Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Finding Information and Patches on My Oracle Support
• Finding Oracle Documentation
• Related Documents
• Conventions

1 Introduction

• 1.1 Overview of 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 7.0.3
  • 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
• 2.8 Logging Out

3 Creating Queries by Example

• 3.1 Overview of the Query by Example Tool
  • 3.1.1 About the Tabs on the QUERY BY EXAMPLE Page
  • 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 Reviewing the Input Fields on Each QBE Tab
  • 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 Associating a Report Group with a QBE
  • 3.6.6 Executing a Saved QBE
  • 3.6.7 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 Custom Filter
  • 4.3.2 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 Associating a Report Group with a Value Set
  • 4.5.7 Executing a Value Set
  • 4.5.8 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

• 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 Associating a Report Group with an Advanced Condition
  • 5.3.7 Executing an Advanced Condition
  • 5.3.8 Executing a Saved Advanced Condition on the Active Case Series

6 Working with Libraries

• 6.1 Viewing Save Queries in the Query Library
  • 6.1.1 Associating a Query in the Query Library
  • 6.1.2 Deleting a Query from the Query Library
  • 6.1.3 Disassociating a Report in the Query Library
• 6.2 Viewing All Reports Associated with a Query or Case Series
  • 6.2.1 Modifying a Query or Case Series in the Associated Reports Library
  • 6.2.2 Disassociating a Report in the Associated Reports Library

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
  • 7.2.9 Associating a Report Group with a 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 Before Freezing the Data in a Case Series
    • 7.5.1.1 Access Rights
    • 7.5.1.2 Working with Frozen Case Series
    • 7.5.1.3 Reports and a Frozen Case Series
    • 7.5.1.4 List Maintenance Items and Derivation Rules in a Frozen Case Series
  • 7.5.2 Freezing a Case Series
    • 7.5.2.1 Recognizing a Frozen Case Series
    • 7.5.2.2 Freezing and Saving Case Series
  • 7.5.3 Unfreezing Case Series Data
• 7.6 Using the Link to Argus Safety Medical Review

8 Generating and Scheduling Standard Reports

• 8.1 About Standard Reports
  • 8.1.1 Case Series, ETL, and Association
  • 8.1.2 Browser Configuration
• 8.2 Working in the STANDARD REPORTS Page
• 8.3 Generating Standard Reports
• 8.4 Scheduling and Associating Reports Against a Query or Case Series
  • 8.4.1 Working in the Scheduled Reports Group Dialog Box
    • 8.4.1.1 Viewing the Reports in a Group
    • 8.4.1.2 Viewing, Sorting, and Searching the Report Groups
    • 8.4.1.3 Using the Command Buttons
  • 8.4.2 Associating a Report Group
• 8.5 Creating and Scheduling a New Report Group
  • 8.5.1 Working in the Reports Scheduling Dialog Box
    • 8.5.1.1 Entering the Report Name and Description
    • 8.5.1.2 Setting Up the Schedule
    • 8.5.1.3 Setting Up to Run the Reports Now
    • 8.5.1.4 Defining E-Mail Information
    • 8.5.1.5 Browsing and Sorting the List of Available Reports
    • 8.5.1.6 Selecting and Adding Reports to the Group
    • 8.5.1.7 Selecting a Report Format
    • 8.5.1.8 Saving the Schedule
• 8.6 Listing of the Standard Reports
  • 8.6.1 General Reports

9 Generating and Scheduling Standard Reports - BIP

• 9.1 About Standard Reports
  • 9.1.1 Case Series, ETL, and Association
  • 9.1.2 Browser Configuration
  • 9.1.3 Report Cover Page
    • 9.1.3.1 Page Header
    • 9.1.3.2 Page Contents
    • 9.1.3.3 Page Footer
• 9.2 Working in the Reports Page
• 9.3 Generating Reports
• 9.4 Scheduling and Associating Reports Against a Query or Case Series

10 Creating Custom Reports - BIP

• 10.1 Creating a New Report
• 10.2 Editing Reports
• 10.3 Changing the Report Layout

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
• 11.8 Standard Reports

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
  • 12.5.7 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

Glossary