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View differences between follow-up and previous safety data

The safety data in PV is an AE/SAE event data sent from EDC that serves as a base for ICSR creation. When you have both initial and follow-up data sent from EDC, you can compare the available versions to detect their differences.

To view differences between the follow-up and the previous safety data

  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 follow-up safety data that you need to compare to the previous version. Then in the Actions column next to it, select View Differences differences_icon.png.

    Comparing follow-up data to initial
    Figure 2. Comparing follow-up data to initial

    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. On the page that opens, in the left pane, navigate between subtabs to view the details. All the differences—edits, new additions, or deletions—are highlighted. Review the available differences as explained in the following table.

    Reviewing differences between follow-up and previous data
    Figure 3. Reviewing differences between follow-up and previous data

    Element

    Details

    diff_icon.png

    At the top of the left pane, represents the total number of differences discovered by the system between the follow-up safety data and the previous version.

    plus_icon_blue.png

    • At the top of the left pane, represents the total number of new additions discovered by the system in the follow-up data compared to the previous version.

    • Next to the subtab name, represents the number of new additions in that specific tab discovered by the system in the follow-up data compared to the previous version.

    edit_icon_yellow.png

    • At the top of the left pane, represents the total number of edits discovered by the system in the follow-up data compared to the previous version.

    • Next to the subtab name, represents the number of edits in that specific tab discovered by the system in the follow-up data compared to the previous version.

    trash_can_icon_red.png

    • At the top of the left pane, represents the total number of deletions discovered by the system in the follow-up data compared to the previous version.

    • Next to the subtab name, represents the number of deletions in that specific tab discovered by the system in the follow-up data compared to the previous version.

    info_icon_light_gray.png

    Select this icon to view the summary of all the changes made to the data as depicted in the following image.

    Viewing changes summary
    Figure 4. Viewing changes summary

    info_icon_green.png

    Represents the number of differences between form field values in the follow-up data compared to the previous version.

    control_icons_panel.png

    Select these control icons to conveniently switch between differences discovered by the system—go to the first, next consequent, previous, or last one.

    Only Show Difference

    Turn this toggle on/off to hide/display the subtabs under which the system has not discovered any differences between the follow-up data and the previous version.

  5. Select cancel_button.png to close the safety data details and return to EDC Import List.

You have compared the follow-up safety data to the previous version. You can also view the safety data change history.

In this section:

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 is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

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.