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View E2B R3 import record audit trail

In PV, you can manually upload an XML file or receive such a file via a gateway to import your case data to the system and create an ICSR for further management.

The import process suggests various actions with the file, such as processing, review of extracted cases, and so on. Thus, there is an option to view the audit trail for the import record and have descriptive information on the operations performed with the imported data.

To view the audit trail for an E2B R3 import record

  1. In the PV application header, select the INTAKE tab.

  2. On the page that opens, from the left pane, select E2B R3 Import.

    Accessing E2B R3 import
    Figure 1. Accessing E2B R3 import

  3. Based on where your imported file resides, select the Manual Upload or Gateway Received tab.

  4. In the table that appears, locate the record of your interest and from the Actions column next to it, select More more_icon.png > Audit Trail list_icon_gray.png.

    Tip

    You can see the uploaded files with cases based on the study access permission granted via ADMIN.

    Selecting to view audit trail
    Figure 2. Selecting to view audit trail

  5. In the Audit Trail dialog that opens, view the log of operations performed with the imported file.

    Viewing import data audit trail
    Figure 3. Viewing import data audit trail

  6. Select ok_button_red_white.png to close the dialog.

You have viewed the audit trail for the imported data.

In this section:

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.