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Configure item dependency rule

In Study Designer, you can configure case report forms (CRFs) for clinical trial visits with various tools and form field items—text fields, checkboxes, dropdown menus, date pickers, and more. You can place these items on the form canvas, arrange them as needed, and make sure they are associated with the corresponding variables.

When maintaining a form, you can configure a dependency between question items—specific answers to some questions might trigger new questions to appear on the form, alternate the answers of another question, or else. The dependency is set up using the SAS language syntax to define in what order and based on what condition the question items need to become available on the form in the EDC application for data entry. The purpose of the rule configuration is to streamline the assessment process by omitting irrelevant fields based on the respondent's initial response. It helps ensure that the assessment focuses on gathering only pertinent information.

For instance, for the subject dispensing form, you configured a rule that if for the question "Has Unnumbered Items" the answer is "Yes," the "# of Unnumbered Item" field must appear because if "No," then there are no items to count. Considering that the variable that stores the answer for the "Has Unnumbered Items" question is CMUNNUM, the rule expression can look as follows:

$*.*.CMUNNUM == 'Y'

However, there can be the case for a more intricate logic, where the "Has Unnumbered Items" field was "Yes" and the "# of Unnumbered Item" field was entered with respective data. Then the "Has Unnumbered Items" field value is changed to "No" and by the previous logic, the "# of Unnumbered Item" field must disappear but you want it to remain on the form if it has data entry. You can do so by adding to the existing expression the following one:

NotEmptyIgnoreRule($*.*.CMUNNUM == 'Y')

Item dependency expression example
Figure 1. Item dependency expression example

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

To configure an item dependency rule

  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 2. Selecting latest draft CRF version

  3. In the left pane that appears, expand the unique form directory of any visit. Then select the needed form.

    Important

    Note that by updating a unique form, you introduce changes to all visit forms linked to it and vice versa.

    Accessing form to configure
    Figure 3. Accessing form to configure

  4. On the form content page that appears, next to the needed item, select Item Dependency Rule icon_rule.png.

    Accessing item dependency rule setup
    Figure 4. Accessing item dependency rule setup

  5. On the page that opens, go to the Depend tab.

  6. In the Expression text box of the Depend page that opens, start designing an expression. Use the following entry options when designing an expression:

    • Enter Shift + @ to automatically prompt functions preconfigured on the backend.

    • Enter Shift + # to automatically prompt conditions preconfigured on the backend.

    • Enter 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.

    Tip

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

    Designing item dependency expression
    Figure 5. Designing item dependency expression

  7. Optionally, select button_expression.png to add an expression placeholder that you can use for the purpose of organization.

    Configuring additional item dependency expression
    Figure 6. Configuring additional item dependency expression

  8. Then from the workspace toolbar, select save_icon_red.png to save the configured item dependency rule.

    Saving item dependency expression
    Figure 7. Saving item dependency expression

  9. From the same workspace toolbar, turn on the Activate toggle to make the item 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 item remains available without any precondition.

    Activating item dependency expression
    Figure 8. Activating item dependency expression

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

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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.