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 and J Decoded Views display following information on the screen in Japanese language:
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. |
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. |
XML View |
In native XML view, the application lists all the ICH and PMDA specific elements as per the PMDA E2B R3 Mapping. |
The PMDA Device Viewer enables you to view your PMDA Device reports in the following views:
View | Description |
---|---|
XML | This view is displayed by default.
Note: In future releases, common profile switches will be available to set the default view. |
Decoded | Displays all the elements in groups and subgroups. Elements eligible for decoding are displayed with their decoded values in parentheses. |
Paper View | Allows you to view the PMDA Device report as Form 8 or Form 10 PDF, depending on the report form. |
For more information, see: