Site User

View the permissions included in the Site User template study role. This template study role is of Site type and is available for all studies at your organization.

Note:

You should always copy a template role and begin customizing it within the context of your study. For more information, see About template study roles.

Table 6-12 Permissions included in the Site User template study role

Category Assigned permissions

CRF Submit Access

  • Confirm download of the Archival PDF
  • Download the Archival PDF
  • Run the Archival PDF for your site

Clinical Data Collection

  • Add a Lab to a Site
  • Add and Update Lab Normal Ranges
  • Answer Queries
  • Approve and Sign Assigned Data Only
  • Approve and sign subject data
  • Create and Add Labs to a Site
  • Dispense Kits with Calculated Doses
  • Dispense Kits without Calculated Doses
  • Edit Classified Subject Data Only
  • Edit Form Data for Subjects
  • Edit Visit Dates
  • Randomize Subjects
  • Safety Case Creation (planned for a future release)
  • Safety Case Submit (planned for a future release)
  • Skip Visits
  • Take Action on Connected Devices
  • Unblind the Treatment Arm for a Subject, or Code Break [Unblind]
  • View Blinded Dispensation Details with Calculated Doses
  • View Blinded Dispensation Details without Calculated Doses
  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries

Inventory Management

  • Create Manual Shipments
  • Perform Supplies Reconciliation at Site
  • Receive Shipments and Update Site Inventory
  • View Shipments to Sites
  • View Site Inventory

Notifications

  • Receive Notification of Shipments
  • Receive the Code Break Notification
  • Receive the Dispensation Notification
  • Receive the Randomization Notification
  • Received the Released from Quarantine Notification (Site)
  • Receive the Subject Number Update Notification
  • Receive the Subject Screening Notification
  • Receive the Subject Transferred Notification
  • Receive the Subject Undo Completion Notification
  • Receive the Subject Undo Screen Failure Notification
  • Receive the Subject Undo Withdrawal Notification
  • Receive the Subject Visit Notification
  • Receive the Subject Withdrawal Notification

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Inventory Report
  • Run the Enrollment Report
  • Run the Kit Dispensation Report
  • Run the Kit Reconciliation Report
  • Run the Lab Normal Range Report
  • Run the Order Summary Report
  • Run the Subject Data Report
  • Run the Subject Events Report
  • Run the Subject Query Report
  • Run the Subject Visit Report
  • Run the Titration Summary Report
  • Run the Training Report
  • Run the User Assignment Report

Study Management

  • Create Shipments to DDF
Trial Management

Note: All permissions listed in this category are planned for a future release.

  • Create Trial Management Event Records from Subjects Tab
  • Edit Actions on Trial Management Event Records
  • Edit Trial Management Event Records from Subjects Tab
  • View Actions on Trial Management Event Records
  • View Blinded Trial Management Records
  • View Trial Management Event Records from Subjects Tab
  • View Trial Management Event Records with Actions Assigned to me

For more information on each of these permissions, see Descriptions of permissions in Oracle Clinical One Platform.