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, or medical monitor.
  • Type: These study roles fall under the Sponsor category.

Blinded study team member roles and their responsibilities

Role Responsibilities Notes

Adjudicator

For the template role description, see Adjudicator.

  • View, edit, and manage classified subject data.

None.

Clinical Research Associate (CRA)

For the template role description, see 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

For the template role description, see 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

For the template role description, see 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

For the template role description, see Site Administrator.

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

None.

Study manager

For the template role description, see 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.