Adjudicator

• View, edit, and manage classified subject data.

Blinded depot user

• View and manage their associated depots' inventory: receive shipments, process shipments, update kit status.
• View and manage shipments only at depots they are assigned to.

Note: The Blinded Depot User role hides full details and descriptions of kits to protect blinding. However, kit numbers for all blinded, unblinded, and unblinded pharmacist kits are displayed.

For a depot user to see the site inventory, they need to be associated to the given sites.

Clinical Research Associate (CRA)

• Review and verify subject-entered data at a site.
• Perform kit reconciliation tasks, such as verifying returned kits and correcting site reconciliation.
• Generate and manage Oracle CRF Submit archives.
• Create custom reports and visualizations in Oracle Clinical One Analytics
• Review Unblinded Pharmacist kits in a site's inventory

Note: Although a CRA is typically a blinded study team member, they can also be unblinded when they need to review Unblinded Pharmacist kits, as long as they are assigned the appropriate permission.

Data Manager

• Review data and run reports.
• Generate and manage Oracle CRF Submit archives.
• Create custom reports and visualizations in Oracle Clinical One Analytics.
• Extract form data in a study.
• Create labs and define lab normal ranges.
• Run reports and view role assignments for study users, view a study's design, and view configured subject settings.

Medical Monitor

• View data in a study.
• Run reports.
• Create custom reports and visualizations in Oracle Clinical One Analytics.
• View, close, and create queries.
• View unblinded kits, role assignments for study users, and a study's design.

Site Administrator

• Run reports and perform study setup tasks.
• Create, view, and manage depots.

Study Manager

• View study data.
• Edit study settings.
• Edit the custom welcome letter content.
• Run reports.
• Perform tasks related to a study's randomization strategy and inventory.
• Generate and manage Oracle CRF Submit archives.
• Create custom reports and visualizations in Oracle Clinical One Analytics.
• Perform other study setup and study management tasks, such as transfering subjects between sites, assigning resupply strategies to sites, study versions, or moving a study's design to Testing or Production.