Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

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

1 Introduction

2 Overview

• 2.1 Out-of-the-box Periodic Reports
• 2.2 Supported Output Formats
• 2.3 Security Limitations
  • 2.3.1 Authorization
  • 2.3.2 Authentication
• 2.4 Scheduler Support
• 2.5 Template Design
• 2.6 Database Code Wrapping

3 Generic Architecture

• 3.1 Generic Architecture

4 Database Architecture

• 4.1 Database Architecture
  • 4.1.1 BI Publisher Periodic Reporting Owner Schema
  • 4.1.2 Tables
  • 4.1.3 Views
  • 4.1.4 Database Link
  • 4.1.5 Java Objects and Function Call
  • 4.1.6 Packages
  • 4.1.7 BI Publisher Owner Schema Database Jobs
• 4.2 Argus Safety Database Updates
  • 4.2.1 Table Changes Required
• 4.3 Access Grants to BI Publisher Owner

5 Design Structure

• 5.1 BI Publisher Periodic Reports Design Structure
  • 5.1.1 BI Publisher Data Model
    • 5.1.1.1 Data Sets
    • 5.1.1.2 Event Triggers
    • 5.1.1.3 Parameters
  • 5.1.2 BI Publisher Report Layout
• 5.2 Report Data Flow
  • 5.2.1 Argus Safety UI Entry
  • 5.2.2 BI Publisher Data Flow

6 Extending a BIP Report

• 6.1 Database Layer
  • 6.1.1 Configuration Extensibility
  • 6.1.2 Extending with User Exits
  • 6.1.3 Extending Global Temporary Tables
  • 6.1.4 Extending using Custom Objects
    • 6.1.4.1 Adding New Columns to GTT or RM Tables
    • 6.1.4.2 Filling Custom Tables
    • 6.1.4.3 Filling Custom Views
    • 6.1.4.4 Filling Custom Packages
  • 6.1.5 BIP Custom Schema for Cloud
  • 6.1.6 Adding or Modifying a View
  • 6.1.7 Adding a Column to the Existing Table
• 6.2 Extending the BI Publisher Data Model
  • 6.2.1 Data Model Query Naming Convention
  • 6.2.2 Data Model Nested Queries
  • 6.2.3 Data Structure Groups
  • 6.2.4 DSUR Summary Table Naming Conventions
  • 6.2.5 Case Series Tables
    • 6.2.5.1 Common Queries (lexicals) Used in Reports
  • 6.2.6 Lexical Parameters
• 6.3 Creating a Custom Report

A Parameters

B Blinding

• B.1 Blinding Logic

C Flexible Data Re-Categorization

• C.1 Flexible Data Re-Categorization

D Troubleshooting

• D.1 BIP Icon not Displayed Against Corresponding BIP Specific Fields in the Periodic Reporting Configuration
• D.2 BI Publisher Periodic report does not Execute from Argus UI
• D.3 Database Connection Errors
• D.4 BI Publisher Scheduled Report Output does not Show up
• D.5 ORA-01427: single-row sub-query returns more than one rowORA-06512: at "<bip_owner>.PKG_AGG_RPT" for p_updclinicaldrugrole procedure