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Configure form dependency

The Study Designer application has various tools to maintain different form settings. One such setting incorporates the configuration of form dependency. This dependency is set up using the SAS language syntax to define in what order and based on what condition the forms need to become available in EDC for data entry. The purpose of the rule configuration is to streamline the assessment process by omitting irrelevant forms based on the respondent's initial response. It helps ensure that the assessment focuses on gathering only pertinent information.

For example, there are Adverse Events and Adverse Events (Details) forms. The first form includes the question "Subject experienced adverse events." The dependency can be configured to show the Adverse Events (Details) form if the response to the indicated question on the Adverse Events form is "Yes" so the adverse event details can be provided in a separate form.

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

To configure a form 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 one of the following:

    • Unique Form and then select the needed form within. In the contents panel that opens, go to the Unique Form Dependency tab.

      Tip

      By configuring a form dependency for a unique form, this dependency is applied to all linked visit forms.

      Accessing unique form dependency tab
      Figure 2. Accessing unique form dependency tab

    • The needed visit and then select the form within. In the contents panel that opens, go to the CRF Form Dependency tab.

      Accessing visit form dependency tab
      Figure 3. Accessing visit form dependency tab

  4. In the Expression text box of the page that opens, start designing an expression. 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.

    Tip

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

    Designing form dependency expression
    Figure 4. Designing form dependency expression

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

    Configuring additional form dependency expression
    Figure 5. Configuring additional form dependency expression

  6. Then from the workspace toolbar, select save_icon_red.png to save the configured form dependency rule.

    Saving form dependency expression
    Figure 6. Saving form dependency expression

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

    Activating form dependency expression
    Figure 7. Activating form dependency expression

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

In this section:

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.

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Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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.