Roles for blinded study users

Learn more about the roles and responsibilities of a blinded study user, such as a CRA or a data manager.

About these study roles

• Modes: You can assign these study roles in Testing, Training, and Production mode.
• Users: You typically assign these study roles to a blinded study team member, such as a Clinical Research Associate (CRA), data manager, medical monitor, or blinded depot user.
• Type: These study roles fall under the Sponsor category.

Blinded study team member roles and their responsibilities

Role	Responsibilities	Notes
Adjudicator	View, edit, and manage classified subject data.	None.
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.	The Blinded Depot User role hides full details and descriptions of kits to protect blinding. However, the study role provides access to view the kit numbers for all blinded, unblinded, and unblinded pharmacist kits when assigned. 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	Although a Clinical Research Associate (CRA) is typically a blinded study team member, a CRA can also be unblinded when they need to review Unblinded Pharmacist kits and 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.	None.
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.	None.
Site Administrator	Run reports and perform study setup tasks. Create, view, and manage depots.	None.
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.	None.