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

• 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:

  Triggering questions must only be designed on adverse event forms (repeating), in adverse event visits. Furthermore, 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 and the repeating portion at the same time.
• Should a form contain multiple questions with safety case triggering rules, the triggering rule labels should be identical across all of these questions.
• Should you change the triggering rule when using Advanced Study Versioning (ASV), we recommend leaving the safety case label unchanged. You should only change the triggering rule.
• 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.

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.
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.