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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 Safety
1
System Requirements
1.1
Argus Safety Recommended Hardware Topology
1.1.1
Small Company
1.1.2
Mid-sized Company
1.1.3
Large Company
1.1.4
Hardware Requirements for Argus Safety
1.2
Software Requirements for Argus Safety
1.2.1
Operating System
1.2.2
Oracle Components
1.2.3
Other Components
1.2.4
Generic—Other Supported Features (Optional)
1.2.5
Oracle Advanced Security Transparent Data Encryption (TDE)
1.2.6
Install and Apply Oracle Patch
2
Install Oracle Database
2.1
Get the Oracle Database 12.1.0.2 Installation Guide
2.2
Download and Extract the Oracle Database 12.1.0.2 Software
2.3
Install Oracle Database 12.1.0.2
2.3.1
Database Software Options
2.3.2
Database Configuration Options
2.4
Set Up Database Parameters
2.4.1
Argus Safety Database Instance Parameters (Recommended)
2.4.2
Additional Database Setup Information
2.5
GMT Offset Calculation
2.6
Table Partitioning (Optional)
Part II Set Up Argus Safety Middle and Client Tiers
3
Install and Configure Argus Safety Web
3.1
Prerequisites
3.2
Install IIS 8.5
3.3
Install Argus Safety Web
3.4
Configure the IIS Manager for Windows Server 2012 R2 Standard
3.5
Connect to a Domain Account on Windows Server 2012 R2 Standard
3.6
Enable SSL Support for Windows Server 2012 R2 Standard
3.7
Configure Load Balancer in Argus Web
3.7.1
Set Up Argus Web Load Balancer IP Address
3.7.2
Set Up Load Balanced Folders
3.7.3
Set Up Shared Network Directory
3.8
Secure Sensitive Configuration and Operational Data
3.9
Configure Identity in the IIS Application Pools
3.10
Reset IIS
4
Enable IIS HTTP Compression
4.1
IIS Web Page Compression
4.1.1
HTTP Compression
4.1.2
Known Effects of Enabling Compression
4.1.3
Enable HTTP Compression
4.2
IIS Caching Settings
4.2.1
IIS Caching
4.2.2
Known Effects of Enabling Caching
4.2.3
Enable Caching
4.3
Local Internet Explorer (IE) Client Caching Settings
4.3.1
IE Client Caching
4.3.2
IE Client Caching—Tab Options
4.3.3
Enable IE Caching
5
Install and Start Argus Safety Service
5.1
Install Argus Safety Service
5.2
Start Argus Safety Service
5.3
Set Up RightFax
6
Install and Configure Interchange
6.1
Prerequisites
6.2
Install Interchange Service
6.3
Configure Interchange Service
6.3.1
Transmit E2B Attachments
6.4
Access EDI Gateway Shared Folders
6.5
Configure Interchange Service .INI File
7
Configure E-mail
7.1
Configure SMTP
7.2
Functions Affected by SMTP
7.2.1
Bulk Report Transmit E-mail
7.2.2
Autosignal E-mail
7.2.3
Fax E-mail
7.2.4
Fax Status E-mail
7.2.5
Priority E-mail
7.2.6
Dossier Notification E-mail
7.2.7
E-mail Sent by Interchange Service
8
Set Up the Client Browser
8.1
Prerequisites
8.2
Install Files Required to View Japanese Text (For Japanese installation only)
8.3
Configure Internet Explorer
8.4
Add the Argus Site as a Local Intranet Site
8.5
Add Argus Site to the Enterprise Mode
8.6
Set Up Compatibility View with Internet Explorer
8.7
Increase the Internet Explorer Timeout Setting to Run Reports
9
Post-installation Checks
9.1
Post-Installation Tasks
9.1.1
General Checklist
9.1.2
Configure Argus Safety Windows Service to run as a Domain User
9.1.3
Configure Worklist Intake
9.1.3.1
RelsysWindowsService.exe.config
9.1.3.2
Service.config
9.1.3.3
Intake.config
9.1.4
IIS Checklist
9.1.5
.INI File Checklist
9.1.6
Service Checklist
9.2
Verify Web Server Installation and IIS Configurations
9.2.1
Verify IIS Configuration
9.3
Verify Files installed on Middle Tier Servers
9.4
Verify Documentum Installation
9.4.1
Integrate Documentum Completely
9.4.2
Run Documentum on Argus Safety
10
Other Tasks
10.1
Convert Argus Safety Report Server to Argus Web Server
10.2
Configure Argus.xml File
10.3
Configure Argus.ini File
10.3.1
Argus.ini—Parameters
10.4
Install SSO on Oracle Access Manager 11g
10.5
Installation Maintenance Tasks
10.5.1
Install New Components
10.5.2
Uninstall Components
10.5.3
Remove All Components
10.6
Set Up easyPDF
10.6.1
Configure Windows Service Settings
10.6.2
Display PDF in Browser
10.7
Set Up Printer Defaults
10.8
Argus Configuration Files
10.8.1
Backup Configuration Files
Part III Install or Upgrade Argus Safety Database Tier
11
Install Argus Safety Database
11.1
Create Argus Safety Database Schema
11.1.1
Prepare to Install Schema Creation Tool
11.1.1.1
Prerequisites
11.1.1.2
Install Java
11.1.1.3
Set Java Install Path
11.1.1.4
Install XDB Schema for Interchange
11.1.2
Install the Schema Creation Tool
11.1.3
Run Create DBA User Script
11.1.4
Create Tablespaces (Optional)
11.1.5
Prerequisites to Create the Schema
11.1.6
Validate the Database Setup Properties File
11.1.7
Create the Schema on Windows from the User Interface
11.1.8
Create the Schema on Windows from a Batch file
11.1.9
Create the Schema on Linux or Unix
11.2
Post Fresh Install Steps
11.3
Oracle Text
11.4
Validate Argus Safety Database
11.4.1
Validate Argus Safety Database on Windows from a User Interface
11.4.2
Validate Argus Safety Database on Windows from a Batch file
11.4.3
Validate Argus Safety Database on Linux or Unix
11.5
Enable and Disable Dat a Lock Point (DLP)
11.5.1
Prerequisites
11.5.2
Enable DLP
11.5.3
Disable DLP
11.6
Enable DLP on a Specific Enterprise
11.6.1
Set Up the Base Database
11.6.2
Enable DLP on Specific Enterprise or Delta Cases
11.6.3
Validate the Schema
11.7
Copy Configuration Data (Optional)
11.7.1
Set Up the Copy Configuration Tool
11.7.2
Use the Copy Configuration Tool
11.8
Create Argus Safety Read-only Database Account (Optional)
12
Upgrade Argus Safety Database
12.1
Prerequisites for Database Upgrade
12.2
Argus Safety Database Upgrade
12.3
Post Upgrade Steps
12.4
Populate J License under Case Form—PMDA tab
12.5
Enable Local Locking in Argus Safety
12.6
Merge a Single Enterprise Safety Database into a Multi-tenant Database
12.6.1
Prerequisites to Run the Merge Export Step
12.6.2
Merge Export
12.6.3
Export the dmp File Copy to the Target Database Server
12.6.4
Prerequisites to Run the Merge Import Step
12.6.5
Merge Import
12.6.6
Synchronize Dictionary Manually
13
Work with the Dictionaries
13.1
MedDRA Dictionary
13.1.1
Prerequisites
13.1.2
Load MedDRA or MedDRA J Dictionary
13.1.3
Overwrite an Existing MedDRA or MedDRA J Dictionary
13.1.4
Recode MedDRA
13.1.4.1
Run the Schema Creation Tool to Recode Events
13.2
WHO-Drug Dictionary
13.2.1
Prerequisites
13.2.2
Load WHO-DRUG Dictionary to New Tables
13.2.3
Overwrite an Existing WHO-Drug Dictionary
13.2.4
Load WHO-Drug Format C Dictionary
13.3
J Drug Dictionary
13.3.1
Prerequisites
13.3.2
Create and Modify Required File
13.3.2.1
create All_Data.txt file
13.3.2.2
Create formulationcode.txt file
13.3.2.3
Create drugnameenglish.txt file
13.3.2.4
Modify the.MDB file
13.3.3
Load J Drug Dictionary
13.3.4
Overwrite an Existing J Drug Dictionary
Part IV Configure Other Products
14
Configure and Enable Argus Dossier
14.1
Prerequisites
14.2
Configure Dossier
14.3
Verify Dossier Installation
14.4
Enable Dossier
15
Install and Configure Axway Synchrony
15.1
Create an Axway Synchrony Database Instance
15.2
Install Axway Synchrony Interchange
15.3
Start the Axway Synchrony Server
15.4
Configure Axway Synchrony Interchange for Axway 5.12
15.4.1
Configure Axway Synchrony for Binary File Transmission
15.4.2
Configure Axway Synchrony Community
15.4.2.1
Register with the Axway Synchrony Community
15.4.2.2
Add a Partner to the Axway Synchrony Community
15.4.2.3
Register the Receiver's Community on the Sender Server
15.4.3
Add a Node
15.4.4
Configure Axway Synchrony Certificates
15.4.4.1
Configure Receiver Axway Synchrony Certificates
15.4.4.2
Configure Sender Axway Synchrony Certificates
15.4.5
Configuring EVENTS.XML
15.5
Test Communication
16
Install and Configure Oracle B2B
16.1
Install Oracle B2B
16.2
Integrate Oracle B2B with Argus Safety
16.3
Create Integration tables in B2B Schema
16.4
Configure Oracle B2B User Interface
16.4.1
General Configuration > Administration > Configuration
16.4.2
Document Configuration > Administration > Document
16.5
Configure Enterprise Manager
16.5.1
Deploy SOA Composite
16.5.2
Configure SOA Composite
16.5.2.1
AS_BPEL_Outbound Composite
16.5.2.2
AS_BPEL_Inbound Composite
16.6
Configure Web Logic Console
16.6.1
Data source with JNDI Name as 'eis/DB/ArgusSafety_Outbound'
16.6.2
Data source as 'jdbc/ArgusSafety_Inbound'
16.6.3
Data source with JNDI Name as 'eis/DB/ArgusSafety_Inbound'
16.6.4
DB Adapters for Data Source
16.7
Configure Large Payload Exchange
16.7.1
Outbound Files
16.7.2
Inbound Files
16.7.3
Transaction Time
16.7.4
General B2B Settings for Large Payloads
16.8
Configurations for Argus Safety
16.8.1
Configure Oracle B2B
16.8.2
Update for B2B Documents
16.8.3
Argus Console > Reporting Destination Code List
17
Configure OBIEE or BI Publisher
17.1
Prepare BI Publisher Server
17.2
Set Up BI Publisher for Argus Safety
17.2.1
Install and Configure East Asian Fonts (Optional)
17.2.2
Enable a Local Superuser
17.2.3
Create a Database Connection
17.2.4
Set Up Runtime BI Publisher Memory
17.2.5
Configure Oracle Fusion Middleware Security Model
17.3
Manage Users and Roles
17.3.1
Configure Users, Groups and Roles
17.3.1.1
Create a Group
17.3.1.2
Create a User
17.3.1.3
Create an Application Role
17.3.2
Create Application Policies and Set Up Folder Privileges (BI Publisher Standalone only)
17.3.2.1
Create Application Policies
17.3.2.2
Manage Folder Privileges
17.3.3
Create Application Policies and Set Up Folder Privileges (OBIEE and BI Integrated Installation only)
17.3.3.1
Create Application Policies
17.3.3.2
Manage Folder Privileges
17.4
Upload BI Publisher Reports
17.4.1
Flexible Aggregate Reports
17.4.2
PMDA R3 Paper Reports
17.5
Integrate Argus Safety with BI Publisher
17.5.1
Configure AG Service
17.5.2
Configure Web Service (Expedited Reports only)
17.5.3
Add AG Service user to BI Publisher (Expedited Reports only)
17.5.4
Update SSO Exclusion List
17.6
Argus Console—BIP Common Settings
17.6.1
Configure BIP Reporting Admin User
17.6.2
Enable BIP Aggregate Reports and Configure Persistence Data (Flexible Aggregate Reporting only)
17.6.3
Configure Code Lists
17.6.3.1
Flexible Aggregate Reporting Code Lists
17.6.3.2
PMDA R3 Paper Forms Code lists
17.7
Configure Flexible Aggregate Reporting Database
17.7.1
Execute Argus_BIP_Enable
17.7.2
Database Jobs
17.7.2.1
Report Output Pusher
17.7.2.2
Persist Data Cleaner
17.8
Upgrade BIP Reports from 8.1.1 to 8.1.2
18
Install Argus Unblinding
18.1
Prerequisites
18.2
Install Argus Unblinding Utility
19
Configure Web Service Interfaces
19.1
Prerequisites
19.2
Install Web Service Interfaces
19.3
Reset IIS
19.4
Argus Web Service Interface
19.4.1
Argus Web Service Interface Framework
19.5
Edit .config Files
19.5.1
Edit the .config file for Outbound Interfaces
19.5.2
Edit the .config file for Inbound Interface
19.6
Safety Message
19.7
MedDRA Interface
19.7.1
MedDRA Configuration
19.7.1.1
Enable MedDRA Integration through Argus Console
19.7.1.2
Edit the ArgusWeb/ASP/web.config file
19.7.1.3
Edit the Argus.NET/web.config file
19.7.2
MedDRA Encoding Flow
19.7.3
Examples of MedDRA Encoding Safety Message
19.7.3.1
Request (V 2.0)
19.7.3.2
Response(V2.0)
19.7.3.3
Request (V 1.1)
19.7.3.4
Response (V 1.1)
19.7.3.5
Request (V 1.0)
19.7.3.6
Response (V 1.0)
19.7.4
MedDRA Interface XML Schema
19.7.4.1
MEDDRA_Request
19.7.4.2
MEDDRA_Response
19.8
Product Study License Interface
19.9
WHO Drug Coding Interface
19.9.1
Configuration
19.9.2
Drug Dictionary Coding Flow
19.9.3
Example of WHO Drug Coding Safety Message
19.9.3.1
Request
19.9.3.2
Response
19.9.4
WHO Drug Coding: XML Schema
19.9.4.1
Request: WHODrug_Request
19.9.4.2
Response: WHODrug_Response
19.10
Lot Number Interface
19.10.1
Configuration
19.10.2
Lot Validation Flow
19.10.3
Example of Lot Number Safety Message
19.10.3.1
Request
19.10.3.2
Response
19.10.4
Lot Number: XML Schema
19.10.4.1
Request: Lot_Request
19.10.4.2
Response: Lot_Response
19.10.5
Transformation
19.11
Worklist Intake
19.11.1
Configuration
19.11.2
Worklist Intake Flow
19.11.3
Example of Worklist Intake Safety Message
19.12
Literature Intake
19.12.1
Configuration
19.12.1.1
Metadata Configuration
19.12.2
Literature Intake Flow
19.13
Extended E2B Interface
20
Configure Argus Centralized Coding
20.1
setup_centralized_coding_interface_schema.bat
20.2
dms_migration.bat
20.2.1
Single Enterprise Migration in One Execution
20.2.2
All Enterprise Migration in One Execution
Part V Secure Argus Safety
21
Argus Password Management—Cryptography Tool
21.1
Install or Upgrade to Argus Safety 8.1.2
21.1.1
Generate New Cryptography Key
21.1.2
Argus Safety 8.1.2 Database
21.1.3
Argus Safety 8.1.2 Application Servers
21.2
Reset Password or Change the Cryptography Key
21.2.1
Reset the ARGUSUSER Password
21.2.2
Edit Keys
21.2.3
Re-encrypt Common User Passwords
21.2.4
Generate Encrypted String
21.2.5
Reset Administrator and System Application User Password
21.2.6
Reset the Environment if ArgusSecureKey.ini is Lost
A
Configure BI Publisher Security Model
A.1
Create Custom Roles and Assign Data Sources
A.2
Create Users and Assign Roles
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