Clinical Supply Manager - Unblinded

View the permissions included in the Clinical Supply Manager - Unblinded template study role. This template study role is of Sponsor 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.
A user who is assigned this template study role can also manage tasks related to integrations between Oracle Clinical One Platform and the following suppliers:
  • Almac Global Depot Network
  • Fisher Clinical Services
  • SmartSupplies PMD
  • Catalent Clinical Supply Services

Table 6-4 Permissions included in the Clinical Supply Manager - Unblinded template study role

Category Assigned permissions

Clinical Data Collection

  • Edit Classified Subject Data Only
  • View Blinded Dispensation Details with Calculated Doses [Site]
  • View Blinded Dispensation Details without Calculated Doses [Site]
  • View Classified Subject Data Only
  • View Form Data for Subjects

Data Extract

  • Run the Subject Data Extract [Unblind]

Inventory Management

  • Blinded Depot User
  • Create Manual Shipments
  • Create Manual Shipments (Unblinded) [Unblind]
  • Create Shipments to Depots [Unblind]
  • Create and Manage Dispensation Exceptions
  • Receive New Shipments at the Depot
  • Receive and Reconcile Shipments at the Depot
  • Release Shipments from Quarantine
  • Update Supplies after Design Approval [Unblind]
  • Update the Shipment Order Form
  • View Shipments to Sites
  • View Site Inventory

Notifications

  • Receive Notification of Depot Shipments [Unblind]
  • Receive Notification of Shipments
  • Receive Notification of Shipments Not Received for All Sites
  • Receive Site has been Updated Notification
  • Receive the Quarantined Depot Shipment Notification
  • Receive the Quarantined Site Shipment Notification
  • Receive the Released from Quarantine Notification (Depot)
  • Receive the Study Limits Notifications
  • Receive the Subject Rollover Notification
  • Receive the Unblinded Dispensation Notification [Unblind]
  • Receive the Unblinded Dose Hold Notification [Unblind]
  • Receive the Unblinded Kit Misallocation Notification [Unblind]
  • Receive the Unscheduled Visit Notification

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Inventory Report
  • Run the Blinded Kits Dataset
  • Run the Blinded Randomization Report
  • Run the Blinded Subject Events Dataset
  • Run the Enrollment Report
  • Run the Kit Dispensation Report
  • Run the Kit Reconciliation Report
  • Run the Order Summary Report
  • Run the Site and Depot Report
  • Run the Study Codelist Dataset
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Subject Data Report
  • Run the Subject Dataset
  • Run the Subject Events Report
  • Run the Subject Form Items Dataset
  • Run the Subject Forms Dataset
  • Run the Subject Visit Report
  • Run the Supply Prediction Report [Unblind]
  • Run the Titration Summary Report
  • Run the Training Report
  • Run the Unblinded Chain of Custody Report [Unblind]
  • Run the Unblinded Inventory Report [Unblind]
  • Run the Unblinded Kits Dataset [Unblind]
  • Run the Unblinded Subject Events Dataset [Unblind]
  • Run the Unblinded Subject Visit Schedule Report [Unblind]
  • Run the Unblinded Titration Summary Report [Unblind]
  • Run the User Assignment Report
  • Schedule Reports to Run

Study Management

  • Perform Source Data Verification and Reconcile Inventory

Study Setup

  • Assign a Resupply Strategy to a Depot
  • Assign a Resupply Strategy to a Site
  • Assign a Study Version to a Site
  • Create and Manage Depots
  • Create and Manage Lots [Unblind]
  • Create and Manage Sites
  • Edit Regions
  • Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies [Unblind]
  • Upload and Generate Inventory Lists [Unblind]
  • View Depots
  • View Role Assignments for Study Users
  • View Sites
  • View Study Design
  • View Study Settings
  • View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies [Unblind]

Unblinded Study Management

  • Manage Study Inventory for Unblinded Users [Unblind]
  • Update Inventory Lists [Unblind]

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