Site items return
A site is the location where the subject treatment and item dispensation occurs. In the course of a clinical trial, the need may arise to return dispensing items from a study site to the depot. In IWRS, you can return any available items to the respective depot so they can be reused elsewhere, or you can return items for destruction if they have been, for example, damaged or else.
Some of the reasons for returning available items include the excess inventory if the site has dispensed more items than are required for a specific period or patient cohort; protocol amendments that imply adjustments to the treatment regimen, dosage, or eligibility criteria; subject discontinuation or withdrawal that results into the need to return items associated with those patients.
Some of the reasons for returning items for destruction include expired products that are no longer suitable for use and cannot be administered to subjects; items may become damaged or compromised during storage or transportation, rendering them unsuitable for use; in the event of study termination, the remaining items must be returned to the depot for destruction as it is a part of the overall study closure process.
Return shipments can also be created automatically by the system when the site rejects their supply shipment and all the items must be returned to the supplier.
In the IWRS application, the site item return can be handled within the Return tab during the site management process.
