Change subject phase
Each phase of a subject participating in a study is reflected on the Subject Information page of the EDC application. It is designed to answer the question of whether it is reasonable to move a subject forward in a clinical trial or whether they should remain in the current phase to gather more information or perform needed study-related activities.
For example, you cannot enroll a subject in a study and start collecting clinical data until the subject passes the screening test.
So, if a certain phase has already been completed, you need to move the subject further along manually.
Important
The subject phase can also be changed automatically by the system (according to the design of the trial) if the CRF data meet the conditions configured in the Study Designer application. To put it simply, when all forms are completed for a given subject visit, the system automatically changes the subject's phase to the phase specified according to the study design.
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In the EDC application header, select the STUDY INFO tab.
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On the page that opens, in the left pane, expand the Subject option.
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In the menu that appears, select the Subject Information subtab.
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In the Subject List table that appears, locate the subject ID of your interest.
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In the Next Phase column, next to the subject, select the name of the next phase to which your subject must be moved further.
Figure 1. Changing subject phase
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In the confirmation dialog that opens, confirm your action by selecting
.
Figure 2. Confirming phase change
Important
The notification verbiage of the dialog varies depending on the phase from/to which you change your subject.
You may also need to specify the date of the subject phase change if the subject phase configuration requires you to do so. The selected date and time are set as specified, however, if your timezone differs from the site time zone, you see that by the offset value next to the time, such as "-5" or "+2".
Figure 3. Entering date of subject phase change
Once saved, the subject phase is changed.