Summary

This article covers how to add randomization and inventory roles.

Table of Contents


Add Randomization Roles

The following tables list all the permissions for Randomization. Enter each permission into the Roles worksheet. Then select the Roles that should have these permissions by placing an ‘X’ in the appropriate columns. To view an example of how each permission is used in the system, select the permission’s Action name.

Refer to the emergency unblinding section for more information regarding additional unblinding roles.

The standard set of Roles can be found in the Trial Design manual.

Actions
Actions Required
Screens Required
Randomization – Check CriteriacheckActivationCriteriaactivateRecord
Randomization – ActivateactivateRecord,checkActivationCriteriaactivateRecord
Randomization – Populate SchedulepopulateStrata
Randomization – DeactivatedeactivateRecord
Randomization – View SchedulescheduleManager
Randomization – Activate By SlotactivateBySlotscheduleManager
Randomization – Remove/Restore SlotremoveSlot,restoreSlotscheduleManager
Randomization – Edit SloteditSlotscheduleManager
Randomization – Treatment ReportsviewTreatmentDistribution, viewTreatmentStratumDistribution, viewTreatmentFactorLevelDistribution
Randomization – Export Randomization SchedulescheduleManager,exportSchedule
Randomization Unblinded – Import ScheduleimportStrata
Randomization Unblinded – Create SlotcreateSlot
View BlindviewBlind

The following description provides further detail about specific permissions that may not be clear from the above.

View Blind

Those with this permission can view blinded information related to randomization.

Add Inventory Roles

The following tables list all the permissions related to Inventory. Enter each of the permissions into the Roles worksheet. Then select the Roles that should have these permissions by placing an ‘X’ in the appropriate columns. To view an example of how each permission is used in the system, select the permission’s Action name.

Actions
Actions Required
Screens Required
Inventory – Assign DrugdrugAssignment,drugAssignmentManager
Inventory – Replace AssignmentreplaceAssignment
Inventory – Cancel AssignmentcancelAssignment
Inventory – View Dose RecordsdrugAssignmentManager,viewDoseRecords
Inventory – Drug Assignment ManagerdrugAssignmentManager
Inventory – Drug Container ManagerdrugContainerManager
Inventory – Shipment ManagershipmentManager
Inventory – View ShipmentviewShipment
Inventory – Cancel ShipmentcancelShipment
Inventory – Confirm ShipmentconfirmShipment
Inventory – Populate InventorypopulateInventory
Inventory – Initiate ShipmentinitiateShipment
Inventory – Remove/Restore ContainerrestoreContainer,removeContainerdrugContainerManager
Inventory – Change Container StatuschangeContainerStatusdrugContainerManager
Inventory – Change Expiration DatechangeExpirationDatedrugContainerManager
Inventory – Edit Drug ContainereditDrugContainerdrugContainerManager
Inventory – Create ShipmentcreateShipmentdrugContainerManager
Inventory – Assign By ContainerassignByContainerdrugContainerManager
Inventory – Remove/Restore ShipmentremoveShipment,restoreShipmentshipmentManager
Inventory – Edit ShipmenteditShipmentshipmentManager
Inventory – Edit Shipment TrackingeditShipmentshipmentManager
Inventory – View Global ContainersviewGlobalContainers
Inventory – View Global ShipmentsviewGlobalShipments
Inventory Unblinded – Import InventoryimportInventory
Inventory – Edit Assignment DescriptioneditDescription


Note: The DataArchitect Template shows the editShipmentTracking action, but this permission is not working.  To Edit Shipment Tracking the editShipment permission is needed.


Deprecated Inventory Permissions

The below rows are included in the DataArchitect Template, but reference screens that have been deprecated. They have been replaced by options referenced in the table above.

Actions
Actions Required
Screens Required
Confirm Inventory ShipmentsupdateInventory
Check InventoryviewInventory

The following description provides further detail about specific permissions that may not be clear from the above.

View Global Permissions

The two View Global permissions allow those with such permissions to see all related data across the study rather than for just a single site. Global Permissions are required to see Shipping Depots and other sites in the network. Without Global Permissions the user will only see the details (containers, shipments, etc.) from the site they have access to. For example, a Data Manager with the View Global Shipments permission could view the shipments for every site within a study.


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