Clinical One Cloud Service to Safety integration

Use this integration to automatically send adverse event data from Clinical One Cloud Service to Safety in an E2B(R3) compliant format.

Overview

The Clinical One Cloud Service to Safety integration automates the exchange of adverse event data. This helps reduce reporting time and the complexities of data reconciliation, while also improving data accuracy by removing manual subject data entry in Safety.

To ensure that adverse event data is appropriately integrated, a sponsor user enables the Integrate with Safety System toggle on the General tab in the study settings, allowing the transmission of adverse event data. Study designers then configure rules to trigger safety case creation, design forms for data collection, and map required data to E2B(R3) fields for automatic transmission to Safety.

Provided that it is mapped to the E2B(R3) format, the adverse event data that is initially entered in Clinical One Cloud Service for a subject is automatically sent to Safety. Further updates made to the adverse event data is integrated to Safety based on the schedule of the integration.

Once the adverse event data is received and processed by the safety team, Safety sends an acknowledgment to Clinical One Cloud Service. Clinical One Digital Gateway processes this acknowledgment, which is reflected in Clinical One Cloud Service in the form of cases statuses and a Safety Case ID for each case.

To configure the Clinical One Cloud Service to Safety integration, including scheduling and E2B(R3) mapping, reach out to your Oracle point of contact.

Key considerations

Before your begin using the Clinical One Cloud Service to Safety integration consider the following.

• Clinical One Digital Gateway sends new safety cases and manually submitted updates to existing cases in near-real time. Regular updates are integrated to Safety based on the schedule of the integration as part of a singular follow-up, which includes all updates that have happened within that interval.
• We recommend scheduling your Clinical One Cloud Service to Safety integration to send updates every 24 hours.
• During study design, particular questions can be marked as mandatory for the creation of safety cases. Clinical One Cloud Service will not send adverse event data to Safety unless data has been entered for those questions.
• If an adverse event case is initiated in Clinical One Cloud Service while the Clinical One Digital Gateway integration is inactive, it receives a status of Transfer Failed, with a failure reason indicating that the integration is inactive.

Workflows

1. An adverse event is logged in Clinical One Cloud Service for a subject.
2. Clinical One Cloud Service checks that all mandatory adverse event data has been entered for that subject.
3. Clinical One Cloud Service notifies Clinical One Digital Gateway about the existence of a safety case that needs to be transmitted to Safety.
4. Clinical One Digital Gateway formats the adverse event data based on the E2B(R3) mapping configured by study designers.
5. Clinical One Digital Gateway creates the E2B(R3) data file with the adverse event data. It then places the file on the sFTP server.
6. Safety retrieves the data from the sFTP server and processes it.
7. Once data has been imported, either automatically or manually, Safety places an acknowledgment file on the sFTP server.
8. Clinical One Digital Gateway reads the acknowledgment file. It then updates the case's Safety Case Number in Clinical One Cloud Service. It also updates the status of the safety case in Clinical One Cloud Service.

   Note:

   If there is an issue while adverse event data is imported into Safety, the Clinical One Digital Gateway job will receive a status of Fail No Advance. For more information on job statuses, see Monitor reports and jobs for an integration or reach out to your Oracle point of contact.

For more information on how adverse event data is collected in Clinical One Cloud Service, see About adverse event data collection.