TrialKit and Clinical Studio have the ability to track any number of products in a single study. Additionally, it can auto-assign items from inventory based on randomization allocations. This is complete IWRS capability. Read more here on how to setup and manage this function.
The system is able to do this by creating a workflow and assigning roles to each level in the workflow. The workflow defines a step in the process of distributing products to sites and assigning those products to patients. A typical workflow may look like this:
|Workflow Level||Role||Site Specific|
The last level in the workflow assigns products to the patient.
There are two workflow level types; Site Specific and Non-Site Specific. The system identifies this by using the role type that is assigned to the workflow. For example, the manufacturing role is an administrative role with a very low role hierarchy. The data coordinator is a site role. The system knows the role type the workflow level type.
Each workflow level has two dispositions. They are as follows:
- Awaiting Acceptance to inventory. When a product is moved from one workflow level to another, it must be accepted into inventory by the target level. The product is considered in transit prior to being accepted into inventory.
- In Local Inventory. After a product is accepted it is stored in the local inventory of the workflow until it is moved on or assigned to a patient.
Each study can track as many different products as is necessary. There is no limit on the number of products that can be tracked. Where a product exists at any point in time is a combination of the product's status (workflow level) and the product's disposition. Several reports are available that allow the user's to get any or all products current status/disposition at any one time.
The barcode reader on the mobile TrialKit app is fully integrated into the Product Tracking system and greatly enhances the experience. Products can be initially scanned into the inventory of the first workflow level and scanned into or out of each subsequent workflow level. When assigning a product to a patient, the product must be selected in a select control.
The below articles are linked to walk you through setting up the product tracking system:
1. Define a unique inventory list and its parameters
2. Define a workflow which items in the inventory must follow
3. Import an Inventory list, scan items into the master inventory list, or a combination of the two
4. Tie the inventory to randomization allocations in the study (optional)
5. Using the Inventory System