Design triggering questions for safety case integration with Safety

Configure a question to trigger the integration of subject case data with Safety.

Permissions

You must be assigned to a study role that includes the Edit Safety Case Design permission to design triggering questions.

Details for study designers

  • We recommend designing the triggering question on an adverse event visit and adverse event form (repeating form).
  • Triggering rules can be applied to multiple questions within the same form. If multiple triggering rules are designed within the same form, should one of the forms evaluate as true, then Oracle Clinical One Platform will create and transmit the case to Safety.

    Caution:

    We do not recommend applying triggering rules to multiple questions on different forms, as this could lead to duplicate cases.
  • You should not apply a triggering rule to the flat portion of a 2-section form.
  • Should a form contain multiple questions with safety case triggering rules, the triggering rule labels should be identical across all of these questions.
  • You should not add triggering rules to multiple questions.

Follow the steps below to design a triggering question.

  1. Open the draft version of your study. For more information, see Open a study's design.
  2. In the Forms tab, create a new form or open an existing one.
  3. Select Add to add a new question. You can also work on an existing question.

    Note:

    text fields cannot be used to trigger the creation of safety cases. Only choice questions can be used, such as radio button, drop-downs, or check box.
  4. Expand the Rules side panel, then select Trigger Safety Case.
    1. Define the triggering condition for the rule by selecting one of the answers from the When Selection is dropdown.
    2. Select a label for your safety case using the Label for Safety Case dropdown.

    Note:

    The label you select for the safety case is reflected in the History panel, on the Subjects page. We recommend choosing the title of the adverse event itself.
  5. Define the triggering conditions for the safety case.
  6. Select Save or Save and Close.

Parent topic: Question types and settings