Inventory management and dispensation FAQs (for clinical supply managers)

• What if a site anticipates an enrollment surge?
  Sites have a couple options when they are preparing for a clinic day.
• How often should I run inventory?
  You should consider a few factors when determining how often to run inventory.
• What levels of the supply chain can I manage in Oracle Clinical One Platform?
  You can manage shipments from depots to sites and manage inventory at each site.
• Which resupply strategy should I use?
  When choosing a resupply strategy for a site, consider the factors that should determine when a new shipment is created.
• Do I need to monitor product levels at sites?
  No. Oracle Clinical One Platform runs inventory to monitor product levels at sites, so as long as you created resupply strategies that meet sites' enrollment needs, you don't need to monitor product levels.
• How do I manage expiration dates and replenish stock to prepare for imminent expiration dates?
  A few settings help you manage the expiration dates of kits.
• How do I manage temperature excursions for kits and shipments?
  When a kit or shipment has a temperature excursion, a site user changes the status of all affected kits to Pre-quarantined. Next, you determine whether the kits can still be dispensed.
• How do I set the expiration dates for kits?
  You set expiration dates for kits by assigning them to manufacturing lots. Manufacturing lots in Oracle Clinical One Platform typically correspond to the lots created at the factory, though they don't have to. You must create at least one manufacturing lot in each study so you can set the expiration dates for kits.
• How does Oracle Clinical One Platform determine the kits that are selected for shipment or distribution to subjects?
  The following settings are considered: sequence numbers, expiration dates, and Do Not Ship and Do Not Dispense settings.
• Are all kits at a site counted in inventory?
  Only kits with certain statuses are counted in inventory.
• What if a subject loses or damages a kit?
  A site user can replace a lost or damaged kit during any visit.
• Can I track a kit from manufacturer to depot to site to subject?
  Yes. The Kit Chain of Custody (Unblinded) report contains this information.
• Can I change the contents of an automatic shipment?
  It depends on whether Oracle Clinical One Platform uses an integration for shipments.
• Understand kit conservation
  If some of the kits returned to the site by a subject are not expired or damaged, those kits can be conserved, and re-dispensed to the same subject.
• What is the workflow for shipments?
  This workflow applies to shipments when you don't use an integration for shipments, and it applies to all types of shipments, including the initial shipment to a site, a resupply shipment that is generated automatically when resupply runs, and a manual shipment.
• How do depots find out when a shipment is needed?
  Depots have two ways to find out when to create new shipments.
• What can I do to prevent my shipments from revealing unblinding information to site users?
  When you specify supply settings for a study, you indicate whether a shipment can contain only one kit. If the study is blinded, you typically do not allow a shipment to contain only one kit.
• When should I send initial shipments to sites?
  You have two options: After each site is activated, and after subjects start a specific visit.
• What if a depot has insufficient stock to resupply a site?
  After running inventory, Oracle Clinical One Platform checks whether the primary depot for the site has sufficient stock to fulfill the shipment. If the depot doesn't have sufficient stock, Oracle Clinical One Platform checks whether the secondary depot for the site has sufficient stock. If there is no secondary depot, the shipment cannot be fulfilled.
• Can depots ship different kit types?
  Yes. Just check that kit types and countries are associated appropriately in the settings for the depots.
• What if a site doesn't mark a shipment as received?
  The site might not be able to dispense. Only kits with a status of Available can be dispensed, so a site must mark shipments as received to be able to dispense the kits in the shipment.
• What do I do if a shipment is lost?
  You must mark the shipment as lost, and then check the supply settings to see when the resupply process runs next.
• What is my workflow for enabling confirmation of dispensed kits?
  To allow site users to confirm the dispensation of kits to subjects, you typically need to perform the following tasks in this order:
• Why are barcodes useful in a study?
  Whether you're a clinical supply manager or a site user, here's why barcodes are useful for you.
• Define kit dispensation logic
  Clinical supply managers choose how to define the dispensation logic in a study. Kits can be dispensed based on the lowest kit number or by the lowest sequence number.