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Download SAE report file from history

SAE report comprises information related to the SAE occurrences during a clinical trial. This information is pulled from the SAE forms completed under the DATA ENTRY tab of the EDC application. Having the full SAE report is vital for the FDA approval process.

In EDC, you can export SAE report data as an XLSX file or download a ZIP archive comprising SAE-related forms in PDF format and use them as per your business needs. All the previously exported files are stored in Export History and can be downloaded from there if needed.

To download the SAE report files from the export history
  1. In the EDC application header, select the STUDY INFO tab.

  2. On the page that opens, in the left pane, select the SAE > SAE Report subtab.

  3. On the SAE Report page that opens, from the workspace toolbar, select History history_icon.png.

    Accessing export history
    Figure 1. Accessing export history

  4. In the Export History dialog that opens, next to the file version that you want to download, select Export download_icon.png.

    Downloading file from export history
    Figure 2. Downloading file from export history

Once downloaded and saved, the file becomes available on your computer. Select ok_button_red_white.png to close the dialog.