2 Overview

This chapter provides an overview of the product.

Flexible Reports - What's in the Box

Periodic Reports

  • Periodic Benefit Risk Assessment Report (PBRER)

  • Development Safety Update Report (DSUR)

  • The Post Marketed Aggregate Report (PMAR, also called PSUR)

Expedited Reports

  • PMDA R3 Paper Forms 1-6

Output Formats

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

  • PDF

  • RTF

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.

Scheduling

Oracle Argus Flexible Reporting Framework supports Quartz scheduler.

Report Templates

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

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.