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Smart System module described
The Smart System module alerts you to potential stock-outs during enrollment and gives you the option of automatically generating supply orders based on the potential need for subjects in screening.
IRT calculates the projected run-out date based on:
- The number of subjects enrolled (using standard trigger and resupply week projections).
- Study screening and screen failure rate.
- The potential assignment for screened subjects (as determined by the treatment block ratio).
Virtual Treatment blocks maintain the treatment ratio in the randomization list to predict assignments for screened subjects. The number of blocks depends on:
- The number of screened patients with projected randomization within threshold window
- Screen failure rate (if applied)
- The randomization list block size
The Smart System module compares the calculated run-out date against the Smart System trigger date. If the projection for available drug units is less than the threshold window, the Smart System module triggers the Potential Stock-Out Alert and, if configured, creates a shipment to fulfill the need.
Independent of the minimum buffer, maximum buffer, and standard resupply algorithms:
- The Smart System module considers the standard resupply settings.
- If resupply generates order insufficient to cover for Smart System projections, Smart System compensates for this extra need (if configured to send additional supply automatically)
The content of the shipment is based on:
- Projections for next treatments to be assigned for all screened subjects within threshold window.
- Follows the standard rule: Projected Need (PN) - Site Availability Inventory (SAI)
- The number of projected treatments is evenly divisible by sum of treatment ratio value.
- The treatment ratio is 3 active subjects and 2 Placebo subjects. So the sum is 5.
- The block size is therefore 5.
- If two patients are in screening, since the block size is 5, we need one block.
- To meet projected demand, the Smart System orders 3x Active Subjects and 2x Placebo subjects.
