Configure Oracle Argus Safety for PBRER

To specify the inclusion of PBRER sections:

1. Select the Summary Tabulation tab from the Oracle Argus Safety ICH PSUR Configuration screen.
2. To include Section 6.2, select the Include Section 6.2 checkbox. The system does not use other query criteria available under Section 6.2.
3. To include Section 6.3, select the Include Section 6.3 checkbox. From the other query criteria available, only Case Classification and Observe Study Type are used for identifying the Non-Interventional studies.
   • The system populates Case Classification with values from the Case Classification code list.
   • The system populates Observe Study Type with values from the Case Classification code list where E2B code values are not null.
   • The Cumulative Start Date in Section 6.2 and Section 6.3 is separate from the Include Section 6.2 and Include Section 6.3 checkboxes.

The system ignores all other configuration parameters on this tab except PBRER configuration, Include Summary of Cases Missing Assessments, and Include Summary of Unlocked Cases.

Figure 5-1 ICH PSUR Summary Tabulations Tab

Description of "Figure 5-1 ICH PSUR Summary Tabulations Tab"

For more information, see:

• Product Types in Study Configuration to Support PBRER and DSUR