Manage kits at the site and study level

  • Access the Study Inventory tab
    The Study Inventory tab shows all kits, grouped by kit type. On the right, you can see the total number of kits, the number of dispensed kits, and the number of damaged kits for each kit type.
  • Access the Site Inventory tab
    As a Clinical Research Associate (CRA) or clinical supply manager, you may have to perform certain tasks on the Site Inventory tab.
  • Access the Depot Inventory tab
    As a blinded depot user or a clinical supply manager, you may have to fulfill some inventory tasks while protecting the study blind. If managing blinded kits at assigned depots is part of your responsibility, then you may need to work on the Depot Inventory tab:
  • Filter kits in a Study's Inventory tab
    Inventory filters are located at the top of the page. You can use these filters individually or in a combined way.
  • Filter kits in a site's inventory
    Inventory filters are located at the top of the page. You can use filters individually or they can be combined.
  • Search and filter kits on the Depot Inventory tab
    Inventory filters are located at the top of the page. You can use filters individually or combine them.
  • Manage non-serialized inventory
    Understand how non-serialized inventory differs from serialized inventory, and how you can manage it in your study.
  • Add non-serialized kits to a lot
    To distribute non-serialized inventory, sponsor users can assign non-serialized kits to lots.
  • Monitor site and depot stock levels
    As long as resupply strategies meet sites' enrollment needs, you don't need to monitor product levels. However, you might want to monitor supply levels at the beginning of a study to make sure the resupply strategies meet the sites' needs. This procedure also applies to rollover studies.
  • Transfer the product to another location
    You can transfer an investigational product to another site to minimize waste, such as when a site doesn't enroll as anticipated. This procedure also applies to rollover studies.
  • Mark kits to test for temperature excursions
    Before quarantining your kits, determine if they have experienced a temperature excursion.
  • Quarantine kits
    Mark individual kits as Quarantined if they've experienced a temperature excursion.
  • Mark a kit as missing or damaged
    Kits at sites and depots can be marked as missing or damaged. This procedure also applies to rollover studies.
  • Reserve kits for a quality check
    Two kit statuses are available when you need to reserve kits for a quality check: Temporarily Unavailable and Not In Use. These two statuses give your organization flexibility for managing kits that are unavailable for distribution. This procedure also applies to rollover studies.
  • Update the status of a kit for a site user
    Site users should update the kit status themselves whenever possible. If you're a CRA, and a site user asks you what to do about the status of a kit that is no longer available, instruct them to perform this task. If you're a clinical supply manager who needs to update the status of a kit that should be available in the inventory, follow this procedure.
  • Update a kit's barcode
    There may be cases during a study when a clinical supply manager should manually update a kit's barcode. Follow this procedure to know more about a clinical supply manager can do.
  • Available inventory statuses for kits
    Kit statuses allow you to manage shipments and inventory in your study. Here's a list of every status a kit might have in Oracle Clinical One Platform and their descriptions.
  • Allowed updates for inventory status
    Kits in certain statuses cannot be directly updated to a specific status. This is applicable for regular and non-serialized kits, and for updates done in both the study inventory and site inventory pages.
  • What if a site user dispensed a kit in error?
    You next steps depend on what happened.

Parent topic: Work during the study conduct period