Inventory Management
Inventory and trial supply - (also referred to as IRT or RTSM) is a function of TrialKit built right in for managing investigational product use within the study.
This is incredibly helpful when study subjects are receiving a specific product, device, or drug at any point during studies. Among its various functions, It primarily allows sites to directly assign items on eCRFs from their local inventory, and it can be linked to randomization arms for automated product assignments.
Inventory Roles and Permissions
At a minimum, for most scenarios, two user roles need access to Inventory:
The Inventory Administrator
The site user who accepts items into the site’s inventory and assigns items to participants
Optionally, another user role can give visibility of the entire inventory without the ability to perform any actions within it.
This is all handled, like all aspects of the system, through role security.
Here is an example of the role permissions commonly granted to a site level role:
Anyone having anything to do with inventory, at the very least, will need to be granted access to inventory management via the study role security settings.
Defining Inventories and CRF Attributes
Step 1:
By default, the Inventory Management pages are disabled and need to be made available through Role Security. This can be done by anyone, such as a study administrator with access to do so. The applications to enable are Inventory Administration and Inventory Management.
Step 2:
Enable the inventory system functionality in the Study configuration.
Step 3:
Import the Inventory Configuration form into your Form Builder from the Public Form Library titled "Inventory Forms." The template contains the appropriate naming conventions required, so is easier to start from rather than creating from a blank slate.
From the study form builder, click on Import Form
Select Inventory Forms from the library drop-down field.
Select Inventory Configuration form. Note, this is a study-level form that will be filled out study forms by the Inventory Administrator.
Click on Import Checked Forms to bring them into your form study form builder.
Step 4:
Open Study Related forms and fill out the details of the first inventory you will be using. A new form can be filled out for independent inventory lists used in the same study.
See the annotation descriptions below the image for more detail.
Name of the inventory list
Possible reasons for rejection (field name IC_REJECTION_REASON in the form builder).
IMPORTANT: The choices here must be in the format "X. Reason" - where X is any coded number value, period, single space, reason text. This is how the system will know which choices to display when a site is rejecting an item they received.
A floor level can be set (Field name = ic_ceiling) and a ceiling level can be set (field name = ic_floor). This is how the system will be able to track when (floor level) to notify the appropriate email regarding a needed re-order of a specific type of product, and how many need to be ordered (ceiling level).
The floor and the ceiling levels are for each type of product as defined in column two of the main source file mapped in step 4.2 above. If randomization is not tied to inventory, then all items are considered a single type.
Add a row for each column in the inventory source file. This file will be uploaded in the next step.
The second column of the import file must be a number value to correspond with the type of each item in the list. This can all be one value in the source file if it’s not needed for use, but it’s still required.
Naming rules for column headers:
In general the column names are flexible since they are mapped as described above. However there are some names reserved that cannot be used:
Type
ID
Instead, use terms like “item_type” or “item_id” to avoid those reserved terms.
The second column comes in most important when the inventory needs to be auto-assigned based on randomization allocation. The type value used in the source file must correspond to the randomization allocation value defined in the randomization schedule.
This is how the system will know which items from the inventory list are applicable to certain randomization-based allocations. For example, if the randomization schedule has a "2" for subjects getting the placebo drug, the placebo items in the inventory list should also have a "2" in the Type column of the inventory file.
It suggested to also deny view/edit rights to this form for all roles except the user who is managing inventory.
Step 5: Setting up the CRF for assigning inventory items during data entry
If sites will be manually assigning items to subjects in a CRF, configure a subject form for assigning inventory items to subjects. This is done in the Form Builder.
For studies where multiple items from the same inventory list can be assigned to a subject -
use a multi-select field, and assign the special property based on the name of the inventory:
For studies assigning only one item from a given inventory -
Use a dropdown (single-select) field
For both above, do not include any choices in the field. The system will dynamically provide choices automatically on the subject record based on what is available at the corresponding site during the time of data entry.
For studies automatically assigning a single item from a specific inventory list:
Items can be auto-assigned by randomization allocation (IWRS). In that case, add a TEXT field to the form. It's preferable to do that on the same form where randomization allocation is getting triggered from. Nothing needs to be done with that text field. It will be defined in a later step so the system knows which field in the study to populate with an inventory item based on the subject's allocation and items available at the site.
Importing, Configuring, and Overseeing Inventory
Open the page titled Inventory Configuration under the Study menu. This page will only be available with proper role permissions.
This can also be done on the TrialKit app.
See below the annotated image for detailed descriptions of the functions on this page:
1 Define the workflow each item in the inventory will follow. This must be done before an inventory can be uploaded. Read more below this section on how to set up the product workflow.
2. Select the corresponding inventory and upload the inventory file (CSV format only). Be sure the file is set up properly based on how the column names were defined in the Defining Inventory section above.
As the study progresses, new items can be added to the CSV file and then uploaded to the same location. The system will append those new items onto the existing master inventory list without affecting pre-existing items.
Using the TrialKit mobile app, items can also be individually scanned directly into the inventory if they have a barcode. The system will populate the identifier column with the barcode ID automatically and allow the user to fill out any other details which were defined in the import configuration form.
3. OPTIONAL STEP: Relate the inventory to randomization. This allows the system to auto-allocate an item from inventory based on the subject's allocation assignment in the randomization schedule. Read the previous article on how to configure the import file properly if this function is being used. When this method is used, the system will automatically place site activation orders and subsequent site refill orders based on the floor/ceiling levels defined for the corresponding inventory.
4. Define the Type of each item that was imported. This is how the system can display the type meaning in the various inventory reports. See Defining Inventories and CRF Attributes for an explanation of the type.
5. After the inventory has been imported (item 2 above), a page refresh may be needed to populate this table where item types and quantities are displayed for the various possible item statuses. Here's an example:
6. Site Activation
This is how the system will send an email notice to distribution (normally an external/3rd party IP vendor) of items that need to be shipped to the respective site, and a similar notification to the site contact person. This step is only required for initial site activation. All other orders are made automatically by the system as sites hit the floor levels.
7. Inventory Levels by site display similar metrics as item 5, but on a per-site basis, rather than study-wide.
8. Reset Inventory
Only used for testing or UAT purposes when an Administrator would like to reset and clear the inventory completely without losing the configuration. This permission should be disabled when the study is live to prevent accidental reset.
Defining an Inventory workflow
Select the inventory to define/edit the workflow for
Add or edit workflow steps that each item from the inventory will follow. This can be as few or as many steps as necessary. The applicable roles for each step of the workflow is an important factor. Items with site-specific visibility need to SITE type roles, which are defined in Role security.
The name/email/address will be the contact person who receives the shipment notices. This can be a contact that never accesses or utilizes TrialKit. The role defined in the first workflow level will ALSO get copied on these notices.
The site-level workflow contact information is not needed because each site will have its own contact. The site contact is named in the site inventory contact form within the Site Manager under the website host menu. If that form does not exist in your Site Manager, it can easily be imported from the Inventory Forms public form library.
Accessing and Managing Existing Inventories
Once an inventory is configured and uploaded, the inventory list can be managed from the Inventory Management page.
Inventory Management on the Web
The following description corresponds to the annotated image below:
Select the inventory to work with
Choose which workflow level is being conducted
These are the user-defined columns imported into the configuration.
Barcode - Select an item's barcode to display it in the bottom right of the page for scanning, or utilize the barcode label configuration and printing options to have the system automatically generate labels based on the item identifier column. See Printing barcodes below.
Action - Select single or multiple items to perform the action that is currently selected on the right side of the page. In the instance below, no checkboxes are showing because there are no items to accept into inventory currently. Checkboxes will only appear when applicable.
Allocating items to a site - After selecting items in the Action column, choose which site to allocate those items to. Sites will then be able to accept/reject items as they are received. Read on next the Managing Site Inventory section on what sites are able to do after being allocated items from inventory
Inventory Management on the mobile app
From the following screen, from the top down:
Select which inventory to work with. If there’s only one it will be selected already.
Choose which action to perform -
Select Outgoing to release products
Select Incoming to accept products
If outgoing, select the destination point and specific site if the destination is a site
Viewing an item's details
Tap any item in the list from the Inventory manager on the app to see the details for that item:
Scroll down to see the item history.
If the user has permissions to rollback/undo the last item transaction, that can be done from here by tapping the undo icon on the last event:
Deleting Inventory Items
This function can currently be performed only on the mobile application.
To completely remove an item from the inventory list, the item must exist at the first workflow level. For example, if a site needed to send back a damaged item, it needs to be released from the site and accepted at the distribution level. The user performing the delete must also have access to the first workflow level.
To Delete an item, open the “Scan Items to Inventory” screen. swipe from right to left on the item to delete.
Printing Bar Codes (Mobile App Only)
Tap administrative tools icon (Gear)
Tap Inventory and Product Tracking
From the Inventory menu select “Export Barcodes”
On the iOS device, go to the device’s iCloud folder to retrieve the barcodes in PDF format ready for printing
Inventory Audit Report
The inventory, like all other study data, is fully audited by the system. Every item that passes through inventory can be tracked with a recorded history.
The inventory audit report makes it possible to see this information.
Access to the inventory audit is based on the role of the first workflow level in the inventory configuration.
It can be accessed from below the Inventory Management option in the menus:
Once open, each item's history can be viewed or exported to Excel.
Annotation references in image above:
Select which inventory and item to for. All items can also be selected here for exporting.
Export the list to Excel format
Select which site to view product history for
Access the e-mail notification log. This is the log of all emails auto-generated by the inventory management system - such as when sites are notified of a re-fill shipment. These include any attached CSV files which may have gone to the distributor.