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Configure visit dependency

In Study Designer, you have the possibility to configure a dependency between visits. The dependency is set up using the SAS language syntax to define in what order and based on what condition the visits need to become available in the EDC application for data entry.

For example, there is the Tumor Response Assessment 1 visit that includes the Disease Assessment form. If a healthcare professional indicates on this form that the subject's health is not improved after the treatment, such a subject will need to attend the Tumor Response Assessment 2 visit. The dependency between these visits is configured in Study Designer. When set up correctly, the Tumor Response Assessment 2 visit will become available for the subject right after the Tumor Response Assessment 1 visit is completed and the Disease Assessment form is completed appropriately.

For the studies with hierarchical design, where there is a master study and its substudies, you can set up dependencies for the visits of the substudies to rely on the visits of the master study.

For example, there is the Prescreening visit of the master study that includes the Compatibility Assessment form. If a healthcare professional indicates on this form that the subject is compatible to be screened for participation in the substudy, such a subject will need to attend the Screening visit that belongs to the substudy. When set up correctly, the Screening visit will become available in the substudy for the subject right after the Prescreening visit of the master study is completed and the Compatibility Assessment form is completed appropriately.

To configure a visit dependency

  1. In the Study Designer application header, select the CRF DESIGN tab.

  2. In the toolbar, select the latest draft CRF version marked with the respective unlock symbol unlocked_icon_purple.png, otherwise, you cannot perform any actions.

    Selecting latest draft CRF version
    Figure 1. Selecting latest draft CRF version

  3. In the left pane that appears, select the needed visit.

  4. On the page that opens, select the Visit Dependency tab.

    Accessing visit dependency setup
    Figure 2. Accessing visit dependency setup

  5. In the Expression text box, start designing an expression. Expand the visits and forms in the navigation tree to reference their variables in your expression.

    Tip

    For the substudy, you can see the visits and forms of the master study for which you can set up the dependency rule. These visits are marked with the respective master_indicator.png indicator.

    Use the following entry options when designing an expression:

    • Press Shift + @ to automatically prompt functions.

    • Press Shift + # to automatically prompt conditions.

    • Press Shift + $ to automatically prompt the list of visits, then forms, and then variables to select for the expression.

    • From the tree panel, select and drag the necessary variable to use it in the expression configuration.

    Designing visit dependency expression
    Figure 3. Designing visit dependency expression

  6. Optionally, select button_expression.png to add an expression placeholder that you can use for the purpose of organization. Add as many such expressions as needed.

    Configuring additional visit dependency expression
    Figure 4. Configuring additional visit dependency expression

  7. From the workspace toolbar of the Visit Dependency page, select Save save_icon_red.png to save the configured visit dependency.

    Saving configured expression
    Figure 5. Saving configured expression

  8. From the same workspace toolbar, turn on the Activate toggle to make the visit dependency active and applied in EDC once the CRF version is published. If the toggle is turned off, the dependency rule is not applied and the visit remains available without any precondition.

    Activating configured expression
    Figure 6. Activating configured expression

Once saved and activated, the visit dependency is configured and will be applied in EDC once the respective CRF version is published.

In this section:

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.