About collecting safety case data when integrating with Safety

Learn about configuring a study to automatically integrate safety case data with Safety. This includes configuring the forms you want to include in the transfer to Safety, which includes mapping each question to an E2B(R3) compliant format.

Once data mapping is complete, adverse event data is integrated with Safety more efficiently, which improves the accuracy of the data in Safety.

Prerequisites

You must first perform the following tasks to be able to integrate your study with Safety:
  1. Confirm the sponsor user has enabled the Integrate with Safety System toggle at the study level. For more information, see Enable adverse event data collection.
  2. Ask your user administrator to add the Edit Safety Case Design permission to your study role.

    Note:

    Study designers who do not have this permission assigned can still see the safety design properties in read-only mode.

Workflow

Configure a form to trigger the creation of a safety case. To do this, set up a rule on a choice question, such as a radio button or dropdown question. You must then mark questions whose data is included in the safety case, some of which you can mark as mandatory for the case’s creation. You can also set up a question to trigger the creation of a follow-up safety case when data is updated after the initial submission of the safety case. As you work on your forms, you can also map questions to an E2B(R3) compliant format. Based on the E2B(R3) mapping, you can also select a specific E2B(R3) codelist, which ensures that data is captured appropriately in Safety.

Once a site user enters data that satisfies the triggering condition of the triggering rule you defined, the safety case is integrated with Safety. The data contained in the safety case includes all available form data that was mapped and marked for inclusion during study design. Once all of the mandatory questions are completed, Oracle Clinical One Platform sends the safety case through Oracle Clinical One Digital Gateway for processing by the Safety team.

E2B(R3) mapping

For any data that is to be integrated with Safety, E2B(R3) data mapping is required at the question level.

Caution:

Unmapped data will not be integrated with Safety.

Begin working on your study's design

Refer to the sections below to prepare your study for adverse event data collection:

Parent topic: Question types and settings