Oracle Clinical One Platform to Safety integration
With the integration between Oracle Clinical One Platform and Safety, users now benefit from a more efficient transfer of adverse event data. Not only does the integration improve patient safety by reducing reporting time, but it also reduces the possibility of manual intervention and improves the quality of data for safety cases.
With this new integration, users are no longer required to create new adverse event reports from scratch in Safety. Oracle Clinical One Platform automatically creates and sends new safety cases to Safety along with the configured subject data.
Before you work with this feature
As a user manager, you should be aware of the new permissions introduced with this new feature. You should assign the new permissions to the designers, sponsor, and site users who work with safety cases.
| Permission | Type | Details |
|---|---|---|
| Edit Safety Case Design | Designer | Enables study designers to configure safety case design properties, such as applying the Trigger Safety Case rule to a question or mapping questions to the E2B(R3) format. |
| Cancel a Safety Case | Site |
Enables site users to dismiss or cancel a safety case. |
| Manage Safety Settings | Sponsor | Enables sponsor users to turn on the Integrate with Safety System toggle. |
| Modify a Safety Case | Site | Enables site users to edit safety cases after initial submission, which may include selecting or deselecting repeating forms, 2-section forms, and lab forms. Also enables site users to resend cases with a status of Failed. |
| Receive the Safety Case Creation Notification | Site, sponsor | Site users with this permission are notified of the creation of a new safety case for a subject. |
| Receive the Safety Case Updates Notification | Site, sponsor | Site users with this permission are notified whenever an existing safety case has been updated for a subject. |
| Receive the Safety Case Cancellation Notification | Site, sponsor | Site users with this permission are notified whenever an existing safety case has been cancelled for a subject. |
| Receive the Safety Case Acknowledgment Notification | Site, sponsor | Site users with this permission are notified whenever Safety has either accepted or rejected a case. |
| Receive the Safety Case Could Not be Created Notification | Site, sponsor | Site users with this permission are notified whenever the system has attempted to create a safety case, but has failed, or whenever mandatory questions have not been completed for a case. |
How it works
- specify when the system needs to automatically create and send subject data to Safety.
- indicate what data should be included in the transmission, where the subject data needs to be integrated in Safety.
- assess whether any missing data items should block the creation of this transmission.
- define when to send follow-up cases to Safety.
When a site user enters a subject adverse event, Oracle Clinical One Platform determines, based on study design, if the adverse event should be sent to Safety. If so, Oracle Clinical One Platform automatically creates a new case and associates data from other subject forms with the case. The system then sends the case to Safety.
The safety case is sent to Safety in near real-time via Oracle Clinical One Digital Gateway. According to the schedule configured for the integration, the system also sends follow-up cases to Safety.
Details for sponsor users
As a sponsor user, you can now enable the integration of adverse event data at the study level. You do this on the General tab in the study settings by turning the new Integrate with Safety System toggle on or off.
Once you have enabled the study-level setting, study designers can configure forms that trigger the creation of safety cases, as well as other forms that are sent to Safety along with the adverse event data.
As a sponsor user, you can also receive the notifications related to safety cases, provided that you have the appropriate permissions.
To begin integrating data to Safety, a Oracle Clinical One Digital Gateway integration must be configured. For more information, reach out to your Oracle point of contact.
You can find additional information in the Sponsor and CRO User Guide, as well as the Digital Gateway User Guide after the Release Assessment Environment (RAE) upgrade.
Impact on library management
- The following safety configuration properties can be copied from a study to a library, as well as from a library to a study:
- forms with the E2B(R3) data element mappings, as configured by study designers.
- the Trigger Safety Case rule and the forms associated with adverse event data collection.
- the configuration of questions as mandatory for the creation of a safety case.
- the property of a question to trigger a follow-up case.
- Safety cases cannot be created in libraries.
Details for study designers
- Create your adverse event form and specify which item initiates the safety case to be integrated with Safety. This is done by adding a Trigger Safety Case rule to one or more questions, which can only be checkbox, radio button, or drop-down type questions.
- Indicate which forms should be included in the safety case by turning on the Include in Safety Case Data toggle, which can be found on the Details sidebar.
- Mark one or more questions as Required for Case Creation by enabling the toggle on the Advanced sidebar. Forms with this toggle enabled are mandatory for the transmission of the case to Safety. This means that adverse event data isn't sent to Safety unless site users answer these questions. You can mark forms as mandatory across multiple visits. Only questions whose data is considered obligatory in Safety can be marked as mandatory. When designing the forms which need to be integrated to Safety, you must also map any questions that are to be transmitted to Safety to the E2B(R3) standard, meaning that the input received by these questions must comply with the E2B(R3) format. To do so, select the appropriate E2B(R3) mapping for your question from the Advanced sidebar.
Caution:
Unmapped questions are not integrated with Safety. - You can add E2B(R3)-specific codelists to questions once an E2B(R3) data element is mapped; this is not mandatory. Non-E2B(R3) codelists can be used too.
- Set up a follow-up safety case to be triggered whenever the data for a question is updated. To this end, enable the Trigger a Follow-up Case toggle on the Advanced sidebar.
You can find additional information in the Study Designer User Guide after the RAE upgrade.
Details for site users
Your responsibilities include monitoring existing safety cases, filling in any gaps in adverse event data, and submitting and resubmitting cases.
- Not submitted: These are cases that have been created but have not yet been submitted to Oracle Clinical One Digital Gateway. Cases with this status may have mandatory questions that have not been completed. Follow-up cases may also have this status if the data pertaining to a question that triggered the follow-up has changed.
- Submitted: These are cases that have been submitted to Oracle Clinical One Digital Gateway.
- Accepted: This indicates that a case has been accepted by Safety.
- Rejected: This indicates that a case has been rejected by the recipient safety system. Cases with this status may or may not include a comment explaining the justification for the rejection.
- Transfer failed: This indicates that an internal error has occurred, and the case has not reached Oracle Clinical One Digital Gateway. If errors are encountered during the submission process, site users can address the error and resubmit the case.
- Canceled: These are cases that have been manually canceled by site users. If required, cases with this status can be re-opened and the form selections made for the initial case are preserved.
- Dismissed: When a site user manually dismisses cases with a status of Not Submitted, the system automatically converts them to this status. If necessary, site users can reopen them.
The Queries page reflects any safety case that requires your attention. As part of these automatically generated queries, you can see what has prevented the transmission of the case to Safety. For example, failure to complete a required item prevents the transmission of a case, which results in the creation of a query. You can easily navigate to the question from the query’s Details panel. Once you have made the necessary changes, the query automatically closes.
Note:
New data added for a subject is not automatically added to an existing case. A site user must manually add it.You should also know that whenever the system triggers the creation of a new case that is to be sent to Oracle Safety One Argus, all data entered for that subject using E2B(R3) mapped forms will be included in the case.
You can find additional information in the Site User Guide after the RAE upgrade.
Impact on reports
| Report | Type of change | Description |
|---|---|---|
| Study Design report | New section and new filter, as well as changes to an existing column | The following changes have been made to this report:
|
| Annotated Case Report Forms | Changed content of existing column | The new safety-related properties of questions are reflected in a new Advanced column:
|
Already working in a live study?
As a sponsor user, as soon as this release is available, you can reach out to your Oracle point of contact to configure the integration with Oracle Clinical One Digital Gateway. Once the integration is configured, you can enable the transmission of adverse event data on a study level for existing studies.
As a study designer, you should bear in mind the following:- The Advanced Study Versioning (ASV) of a safety case triggering rule is supported.
- Changes to E2B(R3) mapping are supported with ASV changes.
Caution:
If mapping has changed, previously integrated cases will not be updated. This new mapping will only be reflected in new or updated cases.
Parent topic: Integrations