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

• Overview of Generating Reports in Argus Insight
• Argus Insight Components
• Argus Insight Process Flow
• Product Compatibility and Upgrade Options
  • Compatibility of Argus Insight with Argus Safety
  • Upgrade Paths to Argus Insight 7.0.2
  • Copy Configuration Utility

2 Getting Started

• About Login Accounts and Access
  • System Administrator Account
  • Single Sign-On Accounts
• Logging In to the Argus Insight Application
• Setting Your Personal Options
  • Changing the Default Home Page
  • Changing Your Preferences for Overwrite Confirmation
  • Viewing Group Memberships
• Entering Dates in Argus Insight Date Fields
• Viewing the Database Name and Argus Insight Release
• Viewing the Online Help
• Logging Out

3 Creating Queries by Example

• Overview of the Query by Example Tool
  • About the Tabs on the QUERY BY EXAMPLE Page
  • Example of a QBE
  • Using the Type-Ahead Feature in Input Fields
• Starting a New QBE
  • Entering Your Search Criteria and Executing the QBE
  • Reviewing the Results of Your QBE
  • Reviewing and Modifying the Criteria for an Executed QBE
  • Saving the QBE
• Reviewing the Input Fields on Each QBE Tab
  • General Tab
    • Selecting the Study Information
  • Patient Tab
    • Patient View
    • Parent View
    • Selecting a Lab Test
    • Using the MedDRA Browser
  • Products Tab
    • Using the Product Browser
    • Using the WHO Drug Browser
    • Using the Study Drug Lookup
  • Events Tab
  • Analysis Tab
  • Activities Tab
  • Additional Info Tab
• Assigning Group-Level Permissions to a Saved QBE
• Working with the Last Modified or Executed QBE
• Working with Saved QBEs
  • Searching for a Saved QBE
  • Creating a New QBE
  • Modifying a Saved QBE
  • Deleting a Saved QBE
  • Associating a Report Group with a QBE
  • Executing a Saved QBE
  • Executing a Saved QBE on the Active Case Series
• Using QBEs with Advanced Conditions
  • Converting a QBE to an Advanced Condition
  • Integrating a QBE with an Advanced Condition

4 Using Filters to Create Queries

• About Filters
• Using Predefined Filters
  • Selecting a Predefined Filter
  • Creating a Value Set for the Predefined Filter
  • Executing a Value Set
• Creating Custom Filters
  • Creating a Custom Filter
  • Creating a Value Set for a Custom Filter
• Working with the Last Modified or Executed Value Set
• Working with Saved Filters and Value Sets
  • Searching Saved Filters and Value Sets
  • Creating a New Filter
  • Creating a New Value Set
  • Modifying a Filter or Value Set
  • Deleting a Filter or Value Set
  • Associating a Report Group with a Value Set
  • Executing a Value Set
  • Executing a Saved Value Set on the Active Case Series
• Using Filters with Advanced Conditions
  • Converting a Value Set to an Advanced Condition
  • Integrating a Value Set with an Advanced Condition

5 Using Advanced Conditions to Create Queries

• Creating a New Advanced Condition
  • Returning to the Advanced Conditions Editor
  • Assigning a Category to an Advanced Condition
  • Using and Ordering Advanced Condition Operators
    • Advanced Condition Example
    • Sample SQL Generated
• Working with the Last Modified or Saved Advanced Condition
• Working with Saved Advanced Conditions
  • Searching Saved Advanced Conditions
  • Creating a New Advanced Condition
  • Modifying an Advanced Condition
  • Modifying the SQL of an Advanced Condition
  • Deleting an Advanced Condition
  • Associating a Report Group with an Advanced Condition
  • Executing an Advanced Condition
  • Executing a Saved Advanced Condition on the Active Case Series

6 Working with Libraries

• Viewing Save Queries in the Query Library
  • Associating a Query in the Query Library
  • Deleting a Query from the Query Library
  • Disassociating a Report in the Query Library
• Viewing All Reports Associated with a Query or Case Series
  • Modifying a Query or Case Series in the Associated Reports Library
  • Disassociating a Report in the Associated Reports Library

7 Working with Case Series

• Working with the Active Case Series
  • Viewing the Active Case Series
    • Active Case Series and Active Query Names
    • Sorting, Searching, and Navigating
  • Saving the Active Case Series
  • Viewing the Criteria that Generated the Active Case Series
  • Assigning Group-Level Access Permissions
  • Adding an Annotation to a Case
    • About Case Annotations
    • Annotations in the Active Case Series
    • Annotations in Advanced Conditions
    • Annotations in Report Writer
  • Adding a Case to a Case Series
  • Deleting a Case from a Case Series
• Working with Case Series Saved in the Library
  • Opening the CASE SERIES LIBRARY Page
  • Searching for a Saved Case Series in the Library
  • Making a Case Series Active
  • Modifying a Case Series
  • Merging Case Series
  • Importing a Case Series from an External Source
  • Deleting a Case Series from the Library
  • Viewing the Query Criteria that Generated the Case Series
  • Associating a Report Group with a Case Series
• Sharing Case Series with Argus Safety Web
• Exporting a Case Series to Microsoft Excel
• Freezing and Unfreezing Case Series Data
  • Before Freezing the Data in a Case Series
    • Access Rights
    • Working with Frozen Case Series
    • Reports and a Frozen Case Series
    • List Maintenance Items and Derivation Rules in a Frozen Case Series
  • Freezing a Case Series
    • Recognizing a Frozen Case Series
    • Freezing and Saving Case Series
  • Unfreezing Case Series Data
• Using the Link to Argus Safety Medical Review

8 Generating and Scheduling Standard Reports - Cognos

• About Standard Reports
  • Case Series, ETL, and Association
  • Browser Configuration
  • Report Cover Page
    • Page Header
    • Page Contents
    • Page Footer
• Working in the STANDARD REPORTS Page
• Generating Standard Reports
• Producing an Event-Level Report
• Scheduling and Associating Reports Against a Query or Case Series
  • Working in the Scheduled Reports Group Dialog Box
    • Viewing the Reports in a Group
    • Viewing, Sorting, and Searching the Report Groups
    • Using the Command Buttons
  • Associating a Report Group
• Creating and Scheduling a New Report Group
  • Working in the Reports Scheduling Dialog Box
    • Entering the Report Name and Description
    • Setting Up the Schedule
    • Setting Up to Run the Reports Now
    • Defining E-Mail Information
    • Browsing and Sorting the List of Available Reports
    • Selecting and Adding Reports to the Group
    • Entering Required Pre-filters and Selecting a Report Format
    • Saving the Schedule
• Scheduling a Report without a Query
• Listing of the Standard Reports
  • Compliance Reports
  • Configuration Reports
  • General Reports
  • Management Reports
  • Pharmacovigilance Reports

9 Generating and Scheduling Standard Reports - BusinessObjects

• About Standard Reports
  • Case Series, ETL, and Association
  • Browser Configuration
  • Report Cover Page
    • Page Header
    • Page Contents
    • Page Footer
• Working in the STANDARD REPORTS Page
• Generating Standard Reports
• Producing an Event-Level Report
• Scheduling and Associating Reports Against a Query or Case Series
  • Working in the Scheduled Reports Group Dialog Box
    • Viewing the Reports in a Group
    • Viewing, Sorting, and Searching the Report Groups
    • Using the Command Buttons
  • Associating a Report Group
• Creating and Scheduling a New Report Group
  • Working in the Reports Scheduling Dialog Box
    • Entering the Report Name and Description
    • Setting Up the Schedule
    • Setting Up to Run the Reports Now
    • Defining E-Mail Information
    • Browsing and Sorting the List of Available Reports
    • Selecting and Adding Reports to the Group
    • Entering Required Pre-filters and Selecting a Report Format
    • Saving the Schedule
• Scheduling a Report without a Query
• Listing of the Standard Reports
  • Case Processing Reports
  • Compliance Reports
  • Configuration Reports
  • General Reports
  • Management Reports
  • Pharmacovigilance Reports

10 Generating and Scheduling Standard Reports - BIP

• About Standard Reports
  • Case Series, ETL, and Association
  • Browser Configuration
  • Report Cover Page
    • Page Header
    • Page Contents
    • Page Footer
• Working in the Reports Page
• Generating Reports
• Scheduling and Associating Reports Against a Query or Case Series

11 Creating Custom Reports - Cognos

• General Report Writer Information
• Creating a New Report
  • Using Case Series Criteria and Case Series Name in New Report
  • Using Case Series Criteria and Name with Other Objects
• Editing Reports
  • Filtering Data
  • Sorting Data
  • Summarizing Data
  • Formatting Data in Reports
  • Performing Calculations
• Changing the Report Layout
  • Creating a Chart
  • Grouping by Row Headings
  • Ungrouping a Report
  • Creating Crosstab Reports
    • Summarizing the Sections in the Report
    • Converting to a Crosstab Report
    • Creating Sections in the Report
    • Swapping Rows and Columns
  • Running the Report in Specific Formats
• Saving and Accessing Saved Reports
  • Saving Reports
  • Saving a Report in a New Folder
  • Accessing Report Writer Library
• Using SMQs in Report Writer

12 Creating Custom Reports - BusinessObjects

• General Report Writer Information
• Creating a New Report
• Editing Reports
  • Filtering Data
  • Sorting Data
  • Summarizing Data
  • Formatting Data in Reports
• Turning the Report Layout into a Table or Chart
• Saving and Accessing Reports
  • Saving Reports
  • Accessing the Report Writer Library
• Using SMQs in Report Writer
• Creating AdHoc Reports

13 Creating Custom Reports - BIP

• Creating a New Report
• Editing Reports
• Changing the Report Layout

14 Working in a Multi-Tenant Environment

• Assumptions and Constraints
• Data Segregation
  • Module-Wise Impact
  • Enterprise Short Name in Argus Insight
• Login and Navigation
  • Single Sign-On Accounts
    • Using Separate URLs to Access the Applications
    • Opening Argus Insight from Other Applications
  • Enterprise Switching
  • Direct Access
• Global Homepage
  • Application Access Portlet
  • Global Enterprise Management Portlet
    • Overview of the Global Enterprise Management Page Layout
    • Adding a New Enterprise
    • Copying an Enterprise
  • Global User Management Portlet
• Power Queries and Case Series
  • Importing a Case Series
  • Modifying a Case Series
  • Deleting a Case Series
  • Exporting a Case Series
• Common Profile Switches
• ETL Scheduler
• Reports
  • Cognos Reports
    • Standard Reports
    • Custom Reports
    • Report Writer Reports
    • Reports in the Cognos Environment
  • BusinessObjects Reports
    • Standard Reports
    • Custom Reports
    • Report Writer Reports
    • Reports in the BusinessObjects Environment

15 Using the Administration Tools

• Support for Multibyte Characters
• Using Schema Creation Tool
• Opening the ADMINISTRATION TOOLS Page
• Configuring Personal Options
• Maintaining Argus Insight Lists for Cognos
  • Configuring the Argus Insight Application Profile Switches
    • Accessing and Modifying the Profile Switches
    • Adding a New Profile Switch
    • Configuring the Excel Version for Cognos Reports
    • Listing of the Common Profile Switches
  • Configuring European Union Countries
    • Adding a Country to the European Union List
    • Deleting a Country from the European Union List
  • Mapping Case Workflow States
  • Configuring Categories
  • Configuring Duration Value Bands
  • Configuring Derivation Functions
    • Opening the Derivation Fields Dialog Box
    • Icons in the Derivation Fields Dialog Box
    • Field Mapping Derivation Rules
    • Fields and Check Boxes in the Derivation Fields Dialog Box
  • Configuring Case Series Modification Justification
  • Configuring Case Series Un-freezing Justification
• Maintaining Argus Insight Lists for BusinessObjects
  • Configuring the Argus Insight Application Profile Switches
    • Accessing and Modifying the Profile Switches
    • Adding a New Profile Switch
    • Listing of the Common Profile Switches
  • Configuring European Union Countries
    • Adding a Country to the European Union List
    • Deleting a Country from the European Union List
  • Mapping Case Workflow States
  • Configuring Categories
  • Configuring Duration Value Bands
  • Configuring Derivation Functions
    • Opening the Derivation Fields Dialog Box
    • Icons in the Derivation Fields Dialog Box
    • Field Mapping Derivation Rules
    • Fields and Check Boxes in the Derivation Fields Dialog Box
  • Configuring Case Series Modification Justification
  • Configuring Case Series Un-freezing Justification
  • Configuring Holiday Schedule Management
  • Configuring Product Designated Medical Event Configurations
  • Configuring Measurable Suppliers
  • Configuring Non-Core Sites
  • Configuring Acceptable Delay Justifications
• Running the Extract, Transform, and Load Process
  • Data Integrity Checks Before ETL
  • Initial ETL Versus Incremental ETL
  • Scheduling the ETL
  • Monitoring the Progress of the ETL
• Securing User Accounts, Groups, and Access Rights
  • Creating New User Groups
  • Copying Groups
  • Modifying Existing Groups
  • Deleting Existing Groups
  • Modifying User Accounts
• Viewing the Audit Log

Glossary