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Contents
Title and Copyright Information
Preface
Intended Audience
Where to Find More Information
Documentation Accessibility
1
Introduction
1.1
Introduction
1.1.1
Argus Safety Configuration Process Overview
1.1.2
Usage Conventions
1.1.3
Getting Started
1.1.4
Argus Console Architecture
1.1.4.1
Required Fields
1.1.4.2
Standard Buttons
1.1.4.3
Standard Icons
1.1.5
Administrator Login
1.1.5.1
Logging In as an Administrator:
1.1.5.2
Changing the Administrator's Password
1.1.5.3
Logging out
1.1.5.4
Accessing the Home Page
1.1.5.5
Launching Online Help
1.1.5.6
View the Error Log
1.1.5.7
Understanding Argus Console GUI
2
Access Management
2.1
Access Management
2.1.1
Configuring User Sites
2.1.1.1
Field Descriptions
2.1.1.2
Adding User Sites
2.1.1.2.1
About Filtering Criterion
2.1.2
Configuring Groups
2.1.2.1
Field Descriptions
2.1.2.2
Adding User Groups
2.1.2.2.1
Groups Included with the Factory Data
2.1.2.2.2
About Filtering Criterion
2.1.2.3
Printing a User Group
2.1.2.3.1
Group Configuration Print Out
2.1.2.3.2
About Filtering Criterion
2.1.3
Configuring Users
2.1.3.1
Field Descriptions
2.1.3.2
Printing Users
2.1.4
User Configuration - Roles
3
Business Configuration
3.1
About Business Configuration
3.1.1
Editable and Non-editable Business Configuration Sections
3.1.1.1
Type Ahead Fields
3.1.1.2
Additional Comments Fields
3.1.2
Configuring Product Family
3.1.2.1
Field Descriptions
3.1.2.2
Adding Product Families
3.1.2.2.1
About Filtering Criterion
3.1.2.3
Creating Data Sheets
3.1.2.4
Field Descriptions
3.1.3
Configuring Products
3.1.3.1
Field Descriptions
3.1.3.2
Adding Products
3.1.3.2.1
About Filtering Criterion
3.1.4
Configuring Licenses
3.1.4.1
Field Descriptions
3.1.4.2
Adding Product Licenses
3.1.4.3
Using the Product Browser
3.1.5
Configuring Clinical Studies
3.1.5.1
Field Descriptions
3.1.5.2
Adding Clinical Study Configurations
3.1.5.2.1
About Filtering Criterion
3.1.5.3
Adding WHO Drug Details
3.1.5.4
Adding Product Details
3.1.5.5
Configuring Auto Encoding
3.1.5.6
MedDRA Recoding
3.1.5.6.1
Recode MedDRA terms at the Enterprise level
3.1.5.7
Configuring Study Reporting
3.1.6
Configuring Expedited Report Rules
3.1.6.1
Field Descriptions
3.1.6.2
Expedited Reporting Rules Algorithm
3.1.6.2.1
Suppression of Duplicate Reports
3.1.6.2.2
Blinded/Forced Distribution
3.1.6.3
Adding Expedited Report Rules
3.1.6.3.1
About the Filtering Criterion
3.1.7
Configure Regulatory Reporting Rules
4
System Configuration
4.1
System Configuration Overview
4.1.1
Configuring Case Priority
4.1.1.1
Field Descriptions
4.1.2
Configuring Field Validations
4.1.2.1
Field Descriptions
4.1.2.2
Modifying Field Validations
4.1.3
Configuring LAM System Numbering
4.1.3.1
Field Descriptions
4.1.4
Configuring System Management - Common Profile Switches
4.1.4.1
Configuring Advanced Conditions
4.1.4.1.1
Field Descriptions
4.1.4.2
Configuring Case Form (System Management)
4.1.4.2.1
Coding Web Service
4.1.4.2.2
Auto Encoding, Dictionary and Central Encoding
4.1.4.2.3
Automation
4.1.4.2.4
Templates
4.1.4.2.5
Creating a Template in Another Language
4.1.4.2.6
Copying a Template to Another Language
4.1.4.2.7
Deleting Templates
4.1.4.2.8
Duration Calculations
4.1.4.2.9
Documentum Common Login
4.1.4.2.10
Custom Routines
4.1.4.2.11
Table Config Button
4.1.4.2.12
Modify Data Lock Point
4.1.4.3
SMTP Configuration
4.1.4.4
Configuring Case Processing
4.1.4.4.1
Field Descriptions
4.1.4.5
Configuring Database
4.1.4.5.1
Field Descriptions
4.1.4.6
Configuring Assessments
4.1.4.6.1
Field Descriptions
4.1.4.7
Configuring Auto Archiving
4.1.4.7.1
Field Descriptions
4.1.4.8
Configuring Case Numbering
4.1.4.8.1
Field Descriptions
4.1.4.9
Configuring Lot Number
4.1.4.9.1
The Custom Node
4.1.4.10
Configuring the Dictionary Browser
4.1.4.10.1
Field Descriptions
4.1.4.10.2
Dictionaries
4.1.4.11
Configuring Group Data Access
4.1.4.11.1
Field Descriptions
4.1.4.12
Configuring WHO Drug
4.1.4.13
Configuring Performance
4.1.4.13.1
Field Descriptions
4.1.4.14
Configuring Documentum
4.1.4.14.1
Field Descriptions
4.1.4.15
Local Labeling
4.1.4.15.1
Configuring Local Labeling
4.1.4.15.2
Field Descriptions
4.1.4.15.3
Configuring LAM
4.1.4.15.4
Field Label Updates
4.1.4.15.5
Field Validation Updates
4.1.4.16
Network Settings
4.1.4.17
User Interface
4.1.4.17.1
Configuring User Interface
4.1.4.18
Configuring Reporting
4.1.4.18.1
Field Descriptions
4.1.4.18.2
Configuring E2B
4.1.4.18.3
Field Descriptions
4.1.4.18.4
Configuring eMDR
4.1.4.18.5
Configuring eVAERS
4.1.4.18.6
Expedited Reports Configuration
4.1.4.18.7
BIP Reporting
4.1.4.18.8
Expedited BfArM Reports Configuration
4.1.4.18.9
Expedited Canada Reports Configuration
4.1.4.18.10
Expedited CIOMS Reports
4.1.4.18.11
Expedited MedWatch Reports Configuration
4.1.4.18.12
Periodic Reports Configuration
4.1.4.18.13
Scheduling Reports Configuration
4.1.4.19
Configuring Security
4.1.4.19.1
Configuring
Cryptography within Common Profile > Security
4.1.4.20
Configuring Single Sign-on
4.1.4.21
Error Messages
4.1.4.22
Configuring SMTP
4.1.4.22.1
Field Descriptions
4.1.4.23
Configuring Workflow Items
4.1.4.23.1
Field Descriptions
4.1.5
Configuring Workflow
4.1.5.1
Worklist Updates
4.1.5.2
Configuring Case Workflow
4.1.5.2.1
Configuring
Workflow States
4.1.5.2.2
Configuring
Workflow Rules
4.1.5.3
Worklist Intake
4.1.5.3.1
Pending Dialog
4.1.5.3.2
Worklist Intake View
4.1.5.3.3
Worklist
4.1.5.3.4
Rejected Cases
4.1.5.3.5
User Site Updates and Access Management
4.1.6
Configuring System Numbering
4.1.6.1
Field Descriptions
4.1.7
Configuring Field Properties
4.1.7.1
Field Descriptions
4.1.8
Adding User Defined Fields
4.1.9
Configuring User Defined Fields
4.1.10
Configure Local Data Entry
4.1.10.1
About Local Fields
4.1.10.2
Access Local Case Data Lock Functionality
4.1.10.3
Process an Outlier
4.1.10.4
Activate Local Locking in Argus Safety
4.1.10.4.1
Enter Local Reports Configuration Seed Data
4.1.10.4.2
Enter Local Users Seed Data
4.1.10.4.3
Enter Local Fields Seed Data
4.1.10.5
Activate Local Reporting in Argus Safety
4.1.11
Enabled Modules
4.1.12
Interchange Mapping
5
Code List Configuration
5.1
Configuring Code Lists > Argus
5.1.1
Configuring Autosignals
5.1.1.1
Field Descriptions
5.1.2
Configuring Batch Reports
5.1.2.1
Field Descriptions
5.1.3
Configuring Letters
5.1.3.1
Field Descriptions
5.1.3.1.1
Letter Placeholder for the IND Cover Letter
5.1.4
Configuring Justifications
5.1.4.1
Field Descriptions
5.1.5
Configuring Electronic Transmission
5.1.5.1
Field Descriptions
5.1.6
Configuring Event Groups
5.1.6.1
Terms tab
5.1.6.2
Event Groups tab
5.1.6.3
SMQ tab
5.1.7
Configuring Literary Citations
5.1.7.1
Field Descriptions
5.1.8
Configuring Message Type
5.1.8.1
Field Descriptions
5.1.9
Configuring Reporting Destination
5.1.9.1
Agency Information
5.1.9.2
Local Company Contact
5.1.9.3
Configuring EDI
5.1.9.4
Configuring the Base Directory Path
5.1.9.5
SMTP
5.1.10
Configuring Routes of Administration
5.1.10.1
Field Descriptions
5.1.11
Configuring Study Center
5.1.11.1
Field Descriptions
5.1.12
Configuring Holiday Calendar
5.1.12.1
Field Descriptions
5.1.13
Other Code List Items
5.1.13.1
Formulation Factory Data
5.2
Configuring Code Lists >
Flexible Data Re-Categorization
5.2.1
Flexible Code Lists
5.2.2
Flexible Re-Categorization
6
Accessing Tools
6.1
Accessing Tools
6.1.1
Report Features
6.1.2
Viewing the ISCR Length Check Report
7
Using Advanced Conditions
7.1
Using Advanced Conditions
7.1.1
Features within Advanced Conditions
7.1.2
Using Advanced Conditions
7.1.3
Creating Advanced Conditions
7.1.4
Creating a Query Set of Advanced Conditions
7.1.4.1
New Action Type Fields and Field Description
7.1.5
Rename Query Sets
7.1.6
Use the Advanced Conditions from the Case Selection Dialog Box
7.1.7
Use the Advanced Conditions Library
7.1.8
Case Series (former Hit List) Tab
8
Data Privacy
8.1
Personally Identifiable Information
8.1.1
Personally Identifiable Information and Application Behavior
9
Best Practices
9.1
Configuring Argus Safety for ICSR Reports (HL7)
9.1.1
Configuring Reporting Destination for HL7 ICSR Reports
9.1.2
Customizing Profiles
9.1.3
Configuring ICSR Validation using the New Framework
9.1.4
Configuring Codelists
9.1.4.1
eMDR Specific Codelist Updates
9.1.4.2
eVAERS Specific Codelist Updates
9.1.5
PMDA E2B (R3) Flex Codelist
9.1.6
Business Configuration Updates
9.1.6.1
Setting up the Application Type in Business Configuration -> Products and Licenses (eVAERS specific)
9.1.6.2
Configuring PMDA Specific License Parameters
9.1.6.3
Configuring PMDA E2B (R3) Specific Study Parameter
9.1.7
System Configuration Updates
9.1.7.1
PMDA E2B (R3) Specific Switches
9.1.8
Optional Upgrade Scripts for Data Migration to New Fields
9.1.8.1
eVAERS specific
9.1.8.2
eMDR Specific
9.2
Attachments in HL7 Reports
9.3
Creating and Managing Amendments for eVAERS and E2B (R3) report
9.4
Null Flavor Handling in HL7 Reports
9.5
Best Practices in a Multi-Tenant Environment
9.5.1
Single Sign-on
9.5.1.1
Accessing Argus Safety Directly via URL
9.5.2
Global Homepage and Portlets
9.5.2.1
Global Worklists Columns
9.5.2.2
Global User Management
9.5.2.3
Global Enterprises
9.5.2.4
User-Enterprise Association
9.5.2.5
New User Creation/Association
9.5.2.6
Synchronizable User Attributes
9.5.2.7
Inactivating an Enterprise
9.5.3
Add a New Enterprise
9.5.4
New Enterprise Setup
9.5.5
Data Segregation
9.5.5.1
Data Segregation by Module
9.5.5.2
Data Segregation by Enterprise
9.5.5.2.1
Maintaining Consistency Across Enterprises
9.5.5.3
Data Segregation impact on system-level configuration items
9.5.6
Data Shared Across Enterprises
9.5.7
Applications Access
9.5.8
Pre-upgrade Considerations for Existing Databases
9.5.9
Post-upgrade Considerations for Existing Databases
9.5.10
Documentum Migration
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