Outbound subject data integration

You can send subject event data from Clinical One Cloud Service to a third-party Electronic Data Capture (EDC) system, based on the configuration settings you specify in the Clinical One Cloud Service.

Configuration Service details

B92665: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.

For more information see, Oracle Life Sciences Cloud Consulting Professional Services—Service Descriptions and Metrics. If you still have questions, reach out to your Oracle point of contact.

Limitations

Do not apply data flags to any form fields in a Clinical One Cloud Service study, as doing so causes the integration to fail.

Which data can Clinical One Cloud Service share with a third-party EDC system?

All event data is sent to a third-party EDC system based on the intervals defined in the integration schedule.

Type of data	Details
Screen a subject	You choose the data to send from Clinical One Cloud Service to the third-party EDC system. Clinical One Cloud Service sends screening data to the third-party EDC system based on one of two screening events. Integrate data at visit complete: The screening visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Screen button is selected, data is integrated. Integrate data before visit complete: In this scenario, the screening visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Screening, the Screen button is enabled, and when selected, the data is integrated. For more information about this option, see Define required visits. Prerequisites to integrate data before visit complete. You can integrate the visit start date with the screen event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system. The study design must include the Informed Consent Date as a required question in order to integrate it with the screening event. Integration template updates are required. Reach out to your Oracle point of contact for assistance. Note: Screening data can also be integrated following the completion of a rescreen visit. Once completed, Clinical One Cloud Service triggers the screening event, and the corresponding data is integrated. Data from a rescreen visit can be mapped to update initial screening data or as individual scheduled visits. Unscheduled visit mapping is not supported..
Screen fail a subject, undo a subject's screen failure, or update a user's screen failure date and reason	For screen failure, the screen failure date and reason along with any other relevant information related to the screen failure event are sent to the third-party EDC system. You can map these fields to any form you use to collect the screen failure reason. In the third-party EDC system, the subject's status isn't changed. For undo screen failure, the screen failure date is updated to blank in the third-party EDC system. In the third-party EDC system, the subject's status isn't changed. Note: Screen fail data can also be integrated following the completion of a rescreen visit. Once completed, Clinical One Cloud Service triggers the screen fail event, and the corresponding data is integrated. Data from a rescreen visit can be mapped to update previously integrated data or as individual scheduled visits. Unscheduled visit mapping is not supported.
Randomize a subject	You choose the data to send from Clinical One Cloud Service to the third-party EDC system. Note: Data for these events can be sent for subjects who failed screening, as well. Clinical One Cloud Service sends randomization data to the third-party EDC system based on one of two randomization events. Integrate data at visit complete: The randomization visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Randomize button is selected, data is integrated. Integrate data before visit complete: In this scenario, the randomization visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Randomization, the Randomize button is enabled, and when selected, the data is integrated. For more information about this option, see Define required visits. Prerequisites to integrate data before visit complete. You can integrate the visit start date with the randomize event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system. Integration template updates are required. Reach out to your Oracle point of contact for assistance.
Complete a study for a subject, undo a subject's study completion, or update a subject's study completion date	For a subject's study completion event, the completion user-entered date and reason, as well as any other relevant information for a subject's completion event, is sent to the third-party EDC system. For the undo study complete event, the completion date and other details that were sent to the third-party EDC system are cleared. In the third-party EDC system, the subject's status isn't changed. In the Clinical One Cloud Service, if a user manually clears question fields in the resurfaced study completion visit, no job failures occur for this action. Jobs associated with the clear event should succeed in Clinical One Digital Gateway. In the Clinical One Cloud Service, if a user manually updates question fields in the resurfaced study completion visit, this updated value will integrate into third-party EDC system without any jobs failing.
Withdraw a subject, undo a subject's withdrawal, or update a subject's withdrawal date and reason	Data for these events can be sent for subjects who failed screening, as well. For a subject's withdrawal, the withdrawal form in the third-party EDC system is updated with the withdrawal date and reason, as well as any other relevant information. For the undo subject withdrawal event, the completion date and other details that were sent are cleared out in the third-party EDC system. Clinical One Cloud Service retains the information in the withdrawal form. In the Clinical One Cloud Service, if a user manually clears question fields in the resurfaced withdrawal visit, no job failures occur for this action. Jobs associated with the clear event should succeed in Clinical One Digital Gateway. In the Clinical One Cloud Service, if a user manually updates question fields in the resurfaced withdrawal visit, this updated value will integrate into third-party EDC system without any jobs failing.
Code break	If a user performed a code break in Clinical One Cloud Service, Clinical One Cloud Service sends the date and time when the code break was performed to the third-party EDC system.
Kit replacement	Note: If your study uses non-serialized kits and you would like data about non-serialized inventory sent to the third-party EDC system, reach out to your Oracle point of contact. When a kit is replaced, the dispensed kit information is updated with the replacement kit information on the specified form and question in the third-party EDC system.