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Oracle® Argus Insight Cognos Administrator's Guide,
Release 6.0
E18252-01
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Contents
Title and Copyright Information
Preface
Audience
Documentation Accessibility
Conventions
1
Introduction
1.1
Argus Insight Overview
1.1.1
Argus Insight Overview
1.1.1.1
Argus Insight Components
1.1.1.2
Argus Insight Process Flow
2
Upgradability and Compatibility
2.1
About Upgradability and Compatibility
2.1.1
Upgrade Path
2.1.2
Product Compatibility
2.1.3
Copy Configuration
3
Getting Started
3.1
Using Argus Insight
3.1.1
Getting Started
3.1.1.1
Single Sign on
3.1.1.2
Logging On
3.1.1.3
Changing the Password
3.1.1.4
Changing the Default Home Page
3.1.1.5
Configuring the Argus Insight Application
3.1.1.6
Entering Dates in Various Argus Insight Fields
3.1.1.7
Getting Help
3.1.1.8
Logging Out
4
Creating Queries
4.1
Creating Queries
4.1.1
QBE
4.1.1.1
Creating a New QBE
4.1.1.2
Assign group-level permissions on the saved QBE
4.1.1.2.1
General Page
4.1.1.2.2
Selecting the Study Number
4.1.1.2.3
Patient Page
4.1.1.2.4
Selecting a Lab Test
4.1.1.2.5
Using the MedDRA Browser
4.1.1.2.6
Products Page
4.1.1.2.7
Using the Product Browser
4.1.1.2.8
Using the WHO Drug Browser
4.1.1.2.9
Using the Study Drug Lookup
4.1.1.2.10
Events Page
4.1.1.2.11
Analysis Page
4.1.1.2.12
Activities Page
4.1.1.2.13
Additional Info Page
4.1.1.3
Working with the Last Modified or Executed QBE
4.1.1.4
Working with Saved QBEs
4.1.1.4.1
Searching for a Saved QBE
4.1.1.4.2
Creating a New QBE
4.1.1.4.3
Modifying a Saved QBE
4.1.1.4.4
Deleting a Saved QBE
4.1.1.4.5
Associating a QBE with a Report
4.1.1.4.6
Executing a Saved QBE
4.1.1.4.7
Executing a Saved QBE on the Active Case Series
4.1.1.5
Using QBEs with Advanced Conditions
4.1.1.5.1
Converting a QBE to an Advanced Condition
4.1.1.5.2
Integrating a QBE with an Advanced Condition
4.1.2
Filters
4.1.2.1
Using Predefined Filters
4.1.2.1.1
Selecting a Predefined Filter
4.1.2.1.2
Create a Value Set
4.1.2.1.3
Executing a Value Set
4.1.2.2
Creating Custom Filters
4.1.2.2.1
Creating a Custom Filter
4.1.2.2.2
Creating a Value Set for a Custom Filter
4.1.2.3
Working with the Last Modified or Executed Value Set
4.1.2.4
Working with Saved Filters and Value Sets
4.1.2.4.1
Searching Saved Filters and Value Sets
4.1.2.4.2
Creating a New Filter
4.1.2.4.3
Creating a New Value Set
4.1.2.4.4
Modifying a Filter or Value Set
4.1.2.4.5
Deleting a Filter or Value Set
4.1.2.4.6
Associating a Value Set with a Report
4.1.2.4.7
Executing a Value Set
4.1.2.4.8
Executing a Saved Value Set on the Active Case Series
4.1.2.5
Using Filters with Advanced Conditions
4.1.2.5.1
Converting a Value Set to an Advanced Condition
4.1.2.5.2
Integrating a Value Set with an Advanced Condition
4.1.3
Advanced Conditions
4.1.3.1
Creating a New Advanced Condition
4.1.3.1.1
Starting a New Advanced Condition
4.1.3.1.2
Returning the to Advanced Condition Editor
4.1.3.1.3
Assigning a Category to an Advanced Condition
4.1.3.1.4
Creating an Advanced Condition
4.1.3.2
Working with the Last Modified or Saved Advanced Condition
4.1.3.3
Working with Saved Advanced Conditions
4.1.3.3.1
Searching Saved Advanced Conditions
4.1.3.3.2
Creating a New Advanced Condition
4.1.3.3.3
Modifying an Advanced Condition
4.1.3.3.4
Modifying the SQL of an Advanced Condition
4.1.3.3.5
Deleting an Advanced Condition
4.1.3.3.6
Associating an Advanced Condition with a Report
4.1.3.3.7
Executing an Advanced Condition
4.1.3.3.8
Executing a Saved Advanced Condition on the Active Case Series
4.1.4
Library
4.1.4.1
Associated Reports Library
4.1.4.1.1
Modifying a Query in the Associated Reports Library
4.1.4.1.2
Deleting a Query in the Associated Reports Library
4.1.4.1.3
Disassociating a Report in the Associated Reports Library
4.1.4.2
Query Library
4.1.4.2.1
Associating a Query in the Query Library
4.1.4.2.2
Deleting a Query in the Query Library
4.1.4.2.3
Disassociating a Report in the Query Library
5
Working with Case Series
5.1
Working with Case Series
5.1.1
General Usage Information
5.1.1.1
Case Series Hyperlink to Medical Review
5.1.1.2
Freezing Case Series Data
5.1.1.2.1
Business Context
5.1.1.2.2
Feature Details
5.1.2
Working with the Last Generated Case Series
5.1.2.1
Saving the Case Series
5.1.2.2
Viewing Case Series Generation Criteria within the Query Interface
5.1.2.3
Viewing the Case Series Generation Criteria in a Single Page
5.1.2.4
Modifying the Case Series
5.1.2.5
Deleting a Case from a Case Series
5.1.3
Working with Saved Case Series
5.1.3.1
Searching for a Saved Case Series
5.1.3.2
Making a Case Series Active
5.1.3.3
Modifying a Case Series
5.1.3.4
Merging Case Series
5.1.3.5
Importing a Case Series from an External Source
5.1.3.6
Deleting a Case Series
5.1.3.7
Viewing the Details of the Query that Generated the Case Series
5.1.4
Sharing Case Series with Argus Safety Web
5.1.5
Exporting Case Series to Excel
6
Generating Standard Reports
6.1
General Report Usage Information
6.1.1
Using Reports
6.1.1.1
Executing Reports
6.1.1.2
Event-Level Reporting
6.1.1.2.1
Feature Details
6.1.1.3
Report Scheduling
6.1.1.3.1
Scheduling Multiple Reports Against a Single Query
6.1.1.3.2
Scheduling a Report without a Query
6.2
Standard Reports
6.2.1
Reports - Cover Page
6.2.2
Compliance Reports
6.2.3
Configuration Reports
6.2.4
General Reports
6.2.5
Management Reports
6.2.6
Pharmacovigilance Reports
7
Creating Custom Reports
7.1
Creating Custom Reports
7.1.1
General Report Writer Information
7.1.2
Creating a New Report
7.1.2.1
Using Case Series Criteria and Case Series Name in new Report.
7.1.2.2
Using Case Series Criteria and Name with Other Objects
7.1.3
Editing Reports
7.1.3.1
Filtering Data
7.1.3.2
Sorting Data
7.1.3.3
Summarizing Data
7.1.3.4
Formatting Data in Cells
7.1.3.5
Performing Calculations
7.1.4
Changing the Report Layout
7.1.4.1
Creating a Chart
7.1.4.2
Grouping by Row Headings
7.1.4.3
To Ungroup a Report
7.1.4.4
Creating Crosstab Reports
7.1.4.4.1
Summarize the Sections in the Report
7.1.4.4.2
Convert to a Crosstab Report
7.1.4.4.3
Creating Sections in the Report
7.1.4.4.4
Swapping Rows and Columns
7.1.4.5
Running the Report in Specific Formats
7.1.5
Saving and Accessing Saved Reports
7.1.5.1
Saving Reports
7.1.5.1.1
Saving a Report in a New Folder
7.1.5.2
Accessing Report Writer Library
7.1.6
Using SMQs in Report Writer
7.1.6.1
Using SMQs
7.1.7
Using Case Annotations
7.1.7.1
Using Case Annotations
8
Using Cubes
8.1
Using Cubes
8.1.1
Cubes Available in Argus Insight
8.1.1.1
Compliance Cubes
8.1.1.2
Submission Statistics
8.1.1.3
Management Cubes
8.1.1.4
Administration Statistics
8.1.1.5
Pharmacovigilance Cubes
8.1.1.6
Clinical Trial Analysis
8.1.1.7
Medical Analysis
8.1.1.8
Overdose-Pregnancy-Interaction
8.1.2
Working with Cubes
8.1.2.1
Executing a Cube
8.1.2.2
Performing Drill Operations
8.1.2.3
Filtering Data
8.1.2.4
Removing the Filter
8.1.2.5
Replacing Rows and Columns
8.1.2.6
Grouping Multiple Rows and Columns by a Dimension or Category
8.1.2.6.1
Obtaining a New Row Grouping
8.1.2.6.2
Obtaining a New Column Grouping
8.1.2.6.3
Removing a Dimension Row from a Cube
8.1.2.6.4
Removing a Dimension Column from a Cube
8.1.2.7
Creating Charts
8.1.2.8
Exporting the Cube Output to Specific Formats
8.1.2.9
Changing Measures
8.1.2.10
Modifying a Cube
8.1.2.11
Deleting a Cube
8.1.2.12
Setting Access Permissions
8.1.2.13
Creating Demand Cubes
8.1.2.14
Demand Cube Life Span
8.1.2.15
Saving Cubes Views
8.1.2.16
Viewing Saved Cubes
8.1.2.17
Refreshing Cubes
8.1.2.17.1
Setting up Batch Generation through Task Manager
9
Viewing Dashboard Indicator Reports
9.1
Dashboard Indicator Reports
10
Administration Tools
10.1
Administration Tools
10.1.1
General Usage Information
10.1.1.1
Multibyte Character Support
10.1.1.2
Support for Multiple LDAP Servers
10.1.1.2.1
Use Case 01: Authenticate User
10.1.1.3
Schema Creation
10.1.1.4
Configurable Excel Version for Cognos Reports
10.1.2
Using Administration Tools
10.1.2.1
Configuring Personal Options
10.1.2.2
Maintaining Argus Insight Lists
10.1.2.3
Configuring Profile Switches
10.1.2.4
Modifying the Value of a Profile Switch
10.1.2.5
Adding a New Profile Switch
10.1.2.6
Configuring EU Countries
10.1.2.7
Workflow Management
10.1.2.8
Configuring Categories
10.1.2.9
Configuring Duration Value Bands
10.1.2.10
Configuring Derivation Functions
10.1.2.10.1
Argus
Field
Derivation Rules
10.1.2.10.2
LM Table
10.1.2.10.3
Suppress
10.1.2.10.4
Value
10.1.2.10.5
Priority
10.1.2.10.6
SQL
10.1.2.11
Configuring Case Series Modification Justification
10.1.2.12
Configuring Case Series Un-freezing Justification
10.1.2.13
Cube-on-the-Fly Case Limit
10.1.2.14
Configuring Priority Drugs
10.1.3
Configuring User Groups and Accounts
10.1.3.1
Creating New Groups and Accounts
10.1.3.2
Copying Groups and Accounts
10.1.3.3
Modifying Existing Groups and Accounts
10.1.3.4
Deleting Existing Groups and Accounts
10.1.4
Scheduling the ETL
10.1.5
Configuring Dashboard Indicators
10.1.6
Viewing the Audit Log
Glossary
