Summary
This article covers how to manage inventory and shipments.
Table of Contents
- Populate Inventory
- Locate a Previously Used Seed Value
- Import Inventory With Headers
- Import Inventory Without Headers
- Initiate Shipment
- Confirm or Cancel Shipment
- Confirm a Partial Shipment
- View Shipments
- View Inventory
Except where noted, these tasks are generally completed by an unblinded member of the study support team.
Populate Inventory
If you want to import an inventory file, skip this section.
- On the Study Site homepage, select ‘Populate Inventory’ in the Randomization actions menu.
- Enter the number of items that should be in each container.
Note: The ‘number at which drug labels start incrementing’ should be completed for you based on the current inventory.
- Leave the Randomization Seed blank unless you want to generate an inventory schedule which is identical to a previously created shipment.
- Select a Configuration Type.
Note: For the ‘Configuration Type,’ a permuted block generates inventory blocks that have an equal distribution of treatment types. Choosing ‘regular’ will allow the system to create any amount of any treatment type.
- Enter the number of containers to be contained in the shipment.
- Enter an expiration date.
- Select the packaging company to be populated.
- Click the ‘Populate’ button.
The system will inform you that the inventory was populated successfully.
Locate a Previously Used Seed Value
Randomization seed values are used when populating the inventory with a permuted block. If you want to use a particular Seed Value for shipments that you’ve used before, you can locate the seed value in the Audits. With this seed value, you can create an exact match of a previously created shipment. If you’re not using a particular Seed Value, you can skip this section.
- On the Study Site homepage, select ‘Drug Containers’ option from the Navigation (Hamburger) menu.
- For a container generated with the desired seed value, select ‘View’ under the ‘Audits’ column.
- In the new window or tab that opens, locate the Seed value in the ‘Description’ column.
- Enter this Seed value on the Populate Inventory form.
Import Inventory With Headers
If you already populated the inventory, you can skip this section.
Note: When importing data, assure that there are no blank rows or extra information as this can cause errors. View the Import File Requirements for more information.
- On the Study Site homepage, select ‘Import Inventory’ in the Randomization actions menu.
- Click the ‘Chose File’ button to select a file.
- Indicate that the inventory file has headers by selecting ‘true.’
- Click the ‘Upload File’ button to import the inventory file.
- Review the Inventory.
- If red x’s appear in any of the columns, you may need to configure the import mapping or edit your file.
- Click the ‘Import’ button.
- If no errors occur, the system will notify you that the import was successful.
Import Inventory Without Headers
If you already populated the inventory or imported the inventory with headers, you can skip this section.
Note: Fountayn does not recommend loading files without headers. Doing so can lead to fields being improperly imported.
When importing data, assure that there are no blank rows or extra information as this can cause errors. View the Import File Requirements for more information.
- On the Study Site homepage, select ‘Import Inventory’ in the Randomization actions menu.
- Click the ‘Choose File’ button to select a file.
- Indicate that the inventory file does not have headers by selecting ‘false.’
- Click the ‘Upload File’ button.
- Review the Inventory.
- Click the ‘Configure Import Mapping’ button.
- Using the dropdown boxes, select the column numbers from the inventory file that correspond to the different column names.
- Click the ‘OK’ button.
- Review the Inventory.
- If no errors occur, the columns should no longer be filled with red x’s.
- Click the ‘Import’ button.
- If no errors occur, the system will notify you that the import was successful.
Initiate Shipment
After shipments are populated or imported, they are packaged at the packaging company. To transfer them to the site, you can initiate a shipment. If the trial is configured for automatic drug supply, shipments are initiated automatically when the number of drug units reaches a specified threshold. During both manual and automatic shipment initiation, if the trial is configured to use expiration date deltas for shipments, the system will take drug expiration dates into account and not ship any drug containers that are about to expire.
Note: While most shipment information is completed automatically by the system, the shipment’s tracking number and carrier must be entered manually in the Shipment Manager.
- On the Study Site homepage, select ‘Initiate Shipment’ in the Randomization actions menu.
- Select the locations that request a shipment.
- Select ‘Recommended by system’ to request a shipment of the Recommended Amount. Otherwise, select ‘Enter by user.’
Note: This Recommended Amount is based off of the Restock Level configured by the Trial Designer and the site’s current inventory level.
- If you selected ‘Enter by user,’ enter the number of containers that should be shipped for each drug type.
- Click the ‘Initiate’ button.
- The system will inform you of a successful shipment generation and list the sites receiving the shipment.
Confirm or Cancel Shipment
This task is generally completed by the Coordinator Role.
- On the Study Site homepage, select ‘Confirm’ or ‘Cancel’ in the Confirm Shipment table.
- A new tab or window will open requesting information related to the shipment.
- Complete the form.
Note: The sum of the Received, Missing and Broken columns should be equal to the value in the Total column.
- Click the ‘Continue’ button.
- The system will display a confirmation form for the shipment.
- Click the ‘Submit’ button.
- The system will inform you that the the shipment has been confirmed.
- Click the ‘OK’ button to close the window or tab.
Confirm a Partial Shipment
When a Shipment is originally marked with Missing Containers the shipment becomes a Partial Shipment. A Partial Shipment needs to be confirmed.
- On the Study Site homepage, select ‘Confirm’ in the Confirm Shipment table for the Partial Shipment.
- Complete the Shipment Confirmation Form.
Note: If the Missing Containers have been received, mark the container as received and select “Confirm Drug Kits”
Note: If the Missing Container have not been found, select “Confirm Shipment”. If Confirm Shipment is selected and saved, any changes to the container status will not be recorded. If the status of the container needs to be changed, Confirm Drug Kits must be selected.
- Click the ‘Continue’ button.
- The system will display a confirmation form for the shipment.
- Click the ‘Submit’ button.
- The system will inform you that the the shipment has been confirmed.
- Click the ‘OK’ button to close the window or tab.
View Shipments
- Select the ‘Shipments’ option at the Navigation (Hamburger) menu.
- In the Shipment Manager, you can view information on past and current shipments.
View Inventory
- Select the ‘Drug Containers’ option at the Navigation (Hamburger) menu.
- In the Drug Container Manager, you can view information on drug containers available and in transit.
Need more help?
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