Analyze 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. You can view the statistics regarding the number of protocol deviations per study within a single page.
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In the CTMS application header, select the REPORT tab.
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On the page that opens, in the left pane, expand Study Quality Control and select Protocol Deviation.
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In the Protocol Deviation table that appears, view the list of protocol deviations created for each available study.
Figure 1. Viewing protocol deviation report
Tip
You can switch the table view to see the list of protocol deviations grouped by study, country/region, or site. Simply select the necessary grouping option from the workspace toolbar above the table.
Once viewed, you can now export the protocol deviation report to your computer if needed.