1. Japan User's Guide
  2. Use the ICSR Viewer
  3. Open the ICSR Viewer

Open the ICSR Viewer

The ICSR Viewer enables you to view your E2B reports in the following views. A new switch is added to identify the default viewing format of the PMDA E2B R3 report in the ICSR viewer.

View Description

SGML

Displays the E2B report in the SGML format. This view is applicable for non-Japanese E2B reports.

Decoded View

Displays all the E2B elements in groups and subgroups. Elements eligible for decoding with their decoded values in parentheses.

Decoded View supports the following Oracle Argus Safety Japan specific views for Japanese E2B reports:

  • I - Decoded View
  • J - Decoded View

I and J Decoded Views display following information on the screen in Japanese language:

  • Field Labels on the screen
  • Folder Tree Values
  • Decoded description values wherever there is a text.

In this view, the application lists the ICH and PMDA element in the decoded formats as per the applicable decoded value based on the allowed values set for the element against the profile. Besides, the element number and decoded element description (both English and J) are based on the "Data Additional Information Tab Case Form 1-28 Element R3" and Title/J Title respectively as per PMDA E2B R3 Mapping.

CIOMS

For details on the CIOMS view, refer to the "E2BCIOMSMapping" document. This view is applicable for non-Japanese E2B reports.

HL 7 View

In this view, the application opens the report within the HL7 message format as per the PMDA Guidance (as explained in the report generation section).

MedWatch

For details on the MedWatch view, refer to the "E2BMedWMapping" document. This view is applicable for non-Japanese E2B reports.

I-SGML

Displays ICSR I data items in SGML format.

J-SGML

Displays ICSR J data items in SGML format.

I-Decoded

Displays the Decoded view for all the I elements of a PMDA E2B report.

J-Decoded

Displays the Decoded view for all the J elements of a PMDA E2B report.

PMDA Report Form

Displays the appropriate PMDA form, as per the reporting category.

Native XML View

In native XML view, the application lists all the ICH and PMDA specific elements as per the PMDA E2B R3 Mapping.

You can also view the E2B Report from the Oracle Argus Safety application.

Click the Draft or Final status for a report in the Regulatory Reports tab of Case Form.

For more information, see:

Parent topic: Use the ICSR Viewer