ICSR Process Overview

Individual Case Safety Reports (ICSRs) contain information about a suspected adverse reaction by an individual patient to one or more medicinal products.

E2B is the international standard for transmitting adverse event data, which was developed by the International Council for Harmonisation (ICH).

This flowchart shows the steps to follow when working with ICSR reports.

Note:

This section applies only to Argus Safety environments. For Safety One Argus environments, refer to the Oracle Life Sciences Consolidated Intake User Guide.

The following table describes each step of the process.

Task	Description
Log in	Log in to Oracle Argus Safety.
Case Data Entry	Enter case information.
Schedule E2B Report	Schedule an E2B Report for a case manually or using auto-schedule.
View E2B Report	View a scheduled E2B report in the ICSR Viewer and check for validation errors.
Transmit E2B Report	Transmit the E2B reports by using the Bulk Reporting screen in Oracle Argus Safety.
View Status	View the status of a transmitted E2B report.
View Acknowledgement	View the detailed acknowledgement information from a trading partner or a regulatory authority.

The following flowchart displays the steps to import E2B reports through Oracle Argus Interchange:

The following table describes each step of the import process.

Task	Description
Incoming E2B Reports	View the incoming E2B reports.
View E2B Reports	View an incoming E2B report in the ICSR Viewer.
Duplicate Search	Search for possible duplicate cases in Oracle Argus Safety.
View Difference Report	View differences between the current XML being imported (a message not yet imported into the database), the current case data in the database and the last imported case.
Accept/Reject	Accept or reject single or multiple E2B Follow-up/Initial reports.
View Process ICSR Reports	View the processed ICSR reports.

For more information, see:

• Minimum Requirement for Electronic Report Generation