Clinical Supply Manager - Unblinded

This topic describes the permissions included in the Clinical Supply Manager - Unblinded (template) study role in the application. This template study role is available for all studies in your organization. You can copy the study role and customize it for each individual study you work in.

A user who is assigned this predefined study role template can also manage tasks related to integrations between Oracle Clinical One Platform and:
  • Almac Global Depot Network
  • Fisher Clinical Services
  • SmartSupplies PMD
  • Catalent Clinical Supply Services

Permissions given to a clinical supply manager based on their responsibilities

Note:

To see an overview of all permissions that can be included in study roles, see the View Permissions window in the application.

Table 8-3 Clinical Supply Manager - Unblinded (template) study role

Category Permissions assigned

Clinical Data Collection

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

Data Extract

  • Run the Subject Data Extract

Inventory Management

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

Notifications

  • Receive Notification of Depot Shipments
  • Receive Notification of Shipments
  • Receive Site has been Updated Notification
  • Receive the Study Limits Notifications
  • Receive the Subject Rollover Notification
  • Receive the Unblinded Dispensation Notification
  • Receive the Unblinded Dose Hold Notification
  • Receive the Unblinded Kit Misallocation Notification
  • Receive the Unscheduled Visit Notification

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Inventory 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 Titration Summary Report
  • Run the Training Report
  • Run the Unblinded Chain of Custody Report
  • Run the Unblinded Inventory Report
  • Run the Unblinded Kits Dataset
  • Run the Unblinded Subject Events Dataset
  • Run the Unblinded Subject Visit Schedule Report
  • Run the Unblinded Titration Summary Report
  • 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 (Unblinded)
  • Create and Manage Sites
  • Edit Regions
  • Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies (Unblinded)
  • Upload and Generate Inventory Lists (Unblinded)
  • 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 (Unblinded)

Unblinded Study Management

  • Manage Study Inventory for Unblinded Users
  • Update Inventory Lists (Unblinded)