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Oracle® Argus Insight Administrator's Guide
Release 7.0.2
E38587-01
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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