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Export protocol deviation report

A protocol deviation refers to any departure from the study protocol that was originally approved by the responsible committee. Protocol deviations can take different forms, such as deviation from the study procedure, use of prohibited medication, failure to report adverse events or other safety concerns, and so on. The statistical data related to the protocol deviation summary can be exported in the XLSX file so you can view it offline on your computer.

To export the protocol deviation report
  1. In the CTMS application header, select the REPORT tab.

  2. On the page that opens, in the left pane, expand Study Quality Control and select Protocol Deviation.

    Accessing protocol deviation
    Figure 1. Accessing protocol deviation

  3. Above the Protocol Deviation table that appears, from the workspace toolbar, select Export export_icon.png.

    Exporting protocol deviation report
    Figure 2. Exporting protocol deviation report

    Tip

    If you want to view or download the historic files of the protocol deviation report, then from the workspace toolbar, select Export History export_history_icon.png. In the Export History dialog that opens, next to the file you want to download, select download_icon.png and save it to your computer and use it offline.

    Exporting historic files
    Figure 3. Exporting historic files

Once selected, the protocol deviation report becomes downloaded to your computer. You can then open it to view it offline.