New Subject Safety Case dataset in Oracle Clinical One Analytics

You can now report on subject safety cases across studies to monitor submissions, track case status, and support timely Safety reporting.

Details for user administrators and global user managers

The new permission Run the Subject Safety Case Dataset has been added in Clinical One Cloud Service to grant access to the new Subject Safety Case dataset. This permission and dataset are only relevant when integration to safety exists. As a user administrator or global user manager, you can assign this permission to any sponsor user who requires the ability to work with this dataset in Oracle Clinical One Analytics.

This new permission is only added to the View Only for Blinded Supports Users template study role.

Details for sponsor users and pharmacovigilance teams

Review current and historical safety case records, including updates from Clinical One Cloud Service and integrated Safety systems. The core of this dataset are Safety Cases created for the study (either initial or follow-up), including the full audit history of these cases. As part of the audit history, a new record is created for each new case and update to existing case.

The Subject Safety Case dataset exposes Safety case history linked to subjects and sites, including the Clinical One Cloud Service case ID, safety case identifiers, case label, case status, case state, safety comment, submission count, creation timestamp, acceptance timestamp, and audit columns. With these, you can use the Subject Safety Case dataset to:

• Monitor safety case submission and processing status.
• Track initial and follow-up safety cases.
• Identify rejected cases and review associated comments or rejection reasons.
• Monitor timely safety case reporting across sites.
• Review a complete audit history of safety case activity.

Note:

The mapping and actual items mapped and sent to Safety are not included in this dataset. However, these details are included in the Study Design dataset.

You can find additional information about this new dataset and its data elements in the Analytics User Guide after the assessment environment upgrade.

Impact on reports and other datasets

The following table describes this feature's impact to reports:

Report	Description
Study Design dataset	To support reporting on safety cases in Oracle Clinical One Analytics, other new data elements and updates to existing have been introduced to the existing Study Design dataset: Form folder (New) INCLUDE_IN_SAFETY_CASE_DATA Item folder (New) E2B_R3_MAPPING (New) REQUIRED_FOR_CASE_CREATE (New) TRIGGER_FOLLOWUP_CASE (Updated) ACTION_RULES
ODM Metadata extract	The following new attributes are added as Clinical One extensions: co:IncludeInSafetyCase co:E2BR3Mapping co:RequiredForSafetyCaseCreation co:TriggerSafetyFollowUpCase

You can find additional information in the REST API for Clinical One Cloud Service documentation and the Analytics User Guide after the assessment environment upgrade.