Oracle Argus Safety UI Entry

To configure a report, navigate to the Periodic Report Configuration screen and enter the required configuration. The system saves this data in the required configuration tables.

You can either generate the case series or run the BIP report in a single step. A case series is generated in both cases.

For an ICH PSUR configuration, the following case series can be generated:

  • Main Case Series
  • Cumulative Case Series
  • Section 6.2 Case Series
  • Ad hoc Case series (1-4) when ad hoc listings are supplied

For a CTPR configuration, only Main Case Series and Cumulative Case Series tables are present.

The case series are stored in the case series tables.