Summary

This article covers the various managers and the objectives of each.

Table of Contents

• Shipment Manager
  • Objectives
• Drug Container Manager
  • Objectives
• Drug Assignment Manager
  • Objectives
  • Cancel or Replace Assignment
  • View Dose Records
  • Edit Description Field for a Drug Assignment
• Schedule Manager
  • Objectives
  • Edit Slot
  • Activate a Subject
  • Delete Slot
  • Restore Deleted Items
  • View Minimization Seed Value

Aside from viewing drug assignments in the Drug Assignment Manager, these tasks are generally completed by an unblinded member of the study support team.

Shipment Manager

Objectives

• Delete a Shipment
• Edit a Shipment
• Update a Shipment’s Progress
• Edit a Shipment’s Tracking Information

1. Select the ‘Shipments’ tab at the top of the screen.
2. Click the checkbox that corresponds to the shipment that you want to change.
3. In the Actions drop down menu select the appropriate action.
4. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
5. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to a confirmation page.
6. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
7. Complete the form.
8. Click the ‘OK’ button to complete the action or ‘Cancel’ to cancel the action.
   • You will return to the Shipment Manager.

Note: Deleted items can also be restored.

Drug Container Manager

Objectives

• Delete a Drug Container
• Change a Drug Container Status
• Change an Expiration Date
• Edit a Container
• Create a Shipment
• Assign a Drug

1. Select the ‘Drug Containers’ tab at the top of the screen.
2. Click the checkbox that corresponds to the drug container that you want to change.
3. In the Choose an Action drop down menu select the appropriate action.
4. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
5. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to a confirmation page.
6. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
7. Complete the form.
8. Click the ‘OK’ button to complete the action or ‘Cancel’ to cancel the action.
   • You will return to the Drug Container Manager. 

Note: Creating a shipment as described above from within Drug Container Manager does not trigger a shipmentRequest email.

Note: Deleted items can also be restored.

Drug Assignment Manager

Objectives

• Cancel or Replace Assignment
• View Dose Records
• Edit Description Field for a Drug Assignment

Cancel or Replace Assignment

1. Select the ‘Drug Assignments’ tab at the top of the screen.
2. Click the checkbox that corresponds to the drug assignment that you want to change.
3. In the Choose an Action drop down menu select the appropriate action.
4. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
5. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to a confirmation page.
6. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
7. Complete the form.
8. Click the ‘OK’ button to complete the action or ‘Cancel’ to cancel the action.
   • You will return to the Drug Assignment Manager.

Note: Deleted items can also be restored.

View Dose Records

1. In the Drug Assignment Manager, select the Drug Assignment ID that you want to view.
   • A new window or tab will open displaying dose information related to the drug assignment.
2. Click the ‘Close’ button to close the new window or tab.

Edit Description Field for a Drug Assignment

1. In the Drug Assignment Manager, click the checkboxes next to the appropriate drug assignments.
2. In the Actions drop down menu, select ‘Edit Description.’
3. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to the ‘Edit Drug Assignment Description’ page.
5. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
6. Enter a Description in the ‘Edit Description’ textbox.
7. Enter a reason for change.
8. Click the ‘Ok’ button to complete the action or ‘Cancel’ to cancel the action.

Schedule Manager

Objectives

• Edit Slot
• Activate a Subject
• Delete Slot
• Restore Deleted Items

Edit Slot

1. In the Schedule Manager select the Slot ID that you want to edit.
   • A new window will open displaying the slot’s information and editable fields.
2. Edit the slot’s information
3. Click the ‘Update’ button to save the changes or ‘Close’ to cancel the action.

Activate a Subject

By activating a subject through the Schedule manager, a subject can be forced into a specific slot.

1. On the Study Site homepage, select ‘Schedule Manager’ in the Randomization actions menu.
2. Click the checkbox that corresponds to the slot that you want to use for activation.
3. In the Choose an Action drop down menu select ‘Activate.’

Note: A second drop box will appear to allow the selection of ‘Checked Rows’ or ‘All Filtered Rows’. Only one slot can be activated at one time.

4. Click the ‘Go’ button to the right of the second dropdown menu.
5. Complete the ‘Activate By Selecting Slot’ form.

Note: If you choose not to assign a drug during activation, you will need to assign the drug manually.

6. Click the ‘Activate’ button to complete the action or ‘Cancel’ to cancel the action.
   • If you click the ‘Activate’ button and the subject is ready for activation, the system will inform you of a successful activation. If the subject is not ready for activation, the system will indicate which criteria have not been met.
7. Click the ‘OK’ button to return to the Drug Assignment Manager.

Delete Slot

It is possible to delete a slot from a randomization schedule.

Note: This action should only be taken by members of the study team experienced with the Randomization & Trial Supply Management product and only with the appropriate study approvals.

1. Select the ‘Schedule’ tab at the top of the screen.
2. Click the checkbox that corresponds to the slot that you want to delete.
3. In the Choose an Action drop down menu select ‘Delete Checked.’
4. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
5. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to the ‘Confirm Delete Slot’ page.
6. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
7. Enter a reason for deleting the slot(s).
8. Click the ‘OK’ button confirm the action or ‘Cancel’ to cancel the action.
   • You will return to the Drug Assignment Manager.

Restore Deleted Items

After deleting an item in any of the managers, it is possible to restore it.

1. In the manager select ‘Deleted’ in the ‘Deleted Status’ dropdown menu in the filter section. Click the ‘Search’ button to populate results.
2. 
   
3. Click the checkbox that corresponds to the item that you want to restore.
4. In the Choose an Action drop down menu select ‘Restore Checked.’
5. A second dropdown menu will appear to the right. Select ‘Checked Rows or ‘All Filtered Rows’.
6. Click the ‘Go!’ button to the right of the second dropdown menu.
   • You will be redirected to the ‘Confirm Restore Slot’ page.
7. If ‘All Filtered Rows’ is chosen, confirm that the filtered criteria is correct.
8. Enter a reason for restoring the slot(s).
9. Click the ‘OK’ button to confirm the action or ‘Cancel’ to cancel the action.
10. To view all of the active items again, select ‘Active’ in the ‘Deleted Status’ drop down menu and click the ‘Search’ button to populate the results. 

View Minimization Seed Value

If the trial is configured to use the Minimization Algorithm and the algorithm encounters treatments with tied imbalance scores, the algorithm randomly selects one of the possible treatments. The seed value associated with this random selection can be used to regenerate this schedule. This section describes how to view that seed value.

Note: Only those with the viewBlind permission can view the Seed value.

1. In Schedule Manager, hover the mouse over the green ‘Actions’ menu and select ‘CSV’ or ‘Excel’ to export the schedule.
2. Edit the output settings.
3. Click the ‘Download File’ button.
4. After opening the export file, locate the ‘Seed’ column to view the seed value.

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