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View safety data audit trail

All the operations performed with the safety data are of vital importance as they reflect the complete process of data report creation and management. In PV, the operations with safety data are trackable via the Audit Trail feature.

To view the safety data audit trail

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

    Accessing intake management
    Figure 1. Accessing intake management

  2. On the page that opens, in the left pane, select the EDC Import subtab.

  3. In the EDC Import List that appears, locate the safety data for which you need to view the audit trail. Then in the Actions column next to it, select More more_icon.png > Audit Trail list_icon_gray.png.

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

    Tip

    You can only see the cases based on the study access permission granted via ADMIN.

    To locate the needed safety data faster, filter the table by study name, site code, subject ID, or other parameters.

  4. In the Audit Trail dialog that opens, you can find the log of all the operations performed with the safety data, who operated, and when.

    Safety data audit trail
    Figure 3. Safety data audit trail

  5. Select ok_button_red_white.png to close the dialog.

You have viewed the safety data audit trail. Upon closing the dialog, you return to the EDC Import List table. You can also select to view the safety data change history.

In this section:

In Pharmacovigilance, all the data on adverse events and other occurrences related or suspected to be related to investigational products. In eClinical, it is mostly data collected from subjects during clinical trials; this data helps to evaluate product safety and efficacy.

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.