This chapter provides an overview of the product.
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
Out-of-the-box Argus Safety BI Publisher reports support the following output formats by default:
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.
Oracle Argus Flexible Reporting Framework supports Quartz scheduler.
Out-of-the-box (OOTB) Argus Flexible reports use RTF templates.
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.