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Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• The Oracle Health Sciences Safety Suite
• Documentation Accessibility
• Finding Information and Patches on My Oracle Support
• Finding Oracle Documentation
• Related Documents
• Conventions

1 Introduction

2 BI Publisher and the Argus Safety Application

• 2.1 Enabling BI Publisher Aggregate Reporting
• 2.2 Configuring the Argus BIP Integration
• 2.3 Report Execution Flow from BI Publisher and Argus Safety
  • 2.3.1 Report Execution Flow from Argus Safety
  • 2.3.2 Report Execution Flow from BI Publisher
• 2.4 Periodic Configuration Identification of BIP Parameters
  • 2.4.1 Subject of Report Tab
  • 2.4.2 Product Selection Tab
  • 2.4.3 Inclusion Criteria and Special Interest AE Tabs
  • 2.4.4 Line Listing Tab
  • 2.4.5 Summary Tabulations Tab
  • 2.4.6 UD Summaries Tab
  • 2.4.7 Security Tab
• 2.5 Generating and Modifying a Case Series
  • 2.5.1 Generating a Case Series
  • 2.5.2 Modifying a Case Series
  • 2.5.3 Advanced Condition Library
  • 2.5.4 Deleting a Case Series
• 2.6 Running BIP Reports through Argus Safety
• 2.7 Running Reports through BIP Console
• 2.8 Running Reports through the BIP Scheduler
• 2.9 Data Security
• 2.10 Report Output Management
• 2.11 Viewing Aggregate Reports from Argus Safety
• 2.12 Background Periodic Report Status

3 Aggregate Reporting Data Model

• 3.1 Aggregate Reporting Data Model

4 Reporting Algorithms

• 4.1 Labeling Algorithm
  • 4.1.1 Listedness Determination based on Event Assess Table
  • 4.1.2 Listedness Determination Based on Event Assess Table and Datasheets
  • 4.1.3 Listedness Determination based on Datasheets
  • 4.1.4 Additional Considerations for Determining Listedness
• 4.2 Choosing a Categorization Algorithm for Compiling PBRER and DSUR
• 4.3 Initial or Follow-up Algorithm
  • 4.3.1 Using Submission Tracking
  • 4.3.2 Using Initial Receipt Date

5 Argus Insight Compatibility

• 5.1 Configuring Changes for Argus Insight RPD Integration
  • 5.1.1 Common Profile Entries
  • 5.1.2 Data Purging

6 Periodic Benefit Risk Assessment Report

• 6.1 Report Objective
• 6.2 Configuring Argus Safety for PBRER
  • 6.2.1 Product Types in Study Configuration for Supporting PBRER and DSUR
• 6.3 PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
  • 6.3.1 Generating the Case Series for Section 6.2
    • 6.3.1.1 Company or Configured Study Cases
    • 6.3.1.2 Non-Company or Non-Configured Study Cases
  • 6.3.2 Grand Totals
  • 6.3.3 Section 6.2 Layout
• 6.4 PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
  • 6.4.1 Case Selection
  • 6.4.2 Section 6.3 Layout
• 6.5 Sample Report
  • 6.5.1 Cover Page
    • 6.5.1.1 Information on Drugs and Studies
  • 6.5.2 Labels Configured for Drugs in the Drug List Format
  • 6.5.3 Cases with Missing Assessments
  • 6.5.4 Trailer Section
• 6.6 Executing the PBRER from BIP

7 Development Safety Update Report

• 7.1 Report Objective
• 7.2 Argus Configuration for DSUR
  • 7.2.1 Subject of Report Tab
  • 7.2.2 Line Listing Tab
  • 7.2.3 Summary Tabulation Tab
  • 7.2.4 UD Summaries Tab
  • 7.2.5 Security Tab
  • 7.2.6 Scheduling and Template Tabs
• 7.3 DSUR Main Line Listings
  • 7.3.1 Grouping
  • 7.3.2 Main Line Listing
  • 7.3.3 Report Parameters for Printing Reactions or Serious Events
  • 7.3.4 Summary Columns
  • 7.3.5 DSUR Main Line Listing Format
  • 7.3.6 DSUR Fatal Line Listing
• 7.4 Summary Tabulations of Serious Adverse Events
  • 7.4.1 Groupings
  • 7.4.2 Count Breakdown in Tabulations based on IMP, Comparator, Placebo, and Blinded
  • 7.4.3 DSUR Tabulation Format
  • 7.4.4 Totals
  • 7.4.5 Summary Counts
• 7.5 Executing a DSUR from BIP

8 Post Marketed Aggregate Report

• 8.1 Report Objective and Sections
• 8.2 PMAR Sections
• 8.3 Argus Configuration (PSUR) for PMAR
• 8.4 Main Line Listing
  • 8.4.1 Grouping
• 8.5 Line Listing Columns
• 8.6 Summary Columns for Count
• 8.7 Report Format
  • 8.7.1 Ad Hoc Line Listing Sections
  • 8.7.2 Summary Tabulations
  • 8.7.3 PMAR Summary Tabulation
  • 8.7.4 Grouping
• 8.8 HCP Summary Tabulation Columns
  • 8.8.1 Format for HCP Summary Tabulations
• 8.9 Summary Tabulation for Consumer Cases
• 8.10 Format for Clinical Trial Summary Tabulations
  • 8.10.1 Cumulative Summary Tabulation for Serious Unlisted Events
• 8.11 Executing a PMAR from BIP

A Report Parameters and their Definitions

Glossary