Roles for site users

Learn more about the roles and responsibilities of a site user.

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 site user, principal investigator or unblinded pharmacist. If the study role contains the appropriate permissions, you might also assign it to a sponsor or CRO user for validation purposes, in Testing mode.
  • Type: These study roles fall under the Site category. Permissions in these study roles are both blinded and unblinding. Unblinding permissions allow users to view treatment arm details, kit descriptions, or dispense certain types of kits.

Site user roles and their reponsibilities

Role Responsibilities Notes

Blinded site user

  • Randomize subjects and view a site's inventory.
  • Collect data from subjects.
  • Perform kit reconciliation.
  • Performing other data collection and inventory management tasks, such as dispensing kits with calculated doses and creating manual shipments.
  • Generate and manage Oracle CRF Submit archives.

None.

Pharmacy User - Unblinded

  • View collected data at a site.
  • Manage a site's inventory.
  • Run reports.

None.

Principal investigator

  • Approve and sign data.
  • Edit data in order to sign it.
  • Run reports.

None.