Resupply configuration described

The purpose of the IRT resupply features is to automate the ordering of drug units to:

Provide sufficient quantity of drug units at the site at all times.
Minimize shipments and shipment costs.

IRT uses a both a projection and buffer resupply strategy for automated supply ordering. You can switch between these strategies when you create a new resupply strategy:

Buffer Resupply—Uses the MinB and MaxB only; patient visits do not affect the orders.
Projection Resupply—Uses the entire resupply model; orders are based on patient visits.

Note: If Buffer Resupply is selected, Trigger Weeks and Resupply Weeks are assumed to be zero. When Trigger Weeks and Resupply Weeks are set to zero, the minimum and maximum buffer quantities act as a simple trigger and resupply without any prediction on subject visits.

The supply ordering algorithm runs according to the frequency set up during study design:

Each time the resupply algorithm runs, IRT calculates each site’s available inventory and then projects the trial supply requirements (based on the subject visit schedule) during the trigger period.
If the site does not have sufficient drug units to cover the need during this time period, IRT orders enough supplies to cover the need for the resupply period.

IRT verifies that the selected minimum buffer quantity is always present at the site:

Ensures additional supplies are available at sites to replace damaged or missing trial supplies and to provide additional supplies for the pre-randomization period (subjects in screening).
Verifies that the selected minimum buffer quantity is always present at the site. If this threshold has been reached, IRT calculates the difference to supply up to the maximum buffer quantity.

When generating a trial supply order, the IRT system selects from the earliest expiring lot and picks drug units in ascending sequence number (for serialized drugs).

To protect the blind of the study, if only one drug unit if required to be shipped in a blinded study, IRT can be configured to randomly select an additional drug unit and order them together.