Set visit window
A visit window refers to a specific timeframe during which a study subject is expected to complete a scheduled visit or assessment. In clinical trials, participants are often required to visit a site or undergo specific assessments at predetermined intervals. The visit window provides a degree of flexibility around the exact date of the scheduled visit as it defines a range of acceptable dates within which the visit needs to occur.
In Study Designer, you can configure a window for each of the created visits using an anchor. An anchor is a reference visit that serves as the baseline for the occurrence of the next visit according to the day specified as the earliest and latest. The corresponding visit forms become available in the EDC system for data entry according to the specified window schedule.
For example, a study has scheduled visits every two weeks. The window for a specific visit is defined between Day 12 and Day 15. This means the subject can come in for the visit on any day between the 12th and the 15th day after the visit specified as an anchor has occurred. As long as the visit takes place within this window, the data can be entered into corresponding visit forms in EDC.
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In the Study Designer application header, select the CRF DESIGN tab.
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In the toolbar, select the latest draft CRF version marked with the respective unlock symbol
, otherwise, you cannot perform any actions.
Figure 1. Selecting latest draft CRF version
Tip
The identifier next to the study name aids you in diversifying between the Locked
CRF
version unavailable for edits and Unlocked one that you can amend and configure.
Figure 2. Unlocked vs locked CRF version
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In the left pane that appears, select the study node.
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In the contents panel that appears, select the Visit and Cycle tab.
Figure 3. Selecting option to view visits and cycles
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From the workspace toolbar of the page that opens, select Set Visit Window
to start defining the window for necessary
visits considering columns and actions explained in the following table.
Figure 4. Defining visit window
Element
Details
Visit information
Visit Name
Represents the name of the visit.
Visit Type
Represents the type of visit.
Parent Folder Name
Represents the name of the folder where the current visit is located.
Category
Represents the category of the visit.
# of Repeat Visits
Represents the number of times the unscheduled visit needs to repeat in EDC.
User Add
Represents the status of the unscheduled visit whether it has been requested by some study participant. This toggle cannot be switched on or off since it is inactive.
Required actions
Set Window
Switch this toggle on to set a window for a corresponding visit.
Anchor
Select an anchor for the visit. This anchor serves as a baseline for the current visit, meaning this visit can only occur after the visit that is indicated as an anchor.
Select Initial to define the visit as the very first one. Only one visit from the list can be specified as an initial.
Scheduled Visit Days
Enter the number of days that must pass after the anchor visit for the current visit to become available for data entry in EDC. The scheduled visit days do not need to be specified for the initial visit.
Earliest Visit Days
Enter the minimum number of days that must pass after the anchor visit for the current visit to become available for data entry in EDC. The earliest visit days do not need to be specified for the initial visit.
When you set the Early Visit Days to 0, this indicates that the patient's Earliest Visit Date and Latest Visit Date must fall on the same date as the scheduled visit within the time frame from 00:00 AM to 11:59 PM.Latest Visit Days
Enter the maximum number of days that must pass after the anchor visit for the current visit to stop being available for data entry in EDC. The latest visit days do not need to be specified for the initial visit.
When you set the Early Visit Days to 0, this indicates that the patient's Earliest Visit Date and Latest Visit Date must fall on the same date as the scheduled visit within the time frame from 00:00 AM to 11:59 PM.Show Visit Window Required
Switch the Show Visit Window Required toggle on or off to show or hide the actions required for the configuration of visit windows in the table.
Select Save Visit Window
to save the visit window configuration.
Once saved, the visit window configuration is applied. The corresponding visit with their forms will become available in EDC for data entry according to the specified visit window schedule.