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View safety data change history

All the changes in the safety data are of vital importance as they reflect updates about the subject's AE/SAE. In PV, the changes applied to the safety data are saved and trackable via the Change History feature.

To view the safety data change history

  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 change history. Then in the Actions column next to it, select More more_icon.png > Change History history_icon.png.

    Selecting to view safety data change history
    Figure 2. Selecting to view safety data change history

    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 Change History dialog that opens, you can find the log of all the changes made to the safety data, what kind of change it was (for instance, new data was added), who performed the action and when, and more.

    Safety data history of changes
    Figure 3. Safety data history of changes

  5. Select ok_button_red_white.png to close the dialog.

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

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.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

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.