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Contents
Title and Copyright Information
Preface
Audience
Where to Find More Information
Documentation Accessibility
1
Introduction
2
Overview
2.1
Flexible Reports - What's in the Box
2.2
Output Formats
2.3
Scheduling
2.4
Report Templates
2.5
Database Code Wrapping
3
Flexible Aggregate Reporting Framework
3.1
Generic Architecture
4
Flexible Aggregate Reporting - Database
4.1
Database Architecture
4.1.1
Flexible Aggregate Reporting - Database Objects
4.1.2
Tables
4.1.3
Views
4.1.4
Database Link
4.1.5
Java Stored Procedure
4.1.6
Packages
4.1.7
Database Jobs
4.2
Argus Application Schema Objects
4.2.1
Tables
4.2.2
Packages
4.3
Access Grants to BI Publisher Owner
5
Flexible Aggregate Reporting Design
5.1
Flexible Aggregate Reporting Design Structure
5.1.1
BI Publisher Data Model
5.1.2
BI Publisher Report Layout
5.2
Aggregate Report Data Flow
5.2.1
Argus Safety UI Entry
5.2.2
BI Publisher Data Flow
6
Extending a Flexible Aggregate 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
6.1.5
Adding or Modifying a View
6.1.6
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
6.2.6
Lexical Parameters
6.3
Creating a Custom Report
6.4
Blinding Functionality
6.5
Flexible Data Re-categorization
7
PMDA E2B (R3) Paper Forms - Framework
7.1
Generic Architecture - PMDA (R3) Paper Reports
8
PMDA (R3) Paper Report - Database
8.1
PMDA E2B (R3) Paper Report - DB Architecture
8.1.1
DB Objects
8.1.2
Tables
8.1.3
Java Objects
8.1.4
Packages
8.1.5
Argus Application Schema
8.1.6
ACCESS GRANTS to BI Publisher Owner
9
PMDA (R3) Paper Report Design
9.1
BI Publisher Periodic Reports Design Structure
9.2
PMDA (R3) Data Model
9.2.1
Data Set
9.2.2
Event Triggers
9.2.3
Parameters
9.3
PMDA (R3) Paper Report templates
9.3.1
Argus Safety UI Entry
10
Extending PMDA (R3) Report
10.1
Database Layer
10.2
Extending the BI Publisher Data Model
10.3
Extending through E2B PMDA Profile
10.4
Configuring Blinding for PMDA (R3)
10.4.1
10.4 Configuring Blinding for PMDA (R3)
A
Troubleshooting
A.1
Troubleshooting PMDA (R3) Paper Forms
A.2
Troubleshooting Flexible Aggregate Reports
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