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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Introduction
1.1
Generate Reports in Argus Insight
1.2
Argus Insight Components
1.3
Argus Insight Process Flow
1.4
Product Compatibility and Upgrade Options
1.4.1
Compatibility of Argus Insight with Argus Safety
1.4.2
Compatibility of Argus Insight with Reporting Tools
1.4.3
Upgrade Paths to Argus Insight 8.2
1.4.4
Copy Configuration Utility
2
Get Started
2.1
About Login Accounts and Access
2.1.1
System Administrator Account
2.1.2
Single Sign-On Accounts
2.2
Log-in to the Argus Insight Application
2.3
Set Up Your Personal Options
2.3.1
Change the Default Home Page
2.3.2
Change Your Preferences for Overwrite Confirmation
2.3.3
View Group Memberships
2.4
Enter Dates in Argus Insight Date Fields
2.5
View the Database Name and Argus Insight Release
2.6
View the Online Help
2.7
Extend Argus Insight Features
3
Create Queries by Example
3.1
Overview of the Query by Example Tool
3.1.1
QUERY BY EXAMPLE Page—Tab Description
3.1.2
Example of a QBE
3.1.3
Use the Type-Ahead Feature in Input Fields
3.2
Start a New QBE
3.2.1
Enter Your Search Criteria and Execute the QBE
3.2.2
Review the Results of Your QBE
3.2.3
Review and Modify the Criteria for an Executed QBE
3.2.4
Save the QBE
3.3
Query By Example Page—Input Fields
3.3.1
General Tab
3.3.1.1
Select the Study Information
3.3.2
Patient Tab
3.3.2.1
Patient View
3.3.2.2
Parent View
3.3.2.3
Select a Lab Test
3.3.2.4
Use the MedDRA Browser
3.3.3
Products Tab
3.3.3.1
Use the Product Browser
3.3.3.2
Use the WHO Drug Browser
3.3.3.3
Use the Study Drug Lookup
3.3.4
Events Tab
3.3.5
Analysis Tab
3.3.6
Activities Tab
3.3.7
Additional Info Tab
3.4
Assign Group-Level Permissions to a Saved QBE
3.5
Work with the Last Modified or Executed QBE
3.6
Work with Saved QBEs
3.6.1
Search for a Saved QBE
3.6.2
Create a New QBE
3.6.3
Modify a Saved QBE
3.6.4
Delete a Saved QBE
3.6.5
Execute a Saved QBE
3.6.6
Execute a Saved QBE on the Active Case Series
3.7
Use QBEs with Advanced Conditions
3.7.1
Convert a QBE to an Advanced Condition
3.7.2
Integrate a QBE with an Advanced Condition
4
Use Filters to Create Queries
4.1
About Filters
4.2
Use Predefined Filters
4.2.1
Select a Predefined Filter
4.2.2
Create a Value Set for the Predefined Filter
4.2.3
Execute a Value Set
4.3
Create Custom Filters
4.3.1
Create a Value Set for a Custom Filter
4.4
Work with the Last Modified or Executed Value Set
4.5
Work with Saved Filters and Value Sets
4.5.1
Search Saved Filters and Value Sets
4.5.2
Create a New Filter
4.5.3
Create a New Value Set
4.5.4
Modify a Filter or Value Set
4.5.5
Delete a Filter or Value Set
4.5.6
Execute a Value Set
4.5.7
Execute a Saved Value Set on the Active Case Series
4.6
Use Filters with Advanced Conditions
4.6.1
Convert a Value Set to an Advanced Condition
4.6.2
Integrate a Value Set with an Advanced Condition
5
Use Advanced Conditions to Create Queries on Insight Mart
5.1
Create a New Advanced Condition
5.1.1
Return to the Advanced Conditions Editor
5.1.2
Assign a Category to an Advanced Condition
5.1.3
Use and Order Advanced Condition Operators
5.1.3.1
Advanced Condition Example
5.1.3.2
Sample SQL Generated
5.2
Work with the Last Modified or Saved Advanced Condition
5.3
Work with Saved Advanced Conditions
5.3.1
Search Saved Advanced Conditions
5.3.2
Create a New Advanced Condition
5.3.3
Modify an Advanced Condition
5.3.4
Modify the SQL of an Advanced Condition
5.3.5
Delete an Advanced Condition
5.3.6
Execute an Advanced Condition
5.3.7
Execute a Saved Advanced Condition on the Active Case Series
6
Use Advanced Conditions to Create Point-in-Time Queries on Argus Mart
6.1
Create a New Advanced Condition
6.1.1
Save and Provide Point-in-Time Query Date
6.1.2
Return to the Advanced Conditions Editor
6.1.3
Assign a Category to an Advanced Condition
6.1.4
Use and Order Advanced Condition Operators
6.2
Work with the Last Modified or Saved Advanced Condition
6.3
Work with Saved Advanced Conditions
6.3.1
Search Saved Advanced Conditions
6.3.2
Create a New Advanced Condition
6.3.3
Modify an Advanced Condition
6.3.4
Modify the SQL of an Advanced Condition
6.3.5
Delete an Advanced Condition
6.3.6
Execute an Advanced Condition
6.3.7
Execute a Saved Advanced Condition on the Active Case Series
7
Work with Case Series
7.1
Work with the Active Case Series
7.1.1
View the Active Case Series
7.1.1.1
Active Case Series and Active Query Names
7.1.1.2
Sort, Search, and Navigate
7.1.2
Save the Active Case Series
7.1.3
View the Criteria that Generated the Active Case Series
7.1.4
Assign Group-Level Access Permissions
7.1.5
Add an Annotation to a Case
7.1.5.1
About Case Annotations
7.1.5.2
Annotations in the Active Case Series
7.1.5.3
Annotations in Advanced Conditions
7.1.6
Add a Case to a Case Series
7.1.7
Delete a Case from a Case Series
7.2
Work with Case Series Saved in the Library
7.2.1
Open the CASE SERIES LIBRARY Page
7.2.2
Search for a Saved Case Series in the Library
7.2.3
Make a Case Series Active
7.2.4
Modify a Case Series
7.2.5
Merge Case Series
7.2.6
Import a Case Series from an External Source
7.2.7
Delete a Case Series from the Library
7.2.8
View the Query Criteria that Generated the Case Series
7.3
Share Case Series with Argus Safety Web
7.4
Export a Case Series to Microsoft Excel
7.5
Freeze and Unfreeze Case Series Data
7.5.1
Freeze a Case Series
7.5.1.1
Recognize a Frozen Case Series
7.5.1.2
Freeze and Save Case Series
7.5.2
Unfreeze a Case Series Data
7.6
Use the Link to Argus Safety Medical Review
8
Generate and Schedule Standard Reports - BIP
8.1
About BIP Standard Reports
8.1.1
Case Series, ETL, and Association
8.1.2
Browser Configuration
8.1.3
Report Cover Page
8.1.3.1
Page Header
8.1.3.2
Page Contents
8.1.3.3
Page Footer
8.2
Work in the Reports Page
8.3
Generate Reports
8.4
Schedule and Associate Reports Against a Query or Case Series
9
Create Custom Reports - BIP
9.1
Create a New Report
9.2
Edit Reports
9.3
Change the Report Layout
10
Generate OBIEE Answers and Work on Aggregate Analysis—Sample Dashboard
10.1
Argus Insight Catalog
10.2
About OBIEE Aggregate Analysis—Sample Dashboard
10.3
Work on BI Answers
10.3.1
Add filters in Analysis
11
Work in a Multi-Tenant Environment
11.1
Assumptions and Constraints
11.2
Data Segregation
11.2.1
Module-Wise Impact
11.2.2
Enterprise Short Name in Argus Insight
11.3
Login and Navigation
11.3.1
Single Sign-On Accounts
11.3.1.1
Use Separate URLs to Access the Applications
11.3.1.2
Open Argus Insight from Other Applications
11.3.2
Enterprise Switching
11.3.3
Direct Access
11.4
Global Homepage
11.4.1
Application Access Portlet
11.4.2
Global Enterprise Management Portlet
11.4.2.1
Overview of the Global Enterprise Management Page Layout
11.4.2.2
Add a New Enterprise
11.4.2.3
Copy an Enterprise
11.4.3
Global User Management Portlet
11.5
Power Queries and Case Series
11.5.1
Import a Case Series
11.5.2
Modify a Case Series
11.5.3
Delete a Case Series
11.5.4
Export a Case Series
11.6
Common Profile Switches
11.7
ETL Scheduler
12
Use the Administration Tools
12.1
Support for Multibyte Characters
12.2
Use Schema Creation Tool
12.3
Open the ADMINISTRATION TOOLS Page
12.4
Configure Personal Options
12.5
Configure Lists Maintenance
12.5.1
Configure the Argus Insight Application Profile Switches
12.5.1.1
Access and Modify the Profile Switches
12.5.1.2
Add a New Profile Switch
12.5.1.3
List of the Common Profile Switches
12.5.2
Configure European Union Countries
12.5.2.1
Add a Country to the European Union List
12.5.2.2
Delete a Country from the European Union List
12.5.3
Map Case Workflow States
12.5.4
Configure Categories
12.5.5
Configure Duration Value Bands
12.5.6
Configure Derivation Functions
12.5.6.1
Open the Derivation Fields Dialog Box
12.5.6.2
Icons in the Derivation Fields Dialog Box
12.5.6.3
Field Mapping Derivation Rules
12.5.6.4
Fields and Check Boxes in the Derivation Fields Dialog Box
12.5.6.4.1
LM Table
12.5.6.4.2
Suppress
12.5.6.4.3
Value
12.5.6.4.4
Causality Rule
12.5.6.4.5
Report Type Rule
12.5.6.4.6
Age Group Role
12.5.6.4.7
Last Daily Dose Rule
12.5.6.4.8
Priority
12.5.6.4.9
SQL
12.5.7
Configure Case Series Modification Justification
12.5.8
Configure Case Series Un-freezing Justification
12.5.9
Configure Holiday Schedule Management
12.5.10
Configure Product Designated Medical Event Configurations
12.5.11
Configure Measurable Suppliers
12.5.12
Configure Non-Core Sites
12.5.13
Configure Acceptable Delay Justifications
12.6
Run the Extract, Transform, and Load Process
12.6.1
Data Integrity Checks Before ETL
12.6.2
Initial ETL Versus Incremental ETL
12.6.3
Schedule the ETL
12.6.4
Monitor the Progress of the ETL
12.7
Secure User Accounts, Groups, and Access Rights
12.7.1
Create New User Groups
12.7.2
Copy Groups
12.7.3
Modify Existing Groups
12.7.4
Delete Existing Groups
12.7.5
Modify User Accounts
12.8
View the Audit Log
A
Appendix: Argus Insight Case Tables
Glossary
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