This step-by-step guide will help you understand how to successfully cancel an order when using an Interactive Response Technology (IRT)system
When canceling shipments for a study using an IRT system for drug management, make sure you know how IP orders are processed. IRT systems generally create drug requests under three conditions: upon initial site activation or screening activity, in response to drug need at a site with active subjects or due to a manual order.
Investigational drugs are typically sent to the site for the first time via a drug order that is created as a result of site activation or subject screening. Initial shipment quantity is a unique setting in most IRT systems. This is especially important to recognize should an initial drug shipment be canceled and a subsequent order needs to be requested.
Drug orders created as a result of drug need at a site normally occur after site activation and include quantities based on trigger/re-supply/buffer levels or projected need. Therefore, the quantity of drug in a given order will vary greatly depending on site activity.
Drug orders that result from a manual order inputted into the system are created with custom quantities specified by the user. These Drug shipments may be used as a bolus to a site, or to support a site with supplies in a pending temperature excursion.
How to cancel shipments using IRT
All IRT systems will have an option to cancel IRT Drug shipments and return the supplies to the depot. The key is knowing when to use the cancellation option and when to pick up the phone.
Most, if not all, IRT systems do not integrate shipment cancellation with the depot. So even though you’ve clicked the cancel option for your shipment, the depot does not get the message. To successfully cancel the IRT Drug shipment, you need to start by contacting your clinical supply manager or depot contact. Be sure to obtain confirmation that the cancellation is possible. If the IRT Drug shipment has left the depot, it may be beyond the point of no return and unable to be cancelled. If the depot confirms the IRT Drug shipment can be canceled, then it can also be canceled in the IRT. The IRT cancellation should be the last action you take.
The consequences of not contacting the depot first
If you do not contact the depot first and only cancel the order in the IRT system, the logical inventory in the IRT and the physical inventory at the depot will be out of sync. The IRT will go on to request kits from the canceled shipment for other orders to other sites. This will cause errors in the depot’s inventory management system, and possibly cause supply disruptions at the site level. You’ll also have a lot more work on your hands. In this case, your best bet is to perform an IRT data change to un-cancel the order and allow it to be confirmed at site. However, if the automated IRT drug management runs before the error is discovered, you may find yourself canceling additional IRT Drug shipments that have kits from the original cancelled order. You’ll also go back and forth quite a bit with the depot.
Re-generating shipments to sites that have had a cancellation
Often you’ll be asked to cancel an order and re-generate it with kits from a different quantity or batch. When re-generating an order, be sure you know what quantity to send. Is this for an initial order, a re-supply order or do you need to re-generate with a custom quantity within the IRT? It’s always better to ask questions than to find yourself canceling a second order or group of orders.
To summarize, to effectively cancel an IRT Drug shipment, cancel the depot as soon as possible. Then, once you are sure the drug is no longer on the move, cancel the order in the IRT system. Finally, if you are requested to re-generate an order, be sure of the quantity and the specifics needed for successful re-generation of the Drug shipment in the IRT system.