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Edit SAE form field

In the EDC application, the maintenance of the serious adverse event (SAE) forms occurs under the STUDY INFO > SAE Form Define subtab. Here you can add fields to the form as well as edit the existing ones.

To edit the SAE form field

  1. In the EDC application header, select the STUDY INFO tab.

  2. On the page that opens, in the left pane, select SAE > SAE Form Define.

  3. In the SAE Form Define table that appears, locate the field of your interest and in the Actions column next to it, select Edit pencil_icon.png.

  4. In the Edit dialog that opens, update the elements as explained in the New SAE form field dialog elements table of the Add new field to SAE form section.

    Editing SAE form field
    Figure 1. Editing SAE form field

  5. Select save_button_white_red.png to implement the changes.

Upon saving, the field is updated. You can also activate/inactivate the SAE form fields.

In this section:

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.