View form item history of changes
In a clinical trial, you are dealing with sensitive data. It is vital to keep track of all changes and updates in the system. Thus, with EDC capabilities, you can review the change history of each form item, the previous and actual values, and see the reason for the data change and the user who changed it.
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In the EDC application header, select the DATA ENTRY tab.
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On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Accessing site
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In the Subject ID column, next to the needed subject, select the link representing the subject data to be entered.
Figure 2. Locating your subject
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On the Visit Overview page that opens, on the left, a panel with all subject visits is displayed. Expand the needed visit to open the forms associated with that visit.
Figure 3. Left panel. Visits and their forms
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Select the form of your interest by selecting it.
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On the form page that opens, in the Actions column next to the data piece of your interest, select
and in the resulting menu, select the Change History option.
Figure 4. Locating Change History option
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In the Change History dialog that appears, review the history of all the changes: values, reasons for changes, user name, and the date and time.
Figure 5. Viewing form history of changes
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Select
to close the dialog.
Once the dialog is closed, you return to the form page.