Oracle Safety One Intake updates

Summary

This release offers Oracle Safety One Intake to enhance intake capabilities, and provides a unified interface for managing adverse event reports

Description

UI updates

A new Safety One Intake tab is added that redirects you to the Safety One Intake module. This module centralizes intake functionalities, offering an improved interface for managing adverse event reports.

The Intake Worklist within Oracle Safety One Intake replaces the traditional ICSR Pending screen, providing additional features such as PII (Personally Identifiable Information) support and case assignment capabilities.

  • English E2B(R2) and E2B(R3) reports ingested via the interchange service now appears in the Safety One Intake > Intake Worklist and Monitor List, replacing the Reports > ICSR Pending, Processed & Utilities > ICSR > Failed Imports screens.
  • PMDA E2B (R2) and E2B (R3) reports continue to appear in the traditional ICSR Pending and Processed screens.

Additionally, when follow-ups are received for a case, a notification appears in the case form, enabling case processors to take necessary actions. The application allows follow-ups to be held, if the case is not ready for merging due to submission deadlines or other reasons that is configurable.

Likewise, an indication about such notifications appear on the Worklist New, Worklist Open, and Case Actions Open screens.

A new Intake ID column is added to the Case Form > Follow-up section, displaying the follow-ups merged into the case. You can click this Intake ID to view the individual follow-up information.

For more details, refer to the Safety One Intake Release Notes > Consolidated Intake Processing Workflows.

Console updates

To support intake processing, the following changes are made in Argus Console:

  • A new check box, Hold Follow-up Merge during Intake, is added to Argus Console > System Configuration > Workflow > States.
  • A new node, Intake Processing, is added to Argus Console > System Configuration > System Management (Common Profile Switches). This node is at the enterprise level.
  • To support auto-assignment for both case and intake records, use Argus Console > System Configuration > System Management (Common Profile Switch) > Workflow > Case Routing > Enable Auto opening of the next case/intake record option.
  • A new check box, Allow Narrative Processing During Intake, is added to Code List > Argus Code List > Reporting Destination > EDI.

For more details, refer to the Safety One Intake Release Notes > Changes to the Argus Console.