Use barcodes for creating kit lists and confirming dispensation

Clinical supply managers can set a study to use barcodes and let site users confirm dispensation.

What are the benefits?

First of all, including barcodes in your kit lists helps you improve the quality of data related to supplies and dispensation. Additionally, enabling confirmation of kit dispensation ensures subjects' safety with the validation of kits during the dispensation process.

Details for clinical supply managers

If your study protocol allows barcodes to be included in kit lists, then you may be able to either upload or create kit lists that contain 1D or 2D barcodes (such as QR codes). Moreover, you can now configure your study in order for site users to confirm the dispensation of kits to subjects.

Enable site users to confirm dispensation of kits to subjects

There's a new setting on the Supply Settings tab that lets you enable site users to confirm the dispensation of kits to subjects. By default, this setting is set to No.

Figure 18-55 New setting for clinical supply managers

Setting is a radio button.
Barcodes can be included in uploaded or generated kit lists in the system
  • When you upload a kit list that contains barcodes, you can map headers for both 1D barcodes and 2D barcodes (such as QR codes). A 1D bar code is a regular string of numbers that can be created based on kit numbers . A 2D barcode can be a QR code and it typically appears as a much longer string of numbers in the system.
  • When you generate a kit list in the system, you can choose to generate 1D barcodes, as well. Additionally, you can choose whether bar codes can use kit numbers or the system should generate new numbers for barcodes.

Figure 18-56 How a clinical supply manager uploads or generates a kit list with bar codes

Kit list is a file.

You now get a better view of kits for both the entire study and at a site level

On the Supplies tab, you can now access two separate inventories for a study and a site.

The Site Inventory tab is where you're able to see kits at a site from a blinded site user's perspective, regardless of whether kit reconciliation is required or not in the study. This gives you a more granular view of a site's inventory. On this tab you can:
  • Search kits by their number.
  • See which kits are verified or not by the CRA in the new CRA verified column. For each kit, you can also click the check mark in this column, if the kit is verified by the CRA
  • See which of the kits' dispensation is confirmed in the new Dispensation Confirmed column.
  • Update a blinded kit's status

Figure 18-57 Site Inventory tab

Site Inventory tab
On the Study Inventory tab you can:
  • See the generated kit lists
  • View or edit a kit's barcode, on the new Barcode pane
  • Make updates to both blinded and unblinded kits in a study

Details for site users

If dispensation confirmation is enabled in your study, you can either confirm the dispensation of multiple kits at once or confirm the dispensation of one single kit at a time:
  • On the Dispense Kits wizard: You can confirm the dispensation of multiple kits right after you've dispensed them to a subject in the system.

    Figure 18-58 How site users confirm dispensation on the Dispense Kits wizard

    Confirm dispensation on the Dispense Kits wizard
  • On the Confirm Dispensation window: You can confirm the dispensation of kits later, too. You can select a subject and either confirm the dispensation of all kits at once or confirm the dispensation of kits individually. In both cases, the Confirm Dispensation pop-up appears where you can confirm the dispensation of your kits by either scanning their bar codes or manually typing them.

    Figure 18-59 How site users confirm dispensation on the Confirm Dispensation pop-up

    Confirm Dispensation pop-up

Additionally, you can now replace, reconcile or confirm a subject's kit from the same place, with the new menu icon displayed on the right next to each kit. A green check mark appears next to each dispensed and confirmed kit, in the Subject History.

Figure 18-60 How site users see kits that need to be confirmed on the Subject History

Kits that need to be confirmed on the Subject History

Reporting changes

Data on the new setting for dispensation confirmation can be found in the Study Design report.

Already working in a live study?

As a clinical supply manager, you can enable kit dispensation confirmation and include barcodes in your study as soon as the system upgrade is complete. As a site user, you can start confirming the dispensation of kits as soon as the updated study is approved and live.