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Contents

Title and Copyright Information

Preface

• Audience
• Where to Find More Information
• Documentation Accessibility

1 Introduction

2 Overview

• Flexible Reports - What's in the Box
• Output Formats
• Scheduling
• Report Templates
• Database Code Wrapping

3 Flexible Aggregate Reporting Framework

• Generic Architecture

4 Flexible Aggregate Reporting - Database

• Database Architecture
  • Flexible Aggregate Reporting - Database Objects
  • Tables
  • Views
  • Database Link
  • Java Stored Procedure
  • Packages
  • Database Jobs
• Argus Application Schema Objects
  • Tables
  • Packages
• Access Grants to BI Publisher Owner

5 Flexible Aggregate Reporting Design

• Flexible Aggregate Reporting Design Structure
  • BI Publisher Data Model
    • Data Sets
    • Event Triggers
    • Parameters
  • BI Publisher Report Layout
• Aggregate Report Data Flow
  • Argus Safety UI Entry
  • BI Publisher Data Flow

6 Extending a Flexible Aggregate Report

• Database Layer
  • Configuration Extensibility
  • Extending with User Exits
  • Extending Global Temporary Tables
  • Extending using Custom Objects
    • Adding New Columns to GTT or RM Tables
    • Filling Custom Tables
    • Filling Custom Views
    • Filling Custom Packages
  • Adding or Modifying a View
  • Adding a Column to the Existing Table
• Extending the BI Publisher Data Model
  • Data Model Query Naming Convention
  • Data Model Nested Queries
  • Data Structure Groups
  • DSUR Summary Table Naming Conventions
  • Case Series Tables
    • Common Queries (lexicals) Used in Reports
  • Lexical Parameters
• Creating a Custom Report
• Blinding Functionality
• Flexible Data Re-categorization

7 PMDA E2B (R3) Paper Forms - Framework

• Generic Architecture - PMDA (R3) Paper Reports

8 PMDA (R3) Paper Report - Database

• PMDA E2B (R3) Paper Report - DB Architecture
  • DB Objects
  • Tables
  • Java Objects
  • Packages
  • Argus Application Schema
  • ACCESS GRANTS to BI Publisher Owner

9 PMDA (R3) Paper Report Design

• BI Publisher Periodic Reports Design Structure
• PMDA (R3) Data Model
  • Data Set
  • Event Triggers
  • Parameters
• PMDA (R3) Paper Report templates
  • Argus Safety UI Entry

10 Extending PMDA (R3) Report

• Database Layer
• Extending the BI Publisher Data Model
• Extending through E2B PMDA Profile
• Configuring Blinding for PMDA (R3)
  • 10.4 Configuring Blinding for PMDA (R3)

A Troubleshooting

• Troubleshooting PMDA (R3) Paper Forms
• Troubleshooting Flexible Aggregate Reports