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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
1
Introduction
1.1
Generating 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 8.1.1
1.4.4
Copy Configuration Utility
2
Getting Started
2.1
About Login Accounts and Access
2.1.1
System Administrator Account
2.1.2
Single Sign-On Accounts
2.2
Logging In to the Argus Insight Application
2.3
Setting Your Personal Options
2.3.1
Changing the Default Home Page
2.3.2
Changing Your Preferences for Overwrite Confirmation
2.3.3
Viewing Group Memberships
2.4
Entering Dates in Argus Insight Date Fields
2.5
Viewing the Database Name and Argus Insight Release
2.6
Viewing the Online Help
2.7
Extending Argus Insight Features
3
Creating 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
Using the Type-Ahead Feature in Input Fields
3.2
Starting a New QBE
3.2.1
Entering Your Search Criteria and Executing the QBE
3.2.2
Reviewing the Results of Your QBE
3.2.3
Reviewing and Modifying the Criteria for an Executed QBE
3.2.4
Saving the QBE
3.3
Query By Example Page—Input Fields
3.3.1
General Tab
3.3.1.1
Selecting the Study Information
3.3.2
Patient Tab
3.3.2.1
Patient View
3.3.2.2
Parent View
3.3.2.3
Selecting a Lab Test
3.3.2.4
Using the MedDRA Browser
3.3.3
Products Tab
3.3.3.1
Using the Product Browser
3.3.3.2
Using the WHO Drug Browser
3.3.3.3
Using 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
Assigning Group-Level Permissions to a Saved QBE
3.5
Working with the Last Modified or Executed QBE
3.6
Working with Saved QBEs
3.6.1
Searching for a Saved QBE
3.6.2
Creating a New QBE
3.6.3
Modifying a Saved QBE
3.6.4
Deleting a Saved QBE
3.6.5
Executing a Saved QBE
3.6.6
Executing a Saved QBE on the Active Case Series
3.7
Using QBEs with Advanced Conditions
3.7.1
Converting a QBE to an Advanced Condition
3.7.2
Integrating a QBE with an Advanced Condition
4
Using Filters to Create Queries
4.1
About Filters
4.2
Using Predefined Filters
4.2.1
Selecting a Predefined Filter
4.2.2
Creating a Value Set for the Predefined Filter
4.2.3
Executing a Value Set
4.3
Creating Custom Filters
4.3.1
Creating a Value Set for a Custom Filter
4.4
Working with the Last Modified or Executed Value Set
4.5
Working with Saved Filters and Value Sets
4.5.1
Searching Saved Filters and Value Sets
4.5.2
Creating a New Filter
4.5.3
Creating a New Value Set
4.5.4
Modifying a Filter or Value Set
4.5.5
Deleting a Filter or Value Set
4.5.6
Executing a Value Set
4.5.7
Executing a Saved Value Set on the Active Case Series
4.6
Using Filters with Advanced Conditions
4.6.1
Converting a Value Set to an Advanced Condition
4.6.2
Integrating a Value Set with an Advanced Condition
5
Using Advanced Conditions to Create Queries on Insight Mart
5.1
Creating a New Advanced Condition
5.1.1
Returning to the Advanced Conditions Editor
5.1.2
Assigning a Category to an Advanced Condition
5.1.3
Using and Ordering Advanced Condition Operators
5.1.3.1
Advanced Condition Example
5.1.3.2
Sample SQL Generated
5.2
Working with the Last Modified or Saved Advanced Condition
5.3
Working with Saved Advanced Conditions
5.3.1
Searching Saved Advanced Conditions
5.3.2
Creating a New Advanced Condition
5.3.3
Modifying an Advanced Condition
5.3.4
Modifying the SQL of an Advanced Condition
5.3.5
Deleting an Advanced Condition
5.3.6
Executing an Advanced Condition
5.3.7
Executing a Saved Advanced Condition on the Active Case Series
6
Using Advanced Conditions to Create Point-in-Time Queries on Argus Mart
6.1
Creating a New Advanced Condition
6.1.1
Saving and Providing Point-in-Time Query Date
6.1.2
Returning to the Advanced Conditions Editor
6.1.3
Assigning a Category to an Advanced Condition
6.1.4
Using and Ordering Advanced Condition Operators
6.2
Working with the Last Modified or Saved Advanced Condition
6.3
Working with Saved Advanced Conditions
6.3.1
Searching Saved Advanced Conditions
6.3.2
Creating a New Advanced Condition
6.3.3
Modifying an Advanced Condition
6.3.4
Modifying the SQL of an Advanced Condition
6.3.5
Deleting an Advanced Condition
6.3.6
Executing an Advanced Condition
6.3.7
Executing a Saved Advanced Condition on the Active Case Series
7
Working with Case Series
7.1
Working with the Active Case Series
7.1.1
Viewing the Active Case Series
7.1.1.1
Active Case Series and Active Query Names
7.1.1.2
Sorting, Searching, and Navigating
7.1.2
Saving the Active Case Series
7.1.3
Viewing the Criteria that Generated the Active Case Series
7.1.4
Assigning Group-Level Access Permissions
7.1.5
Adding 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
Adding a Case to a Case Series
7.1.7
Deleting a Case from a Case Series
7.2
Working with Case Series Saved in the Library
7.2.1
Opening the CASE SERIES LIBRARY Page
7.2.2
Searching for a Saved Case Series in the Library
7.2.3
Making a Case Series Active
7.2.4
Modifying a Case Series
7.2.5
Merging Case Series
7.2.6
Importing a Case Series from an External Source
7.2.7
Deleting a Case Series from the Library
7.2.8
Viewing the Query Criteria that Generated the Case Series
7.3
Sharing Case Series with Argus Safety Web
7.4
Exporting a Case Series to Microsoft Excel
7.5
Freezing and Unfreezing Case Series Data
7.5.1
Freezing a Case Series
7.5.1.1
Recognizing a Frozen Case Series
7.5.1.2
Freezing and Saving Case Series
7.5.2
Unfreezing Case Series Data
7.6
Using the Link to Argus Safety Medical Review
8
Generating and Scheduling 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
Working in the Reports Page
8.3
Generating Reports
8.4
Scheduling and Associating Reports Against a Query or Case Series
9
Creating Custom Reports - BIP
9.1
Creating a New Report
9.2
Editing Reports
9.3
Changing the Report Layout
10
Generating OBIEE Answers and Working on Aggregate Analysis - Sample Dashboard
10.1
Argus Insight Catalog
10.2
About OBIEE Aggregate Analysis - Sample Dashboard
10.3
Working on BI Answers
10.3.1
Adding filters in Analysis
11
Working 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
Using Separate URLs to Access the Applications
11.3.1.2
Opening 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
Adding a New Enterprise
11.4.2.3
Copying an Enterprise
11.4.3
Global User Management Portlet
11.5
Power Queries and Case Series
11.5.1
Importing a Case Series
11.5.2
Modifying a Case Series
11.5.3
Deleting a Case Series
11.5.4
Exporting a Case Series
11.6
Common Profile Switches
11.7
ETL Scheduler
12
Using the Administration Tools
12.1
Support for Multibyte Characters
12.2
Using Schema Creation Tool
12.3
Opening the ADMINISTRATION TOOLS Page
12.4
Configuring Personal Options
12.5
Configuring Lists Maintenance
12.5.1
Configuring the Argus Insight Application Profile Switches
12.5.1.1
Accessing and Modifying the Profile Switches
12.5.1.2
Adding a New Profile Switch
12.5.1.3
Listing of the Common Profile Switches
12.5.2
Configuring European Union Countries
12.5.2.1
Adding a Country to the European Union List
12.5.2.2
Deleting a Country from the European Union List
12.5.3
Mapping Case Workflow States
12.5.4
Configuring Categories
12.5.5
Configuring Duration Value Bands
12.5.6
Configuring Derivation Functions
12.5.6.1
Opening 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
Configuring Case Series Modification Justification
12.5.8
Configuring Case Series Un-freezing Justification
12.5.9
Configuring Holiday Schedule Management
12.5.10
Configuring Product Designated Medical Event Configurations
12.5.11
Configuring Measurable Suppliers
12.5.12
Configuring Non-Core Sites
12.5.13
Configuring Acceptable Delay Justifications
12.6
Running 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
Scheduling the ETL
12.6.4
Monitoring the Progress of the ETL
12.7
Securing User Accounts, Groups, and Access Rights
12.7.1
Creating New User Groups
12.7.2
Copying Groups
12.7.3
Modifying Existing Groups
12.7.4
Deleting Existing Groups
12.7.5
Modifying User Accounts
12.8
Viewing the Audit Log
A
Appendix: Argus Insight Case Tables
Glossary
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