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Oracle® Argus Insight BOXI User's Guide,
Release 6.0
E18287-01
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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
Case Processing Reports
6.2.3
Compliance Reports
6.2.4
Configuration Reports
6.2.5
General Reports
6.2.6
Management Reports
6.2.7
Pharmacovigilance Reports
7
Custom Reports
7.1
Creating Custom Reports
7.1.1
Using Report Writer
7.1.1.1
Creating a New Report
7.1.1.1.1
Using Case Series Criteria and Case Series Name in new Report
7.1.1.1.2
Using Case Series Criteria and Case Series Name with Other Objects
7.1.1.2
Editing Reports
7.1.1.2.1
Filtering Data
7.1.1.2.2
Sorting Data
7.1.1.2.3
Summarizing Data
7.1.1.2.4
Formatting Data in Cells
7.1.1.3
Changing the Report Layout
7.1.1.3.1
Creating a Table
7.1.1.3.2
Creating a Bar Chart
7.1.1.3.3
Creating a Line Chart
7.1.1.3.4
Creating an Area Chart
7.1.1.3.5
Creating a Pie Chart
7.1.1.3.6
Creating a Radar Chart
7.1.1.4
Saving and Accessing Reports
7.1.1.4.1
Saving Reports
7.1.1.4.2
Accessing the Report Writer Library
7.1.1.5
Using SMQs in Report Writer
7.1.1.5.1
Using SMQs
7.1.1.6
Using Case Annotations
7.1.1.6.1
Using Case Annotations
7.1.2
Using AdHoc Reports
7.1.2.1
Using BO Infoview
8
Using Cubes
8.1
Using Cubes to Generate Custom Reports
8.1.1
Using Cubes
8.1.1.1
Working with Cubes
8.1.1.1.1
Filtering Data
8.1.1.1.2
Replacing Rows and Columns
8.1.1.1.3
Grouping Multiple Rows and Columns by a Dimension or Category
8.1.1.1.4
Creating Charts
8.1.1.1.5
Swapping Rows with Columns
8.1.1.1.6
Exporting the Cube Output to Specific Formats
8.1.1.1.7
Changing Measures
8.1.1.1.8
Modify/Delete
8.1.1.1.9
Setting Access Permissions
8.1.1.2
Cubes Available in Argus Insight
8.1.1.2.1
Compliance Cubes
8.1.1.2.2
Management Cubes
8.1.1.2.3
Pharmacovigilance Cubes
8.1.1.2.4
PV Clinical Cube
8.1.1.2.5
PV Detail Cube
8.1.1.2.6
PV General Cube
8.1.1.2.7
PV Interaction Cube
8.1.1.3
Creating Demand Cubes
8.1.1.4
Drill Through Cubes
8.1.1.5
Performing Drill Through Operations
8.1.1.6
Saving Cubes Views
8.1.1.7
Refreshing Cubes
8.1.1.7.1
Setting up Batch Generation through Task Manager:
8.1.1.7.2
Configuring the CIOMS and MedWatch Reports
9
Viewing Dashboard Indicator Reports
9.1
Dashboard Indicator Reports
Glossary