1 Introduction

This guide is for Argus Safety users who would like to print reports using the BI Publisher. The flexible output format of Argus Safety BI Publisher aggregate reports lets users customize the output format to suit their regulatory interpretations and business needs.

This guide contains the following chapters:

Table 1-1 Components of the Extensibility Guide

Chapter Name Description

Chapter 1, "Introduction"

Provides a basic overview about the topics that have been covered in this guide.

Chapter 2, "BI Publisher and the Argus Safety Application"

Describes the updates made to the Argus Safety application to support BI Publisher aggregate reports.

Chapter 3, "Aggregate Reporting Data Model"

Describes the Aggregate Reporting Data Model.

Chapter 4, "Reporting Algorithms"

Documents reporting algorithms.

Chapter 5, "Argus Insight Compatibility"

Describes Argus Insight compatibility with the BIP reporting framework.

Chapter 6, "Periodic Benefit Risk Assessment Report"

Details the Periodic Benefit Risk Assessment Report.

Chapter 7, "Development Safety Update Report"

Details the Development Safety Update Report.

Chapter 8, "Post Marketed Aggregate Report"

Details the Post Marketed Aggregate Report.