6 Using the ICSR Viewer

The ICSR Viewer enables you to open E2B files and view them in different formats.

Note:

The term E2B that is used in this document refers to E2B (R2), E2B (R3), and eVAERS reports.

You can print these files from the ICSR viewer. This chapter includes discussions on the following:

  • Opening the ICSR Viewer

  • Exporting an XML File

6.1 Opening the ICSR Viewer

The ICSR Viewer enables you to view your E2B reports in the following views:

View Description
XML Displays the report in the XML format. This view is applicable for E2B reports.
Decoded View Displays all the data elements in groups and subgroups. Elements are eligible for decoding with their decoded values in parentheses. A link is provided in the Decoded View to view the attachments that are sent along with the report.

The ICSR Viewer provides the decoded view format for the eVAERS, eMDR, and E2B reports.

For eMDR XML reports, the MedWatch box numbers are displayed instead of Data Element Number.
HL7 View This view is applicable for only E2B (R3) eMDR and eVAERS reports.This view displays the report in HL7 format.

The data element number and data element description is displayed as a comment for all the data elements that are part of E2B (R3) Regulatory guidelines from ICH, EMA, CDRH, PMDA, and CBER.
CIOMS For details on the CIOMS view, refer to the E2BCIOMSMapping document. This view is applicable for only E2B (R2) reports.
MedWatch For details on the MedWatch view, refer to the E2BMedWMapping document. This view is applicable for only E2B (R2) reports.

6.2 Exporting an XML File

The system enables you to use the following procedure to export an XML file.

  1. Click the Final E2B report type on the Regulatory Reports tab.

  2. When the system opens the ICSR Viewer window, select XML from the View Format drop-down list.

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  3. When the system displays the contents of the XML file, click Export.

  4. When the system displays the XML report, click File -> Save As.

  5. When the system opens the Save As Dialog box:

    1. Enter a name for the file.

    2. Browse to the folder where the file is to be saved

    3. Click Save to save and export the XML file.

      Note:

      Exporting an E2B report can only be done from the XML view on final reports. If you select draft, the Export button becomes unavailable.