports only)
20.5.4
Update SSO Exclusion List
20.6
Argus Console—BIP Common Settings
20.6.1
Configure BIP Reporting Admin User
20.6.2
Enable BIP Aggregate Reports and Configure Persistence Data (Flexible Aggregate Reporting only)
20.6.3
Configure Code Lists
20.6.3.1
Flexible Aggregate Reporting Code Lists
20.6.3.2
PMDA R3 Paper Forms Code lists
20.7
Configure Flexible Aggregate Reporting Database
20.7.1
Execute Argus_BIP_Enable
20.8
Upgrade BIP Reports to 8.2.2
21
Configure the BIP Environment for Argus Insight
21.1
Create PRMART JDBC Connection
21.2
Manage Users and Roles: BI Publisher Standalone Installation with BI Publisher Security
21.2.1
Create Users and Assign Roles to Users
21.2.2
Create Roles, Add Data Sources, and Assign Roles
21.3
Manage Users and Roles: BI Publisher Standalone Installation with OFM Security
21.3.1
Create Users and Assign Roles to Users
21.3.2
BI Publisher Standalone Installation in OFM Security
21.3.2.1
Create Users and Groups
21.3.2.2
Create Roles and Policies
21.3.3
Create Roles, Adding Data Sources, and Assign Roles in WebLogic Enterprise Manager
21.3.4
Create Application Policy
21.3.5
Upload the Argus Insight.xdrz file to BIP
21.4
Configure BIP Users and Roles: Oracle Fusion Middleware Security Model
21.4.1
Configure BIP Roles
21.4.2
Folder Level Permissions
22
Configure the OBIEE Environment for Argus Insight
22.1
Pre-installation Configuration
22.2
Configure the OBIEE Repository and Web Catalog using the BAR File
22.2.1
Import the BAR file in an existing OBIEE instance
22.2.2
Import the BAR file to create a new OBIEE Instance
22.3
Configure OBIEE Repository and Web Catalog Manually
22.4
Create Users and Groups in OBIEE
22.4.1
Create Users and Groups in WebLogic Server
22.4.2
Create Roles and Policies with Fusion Middleware Control
22.5
OBIEE Catalog Folder-level Permissions
22.6
OBIEE Default Application Roles
23
Install Argus Unblinding
23.1
Prerequisites
23.2
Install Argus Unblinding Utility
24
Configure Argus Centralized Coding
24.1
setup_centralized_coding_interface_schema.bat
24.2
dms_migration.bat
24.2.1
Single Enterprise Migration in One Execution
24.2.2
All Enterprise Migration in One Execution
25
Extract, Transform, and Load Data
25.1
Prerequisites, Cautions, and Warnings
25.2
Run the Initial ETL
25.2.1
Generate the Balance Logs
25.2.2
Close the Initial ETL Status Dialog Box
25.2.3
Stop the Execution of ETL
25.3
Run the Initial ETL Again
25.4
Process a Failed ETL
25.4.1
Continue the Failed Initial ETL Process
25.4.2
Ignore the Failed Initial ETL Process
25.4.3
Modify the Attributes of ETL Data Exclusion
25.5
Restart the Initial ETL Process
Part V Secure Oracle Argus
26
Argus Password Management—Cryptography Tool
26.1
Install or Upgrade to Argus Safety 8.2.2
26.1.1
Generate New Cryptography Key
26.1.2
Argus Safety Database
26.1.3
Argus Safety Application Servers
26.2
Reset Password or Change the Cryptography Key
26.2.1
Reset the ARGUSUSER Password
26.2.2
Edit Keys
26.2.3
Re-encrypt Common User Passwords
26.2.4
Generate Encrypted String
26.2.5
Reset Administrator and System Application User Password
26.2.6
Reset the Environment if ArgusSecureKey.ini is Lost
26.3
Manage Argus Insight Cryptographic Key
26.3.1
Update APR_USER Password
26.3.2
Copy Initialization Files to Other Servers
26.3.3
Restart IIS and Run ETL
A
Configure BI Publisher Security Model
A.1
Create Custom Roles and Assign Data Sources
A.2
Create Users and Assign Roles
B
Create ODBC Connection for OBIEE Administration Tool for Argus Insight
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