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Copy ICSR from existing

In PV, you can create an ICSR based on the safety data pulled from EDC via data extraction task management, by creating a report from scratch and inserting all the required data manually, or by uploading an XML file. You can also copy an existing ICSR, for example, if you need to create a new ICSR for the same study but with some details different.

To copy an ICSR from an existing
  1. In the PV application header, select the ICSR tab.

  2. On the ICSR List page that opens, in the table, locate the ICSR that you want to copy and in the Actions column next to it, select More more_icon.png > Copy copy_icon.png.

    Copying ICSR
    Figure 1. Copying ICSR

  3. In the Copy dialog that opens, enter how many copies you want to create and then select the forms that you want to include in your copied ICSR version(s).

    Selecting forms to include in copied report
    Figure 2. Selecting forms to include in copied report

    Tip

    Click select_all_button.png to select all the forms from the list and include them in the copied ICSR(s).

    Click deselect_all_button.png to clear the selection for all the forms from the list, and do not include them in the copied ICSR(s).

  4. Select copy_button.png to complete the ICSR copying.

Upon copying, the new ICSR(s) are created and you can proceed to its forms amendment if needed.