About collecting adverse event data when integrating data to Safety

Reduce reporting time, improve data accuracy, and enhance patient safety by enabling automatic adverse event data transmission for your study.

For a detailed description of how adverse event data collection works, see About collecting safey case data when integrating with Safety.

Once you have enabled the Integrate with Safety System toggle at the study level,
  • The Trigger Safety Case rule becomes visible to study designers, allowing them to apply it to questions. This allows them to define the criteria that will result in an adverse event case being created and sent to Safety.
  • The Include in Safety Case toggle becomes available for study designers. This allows study designers to select forms that contain data required for the adverse event case.
  • Once configured, the Oracle Clinical One Digital Gateway integration will send data from Oracle Clinical One Platform to Safety. For more information, see Clinical One to Safety.
  • Site and sponsor users with the appropriate permissions can start receiving notifications about the transmission of adverse event cases. For more information, see Subject notifications.

About adverse event data

If adverse event data needs to be sent to Safety, it must be mapped to an E2B(R3) compliant format by the study designer. To do this, the study designer maps the appropriate E2B(R3) data element to the form question.

Caution:

Unmapped data will not be transmitted to Safety.

To learn more about mapping data to an E2B(R3) compliant format at the form level, see E2B(R3) dictionary. Alternatively, for more information on mapping data at the integration level, reach out to your Oracle point of contact.

Users can also add E2B(R3) codelists to questions. This ensures that the data entered in these questions complies with a format expected in Safety. For more information, see About E2B(R3) codelists.

Prerequisites

For your adverse event data to be transmitted to Safety, the following are required:
  • The Manage Safety Settings permission, which allows a sponsor user to enable the Oracle Clinical One Platform to Safety integration.
  • The Oracle Clinical One Digital Gateway integration that sends adverse event data from Oracle Clinical One Platform to Safety must be configured. For more information, see Clinical One to Safety. You can also reach out to your Oracle point of contact for more information.
  • Study designers make the appropriate changes to the study design regarding safety mappings. For more information, see About collecting adverse event data.
  • Site users enter the required adverse event data. For more information, see About collecting adverse event data
Optionally, to effectively monitor adverse event cases in Oracle Clinical One Platform, you can have the following permissions assigned to your role:
  • Receive the Safety Case Creation Notification
  • Receive the Safety Case Updates Notification
  • Receive the Safety Case Cancellation Notification
  • Receive the Safety Case Acknowledgment Notification
  • Receive the Safety Case Could Not be Created Notification
For more information on these permissions, see Subject permissions.

Further details on adverse event data transmission to Safety

You can disable Integrate with Safety System for studies that already have this setting enabled. You should, however, bear the following in mind:
  • Existing form configurations, as configured by study designers, become read-only, but are not lost.
  • Rule configurations on questions, as configured by study designers, become read-only, but are not lost.
  • Any adverse event cases are preserved in subjects' history. These can no longer be modified and no data changes will be integrated to Safety.
  • Any Oracle Clinical One Digital Gateway integrations with Oracle Safety One Argus are disabled.
For questions that have been designed to create follow-up cases, Oracle Clinical One Platform does not generate follow-up cases whenever the following occur:
  • Form status changes
  • Query rule changes
  • SDV status changes
  • Question freezing
  • Question locking
  • Form signatures

Parent topic: Define settings