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Sponsor - Coggle Diagram
Sponsor
Clinical
Operations
Site
Roles
Principal Investigator (PI)
Site user
Pharmacologist
Management/Permissions
Status ACTIVE
Shipment is triggered
Site received shipment
Enter Shipment #
All Kits are available
Functions
Receive shipment
Unblinded receipt of shipment
Mark inventory as lost or damaged
Enter temperature Excursion
Site Ordering
Perform Site Accountability
Perform Destruction
Perform return to depot
Subject
Visits
Screening
(Demographics)
Screen Fail
Re-screen
Screened
Randomization
(Enrolled)
Drug arm assigned
Kit # dispensed
Clinical
Supplies
Inventory Management
Depot Manager
Functions
Receive shipment at depot for destruction
Dispatch shipment
Receive shipment at depot
Unblinded receipt of shipment at depot
Mark inventory at site as lost or damaged
Enter temperature Excursion at Depot
Supply Manager
Functions
Create shipment to site
Create shipment to depot
Dispatch shipment
Receive shipment at depot
Adding a lot
Add a sublot
Lot approval and release
Adding and updating country approval for a lot
Quarantine or Reject a lot
Manage a Temperature Excursion at site
Manually trigger re-supply run
Mark inventory at site as lost or damaged
Confirm/update depot shipment request
Release batch from quarantine
Mark Depot inventory lost or damaged
Enter temperature Excursion at Depot
Biostatics
Randomization Management
CRA/CRO
Functions
Perform Site Accountability
Manage Randomization
(Remove bias)
Ensure that unblinded
Site ordering
Perform distruction