2 Overview

This chapter provides an overview of the product. It contains:

Section 2.1, "Out-of-the-box Periodic Reports"
Section 2.2, "Supported Output Formats"
Section 2.3, "Security Limitations"
Section 2.4, "Catalog"
Section 2.5, "Scheduler Support"
Section 2.6, "Template Design"
Section 2.7, "Database Code Wrapping"

2.1 Out-of-the-box Periodic Reports

The out-of-the-box Argus Safety BI Publisher Periodic Reporting feature provides the following periodic reports:

The Periodic Benefit Risk Assessment Report (PBRER)
The Development Safety Update Report (DSUR) also known as Clinical Trial Periodic Report (CTPR)
The Post Marketed Aggregate Report (PMAR, also called PSUR)

2.2 Supported Output Formats

Out-of-the-box Argus Safety BI Publisher Periodic reports support the following output formats by default:

You can also get the output in an XML format. The out-of-the-box reports are not designed to support the CSV format. However, you can prepare a custom report supporting the CSV format.

2.3 Security Limitations

2.3.1 Authorization

Argus Safety BI Publisher Periodic Reporting has been certified for the following security models:

BI Publisher Security
Fusion Middleware Security

2.3.2 Authentication

The Argus Safety BI Publisher Periodic Reporting feature is certified for Oracle Access Manager (OAM) and Single Sign-on (SSO).

2.4 Catalog

Argus Safety BI Publisher Periodic Reporting supports the Oracle BI Publisher File System Catalog.

2.5 Scheduler Support

Argus Safety BI Publisher Periodic Reporting supports Quartz scheduler.

2.6 Template Design

Out-of-the-box (OOTB) Aggregate reports use RTF templates.

2.7 Database Code Wrapping

All Argus Safety objects are code wrapped. However, to facilitate and encourage customers to handle their own customizations, the system does not wrap database code under the BIP Owner user.

Oracle recommends that customers use the APIs to alter or extend the functionality. Using the APIS enables upward compatibility and Oracle support.