Summary
This article covers configuring the monitor visit plan.
Table of Contents
The plans for when monitoring visits will occur at the sites for each study are managed through the Visit Plan form, one of many Configurable Forms. It is from this screen that the monitoring visit strategy and visit frequency is defined. A Site Visit plan can be defined, through the Site Visit Projection table, which will be used to track and project monitoring visits. What is displayed on this form can be configured from CTMS Settings.
You must build your visit plan frequencies to plan/report on site visits.
Access Visit Plan Form
The Visit Plan form for existing studies can be access by selecting Visit Plan under the Monitoring Plans sub-menu under the Clinical Plans sub-menu for the study.
Default Fields
The Visit Plan form contains the Monitoring Visit Projection table and the following fields by default.
Define Monitoring Visit Strategy Field
The Define Monitoring Visit Strategy field is a multiline text field used to describe the strategy the study will be using for monitoring visits.
Define Visit Frequency Field
The Define Visit Frequency field is a multiline text field used to describe the frequency monitoring visits will occur.
Site Visit Projection Table
The Site Visit Projection Table will display all visit frequencies added. The Name of Site Visit column will display the name of the visit and by selecting the name the user is taken to the Site Visit Frequency form.
The Editor Options column contains the delete icon which allows the ability to remove a Site Visit Frequency record. A confirmation screen will appear when the Delete Icon is selected. Selecting Ok will delete the frequency; selecting Cancel will not delete the frequency.
Add Site Visit Frequency Form
The Add Site Visit Frequency form can be accessed by clicking the “Add Site Visit Frequency” action found in the Actions Menu on the Visit Plan form.
The Site Visit Frequency form for existing visits may be accessed by clicking on the Name of Site Visit in the Visit Projection table and the Edit Site Visit Frequency form shall appear.
The Add Site Visit Frequency form contains the following fields by default:
Name of Site Visit
The Name of Site Visit field is a text field used to identify the name of the monitoring visit. By default, the Name of Site Visit field is a required field and a black alert will fire if the name of the visit is not provided.
Visit Type Field
The Visit Type field is a dropdown field used to identify the type of monitoring visit. While other types can be changed by updating the associated Managed List in CTMS Settings, by default the options are:
- Evaluation
- Initiation
- Interim
- Close-out
By default, the Site Visit Type field is a required field and a black alert will fire if the type of visit is not provided.
Visit Description
The Visit Description is a multi-text field offering the opportunity to describe the details or expectations of this visit. This description will appear during the visit planning process.
Reporter Roles
The Reporter Roles field is a multi-choice field where the roles of individuals expected to report on this visit should be listed. Completion of this field affects the Study Site Visit form table and visit reporting options.
Dependent Baseline Field
Visits can be scheduled independent of a baseline trigger or a relationship to other events can be identified to build a programmed visit plan. The Dependent Baseline field is the field utilized to identify those relationships. This field affects how site visits are planned in each study site’s Site Visit Form, as well as performance analysis on visit forecasting/scheduling.
A visit baseline can be:
- Independent (None)
- An existing visit (frequency has already been created)
- A Study Milestone as presented in the Clinical Plan
- A Site Milestone as presented in the Clinical Plan (though target dates are configured within each study site)
Dependent Baseline: None
If no baseline is chosen, no additional steps are necessary to complete the Dependent Baseline field.
Dependent Baseline: Existing Visit, Study Milestone, Site Milestone
If an existing visit is selected, the Specify Window must be completed to create the expected timeline between the baseline and new visit.
If a Study or Site Milestone is selected, you will first be prompted to select which milestone, then the Specify Window must be completed to create the expected timeline between the baseline milestone and new visit.
Note: If you want your initiation visit to occur 30 days after your selected baseline, with 5 days' grace period on either side of 30, you would complete the fields as seen in the image below.
- Target Unit: Unit of measurement between baseline and visit (Days, Weeks, Month, Years)
- Target: Amount of selected Target Unit you expect between baseline and visit
- Window Unit: Unit of measurement for target grace period (Days, Weeks, Month, Years)
- +Window: Amount of selected Window Unit after target
- -Window: Amount of selected Window Unit before target
Once specified, the timeframe will be added to the form, with the option to clear or edit the specified window.
Is this a Recurring Visit? Field
The Is this a Recurring Field is a dropdown field used to identify if this monitoring visit repeats. The options are Yes and No, No is selected by default.
- If No, no additional steps are required.
- If Yes and the Dependent Baseline was identified, select one of the following options:
- Baseline is another visit:
- Plan Next Visit after Each Scheduled Visit
- Complete Maximum Iteration if available
- Complete Specify Window to create recurring expectation
- Recur after each “name of selected baseline visit”
- Baseline is a milestone:
- Plan Next Visit after Each Scheduled Visit
- Complete Maximum Iteration if available
- Complete Specify Window to create recurring expectation
Save
Updating Existing Visit Plans for 14.6 Plan Visit Functionality
There are a few new fields to complete if you plan to take advantage of all of the visit planning functionality. Currently, your visit frequencies do not allow you to create a visit’s recurring pattern; you are only able to designate it as a recurring visit. In 14.6 you can build out the timeframe for recurring visits, which will then be used for planning visits in the Site Visits area of each study site.
- After the release, we suggest that you:
- Access your current studies’ Visit Plans
- Complete any new/missing fields
- Identify the recurring visit frequencies
- Complete the recurring visit fields
- Select to plan the recurrence based on each scheduled visit of this visit type (in this case, Interim), completing the Maximum Iterations and Window fields.
OR - Select to plan the recurrence based on the dependent baseline that was chosen for this frequency (in this case, the First Patient In visit)
- Select to plan the recurrence based on each scheduled visit of this visit type (in this case, Interim), completing the Maximum Iterations and Window fields.
Importing Monitoring Visit Plan
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This information can be imported as part of the Study import. Click here for more information.
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