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Oracle® Health Sciences Pharmacovigilance Operational Analytics User and Administrator Guide
Release 1.0
E23554-01
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Contents
List of Figures
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Title and Copyright Information
Preface
Audience
Documentation Accessibility
Finding Information and Patches on My Oracle Support
Finding Documentation on Oracle Technology Network
Related Documents
Conventions
Part I Using Oracle Health Sciences Pharmacovigilance Operational Analytics
1
Getting Started with OPVA
1.1
Overview
1.1.1
What Can I Do Using Oracle Pharmacovigilance Operational Analytics?
1.2
Architecture
1.3
Reporting
1.4
Regulatory Compliance
1.4.1
Tracking Data
1.4.2
Managing ETL Versions
1.4.3
Executing the ETLs
1.4.4
Security
2
Using OPVA
2.1
Overview
2.2
Accessing Oracle Health Sciences Pharmacovigilance Operational Analytics
2.2.1
Viewing a Dashboard
2.3
Using Oracle Business Intelligence
2.3.1
Logging In
2.3.2
Working with Oracle Business Intelligence
2.3.2.1
Oracle Business Intelligence Interactive Dashboards
2.3.2.2
Oracle Business Intelligence Analysis
2.3.2.3
Oracle Business Intelligence Agents
2.4
Performing Common Tasks in Oracle Business Intelligence
2.4.1
Signing Out of Oracle Business Intelligence Enterprise Edition
2.4.2
Using Online Help
2.5
Navigating in Oracle Business Intelligence
2.5.1
What is Available to You After Accessing Oracle BI?
2.5.2
What is the OBIEE Home Page?
2.5.3
What is the OBIEE Global Header?
2.5.4
Setting Preferences
2.5.4.1
Steps to Set Preferences
2.5.4.2
Exporting the Oracle BI Results
2.5.4.2.1
Add to Briefing Book
2.5.4.2.2
About Briefing Books
2.5.4.2.3
Adding Content to Briefing Books
2.5.4.3
Sorting Options Menu and Buttons
2.5.4.3.1
Sorting Mechanisms
2.5.5
Drilling In Results
2.5.5.1
What Is Drilling?
2.5.5.2
Where Can I Drill?
2.5.5.2.1
Drilling in Attribute Columns
2.5.5.2.2
Drilling in Hierarchical Columns
2.5.5.2.3
Drilling in Graphs
2.5.6
Printing an Oracle BI Dashboard or Saved Request
2.5.7
Emailing an Oracle BI Dashboard Page or Request
3
Working with Reports
3.1
Pre-defined Reports
3.1.1
Opening and Using Dashboards
3.2
Custom Reports
3.3
Viewing Reports With Your Apple iPhone
Part II Administration
4
Extract Transform Load Programs
4.1
ETL Architecture
4.1.1
Oracle Health Sciences Pharmacovigilance Operational Analytics Hierarchy
4.2
Executing the ETL Execution Plans
4.3
Customizing an ETL Execution Plan
4.4
Creating an ETL Execution Plan
4.5
Modifying an ETL Execution Plan
4.6
Scheduling an ETL Execution Plan
4.7
Customizable User Exits in OPVA ETLs
5
Maintaining the Repository and Warehouse
5.1
Maintaining the Oracle Health Sciences Pharmacovigilance Operational Analytics Repository
5.1.1
Modifying the Repository
5.2
Maintaining the Oracle Health Sciences Pharmacovigilance Operational Analytics Data Warehouse
5.2.1
Derivations
5.2.2
Extensions
5.2.3
Substitutions
5.2.4
Modifying Data Warehouse Tables
6
Performance Considerations
6.1
Conformed Dimensions in OPVA
6.2
Aggregate Facts in OPVA
6.3
Creation of Prompts and Filters
6.3.1
Mandatory Prompts
6.3.1.1
Creating a mandatory field in page-level prompts
6.3.1.2
Setting up default values
6.4
OBIEE Caching and Cache Seeding
7
Implementing Security
7.1
About Security in Oracle Health Sciences Pharmacovigilance Operational Analytics
7.1.1
Example
7.2
Setting Up User Authentication
7.2.1
Creating User Accounts in DAC
7.2.2
Creating Users and Groups for OPVA
7.2.3
Implementing Security using OAM and Configuring SSL for OPVA
Part III Appendices
A
Dashboards and Reports
A.1
Oracle Pharmacovigilance Operational Analytics Dashboards
A.1.1
Case Processing History
A.1.1.1
Case Processing History Dashboard Pages
A.1.1.1.1
Case Processing Volume History
A.1.1.1.2
Case Processing Compliance History
A.1.1.1.3
Workflow State Repetition History
A.1.2
Case Processing Management
A.1.2.1
Case Processing Management Dashboard Pages
A.1.2.1.1
Case Processing Volume Management
A.1.2.1.2
Case Processing Compliance Management
A.1.2.1.3
Workflow State Compliance Management
A.1.3
Personal User Dashboard
A.1.3.1
Personal User Dashboard Pages
A.1.3.1.1
Personal User Case History
A.1.3.1.2
Personal User Case Management
A.2
Oracle Pharmacovigilance Operational Analytics Reports
A.2.1
Completed Case Versions - Volume Overview
A.2.1.1
Audience
A.2.1.2
Report Type
A.2.1.3
Location
A.2.1.4
Dimensions
A.2.1.5
Supplementary Prompts
A.2.1.6
Reports Referenced
A.2.1.7
Reports Referencing This Report
A.2.1.8
Column Descriptions
A.2.2
Completed Case Versions – Volume Trend
A.2.2.1
Audience
A.2.2.2
Report Type
A.2.2.3
Location
A.2.2.4
Dimensions
A.2.2.5
Supplementary Prompts
A.2.2.6
Reports Referenced
A.2.2.7
Reports Referencing This Report
A.2.2.8
Column Descriptions
A.2.3
Completed Case Versions – Line Listing
A.2.3.1
Audience
A.2.3.2
Report Type
A.2.3.3
Location
A.2.3.4
Dimensions
A.2.3.5
Supplementary Prompts
A.2.3.6
Reports Referenced
A.2.3.7
Reports Referencing This Report
A.2.3.8
Column Descriptions
A.2.4
Completed Case Versions – Lock Compliance Overview
A.2.4.1
Audience
A.2.4.2
Report Type
A.2.4.3
Location
A.2.4.4
Dimensions
A.2.4.5
Supplementary Prompts
A.2.4.6
Reports Referenced
A.2.4.7
Reports Referencing This Report
A.2.4.8
Column Descriptions
A.2.5
Completed Case Versions – Lock Compliance Proportion
A.2.5.1
Audience
A.2.5.2
Report Type
A.2.5.3
Location
A.2.5.4
Dimensions
A.2.5.5
Supplementary Prompts
A.2.5.6
Reports Referenced
A.2.5.7
Reports Referencing This Report
A.2.5.8
Column Descriptions
A.2.6
Completed Case Versions – Lock Compliance Trend
A.2.6.1
Audience
A.2.6.2
Report Type
A.2.6.3
Location
A.2.6.4
Dimensions
A.2.6.5
Supplementary Prompts
A.2.6.6
Reports Referenced
A.2.6.7
Reports Referencing This Report
A.2.6.8
Column Descriptions
A.2.7
Completed Workflow States – Line Listing
A.2.7.1
Audience
A.2.7.2
Report Type
A.2.7.3
Location
A.2.7.4
Dimensions
A.2.7.5
Supplementary Prompts
A.2.7.6
Reports Referenced
A.2.7.7
Reports Referencing This Report
A.2.7.8
Column Descriptions
A.2.8
Completed Case Version Routing – Line Listing
A.2.8.1
Audience
A.2.8.2
Report Type
A.2.8.3
Location
A.2.8.4
Dimensions
A.2.8.5
Supplementary Prompts
A.2.8.6
Reports Referenced
A.2.8.7
Reports Referencing This Report
A.2.8.8
Column Descriptions
A.2.9
Repeated Workflow States – Volume Overview
A.2.9.1
Audience
A.2.9.2
Report Type
A.2.9.3
Location
A.2.9.4
Dimensions
A.2.9.5
Supplementary Prompts
A.2.9.6
Reports Referenced
A.2.9.7
Reports Referencing This Report
A.2.9.8
Column Descriptions
A.2.10
Repeated Workflow States – Volume Proportion
A.2.10.1
Audience
A.2.10.2
Report Type
A.2.10.3
Location
A.2.10.4
Dimensions
A.2.10.5
Supplementary Prompts
A.2.10.6
Reports Referenced
A.2.10.7
Reports Referencing This Report
A.2.10.8
Column Descriptions
A.2.11
Pending Cases – Volume Overview
A.2.11.1
Audience
A.2.11.2
Report Type
A.2.11.3
Location
A.2.11.4
Dimensions
A.2.11.5
Supplementary Prompts
A.2.11.6
Reports Referenced
A.2.11.7
Reports Referencing This Report
A.2.11.8
Column Descriptions
A.2.12
Pending Cases – Line Listing
A.2.12.1
Audience
A.2.12.2
Report Type
A.2.12.3
Location
A.2.12.4
Dimensions
A.2.12.5
Supplementary Prompts
A.2.12.6
Reports Referenced
A.2.12.7
Reports Referencing This Report
A.2.12.8
Column Descriptions
A.2.13
Pending Cases – Lock Compliance Overview
A.2.13.1
Audience
A.2.13.2
Report Type
A.2.13.3
Location
A.2.13.4
Dimensions
A.2.13.5
Supplementary Prompts
A.2.13.6
Reports Referenced
A.2.13.7
Reports Referencing This Report
A.2.13.8
Column Descriptions
A.2.14
Pending Cases – Lock Compliance In Days
A.2.14.1
Audience
A.2.14.2
Report Type
A.2.14.3
Location
A.2.14.4
Dimensions
A.2.14.5
Supplementary Prompts
A.2.14.6
Reports Referenced
A.2.14.7
Reports Referencing This Report
A.2.14.8
Column Descriptions
A.2.15
Pending Workflow States – Compliance Overview
A.2.15.1
Audience
A.2.15.2
Report Type
A.2.15.3
Location
A.2.15.4
Dimensions
A.2.15.5
Supplementary Prompts
A.2.15.6
Reports Referenced
A.2.15.7
Reports Referencing This Report
A.2.15.8
Column Descriptions
A.2.16
My Completed Workflow States – Volume Trend
A.2.16.1
Audience
A.2.16.2
Report Type
A.2.16.3
Location
A.2.16.4
Dimensions
A.2.16.5
Supplementary Prompts
A.2.16.6
Reports Referenced
A.2.16.7
Reports Referencing This Report
A.2.16.8
Column Descriptions
A.2.17
My Repeated Workflow States – Volume Overview
A.2.17.1
Audience
A.2.17.2
Report Type
A.2.17.3
Location
A.2.17.4
Dimensions
A.2.17.5
Supplementary Prompts
A.2.17.6
Reports Referenced
A.2.17.7
Reports Referencing This Report
A.2.17.8
Column Descriptions
A.2.18
My Completed Case Versions – Line Listing
A.2.18.1
Audience
A.2.18.2
Report Type
A.2.18.3
Location
A.2.18.4
Dimensions
A.2.18.5
Supplementary Prompts
A.2.18.6
Reports Referenced
A.2.18.7
Reports Referencing This Report
A.2.18.8
Column Descriptions
A.2.19
My Completed Workflow States – Line Listing
A.2.19.1
Audience
A.2.19.2
Report Type
A.2.19.3
Location
A.2.19.4
Dimensions
A.2.19.5
Supplementary Prompts
A.2.19.6
Reports Referenced
A.2.19.7
Reports Referencing This Report
A.2.19.8
Column Descriptions
A.2.20
My Pending Cases – Overview
A.2.20.1
Audience
A.2.20.2
Report Type
A.2.20.3
Location
A.2.20.4
Dimensions
A.2.20.5
Supplementary Prompts
A.2.20.6
Reports Referenced
A.2.20.7
Reports Referencing This Report
A.2.20.8
Column Descriptions
A.2.21
My Assigned Cases – Line Listing
A.2.21.1
Audience
A.2.21.2
Report Type
A.2.21.3
Location
A.2.21.4
Dimensions
A.2.21.5
Supplementary Prompts
A.2.21.6
Reports Referenced
A.2.21.7
Reports Referencing This Report
A.2.21.8
Column Descriptions
A.2.22
My Unassigned Cases – Line Listing
A.2.22.1
Audience
A.2.22.2
Report Type
A.2.22.3
Location
A.2.22.4
Dimensions
A.2.22.5
Supplementary Prompts
A.2.22.6
Reports Referenced
A.2.22.7
Reports Referencing This Report
A.2.22.8
Column Descriptions
A.2.23
Other Assigned Cases – Line Listing
A.2.23.1
Audience
A.2.23.2
Report Type
A.2.23.3
Location
A.2.23.4
Dimensions
A.2.23.5
Supplementary Prompts
A.2.23.6
Reports Referenced
A.2.23.7
Reports Referencing This Report
A.2.23.8
Column Descriptions
A.2.24
My Completed Case Version Routing – Line Listing
A.2.24.1
Audience
A.2.24.2
Report Type
A.2.24.3
Location
A.2.24.4
Dimensions
A.2.24.5
Supplementary Prompts
A.2.24.6
Reports Referenced
A.2.24.7
Reports Referencing This Report
A.2.24.8
Column Descriptions
B
OPVA Presentation Catalog
B.1
Dimensions in OPVA Presentation Catalog
B.2
Facts in OPVA Presentation Catalog
B.3
Oracle Argus Safety Sources for OPVA Presentation Catalog
C
Troubleshooting
C.1
Verify whether the DAC client is able to use Informatica commands
C.2
Unable to run Informatica Workflow from DAC
C.3
Aborting a Workflow
C.4
Unable to Sign In to OPVA
Index