6 Receive and manage an investigational product

  • Confirm dispensation of kits
    If confirmation of dispensed kits is enabled in your study, then this task can be part of your workflow. You can confirm dispensation of any type of kit: kits for investigational products, kits used to change doses for a subject, reusable kits or devices.
  • Conserve and re-dispense kits
    Before conserving and re-dispensing kits, you need to determine whether the subject has any reusable kits. You can conserve and re-dispense these reusable kits during unscheduled visits, as well.
  • Conserve and re-dispense kits during a titration visit
    You can also conserve and re-dispense reusable kits for a visit when you have to perform dose changes for subjects.
  • Perform a partial dispensation
    Perform a partial dispensation to complete a visit when there are not enough kits available at the site to dispense. Partial dispensation is only available when a visit requires to dispense multiple kits of the same type and you have at least two kits available of each kit type that must be dispensed.
  • Pause dispensation by placing a dose hold
    As a blinded site user or a pharmacist, you have the option of pausing dispensation during a scheduled or unscheduled dispensation visit to ensure a subject's safety.
  • Register a shipment
    You must register every shipment you receive or Oracle Clinical One Platform won't be able to dispense the kits in the shipment. If you don't register the first shipment you receive, you won't be able to dispense kits to any subjects.
  • Replace a subject's lost or damaged kit
    You replace a kit only if a subject needs a replacement kit for a lost or damaged kit.
  • Mark a kit as missing or damaged at your site
    Mark a kit as missing or damaged only when it hasn't been dispensed yet and has gone missing or got damaged at your site.
  • Mark a kit that you didn't dispense to a subject
    Whenever a kit that was dispensed by Oracle Clinical One Platform never makes it to any subject's hands, you should update your inventory to indicate that the kit was never distributed.
  • Mark a kit that was dispensed in error
    If a kit was dispensed in error at your site, contact your CRA for assistance, and work together to correct the issue.
  • Request extra supply for a clinic day
    You should request a manual shipment only if you're having a clinic day and anticipate a surge of new subjects who will need the product dispensed on or soon after the clinic day. Otherwise, shipments are created as needed according to your site's planned or actual enrollment. If you are concerned that your site doesn't have adequate supply to meet day-to-day needs, talk to your CRA.
  • Check on a late shipment
    If a shipment is late, you can check its ship date to see when it left the depot.