Kit and dispensation FAQs (for study designers)

• Can I create kit type titrations for blinded studies with open-label periods?
  Yes, you can. Create separate kit types for the blinded and open-label periods if the kit type description must be visible to blinded Oracle Clinical One Platform users during the open-label period.
• Can I dispense the same kit types in more than one treatment arm?
  Yes. You can dispense a kit type in one or more treatment arms, or you can dispense a kit type to all subjects without associating it with a treatment arm.
• Can I include Unblinded Pharmacist kits in a kit type titration?
  Yes, you can. However, you need to be very careful. Combining regular kit types with kits that can only be dispensed by a pharmacist or unblinded site user, in a kit type titration may, result in the potential unblinding of kits to blinded site users.
• If a study has multiple periods, how many kit types should I create?
  When a study has both an open-label and blinded period, your process for creating kit types depends on whether kit type descriptions should be visible to blinded users.
• How many treatment arms should I create when the same treatment arm is part of both blinded and open-label periods?
  Create only one treatment arm. The unblinding setting on the randomization design determines whether the treatment arm title is visible to blinded users.
• I'm not using Oracle Clinical One Platform for dispensation and supply management. Do I have to create kit types?
  No.
• How do I define the requirements for the investigational product?
  Create kit types to define the requirements, such as storage temperature, type of drug and calculated doses. You create one kit type for each category of kit that will be dispensed.
• Can dispensation occur outside the visit window?
  Yes. When you create the dispensation schedule, you specify whether a kit can be dispensed out of window for each visit or if site users can dispense kits to subjects during an unscheduled visit.
• Can dispensation occur outside a randomization visit?
  Yes. You can dispense when you randomize, and before and after you randomize.
• Can an open-label product be dispensed to all subjects?
  Yes. When you create the dispensation schedule, associate the kit type either with all subjects (if the visit occurs before randomization) or with all treatment arms (if the visit occurs after randomization), and select the visits with dispensation events.
• Can I create an open-label study or an open-label period?
  Yes. You can create open-label periods, including open-label extensions, and an entirely open-label study.
• What do I need to do to use calculated doses?
  You create a study as you normally do, but you need to make sure to set up forms, visits, kit types, and the dispensation schedule in a specific way.
• Can more than one kit type be dispensed in a treatment arm?
  Yes.
• What is my workflow if subjects need to titrate?
  Your workflow depends on whether you titrate according to a predefined schedule, or you let subjects change doses based on input from a clinician at the site.
• What happens when subjects aren't allowed to titrate?
  Your next steps depend on the reason the subject wasn't allowed to titrate.
• What if subjects can titrate some kits and not titrate others?
  It's not a problem at all. The workflow is exactly what you expect.
• Can I include multiple products in the same kit type titration?
  We recommend you include only one product in a kit type titration. A kit type titration can include multiple dose levels (for example, 5 mg and 10 mg kit types), typically for the same compound. You can assign only one kit type titration to a treatment arm, so subjects can titrate only one compound for each treatment arm.
• Can a site user change doses after re-randomization occurs?
  Yes. Site users can dispense kits during titration visits after a subject is re-randomized to either the same treatment arm or a different treatment arm after the titration period.
• Can a site user change doses prior to randomization during the study?
  Yes, they can. There is no study design rule that doesn't allow site users to dispense kits to subjects during titration visits, before randomization happens.
• What is my workflow for creating device kit types managed with Oracle mHealth Connector?
  Your workflow for creating device kit types managed with Oracle mHealth Connector so that the study can dispense devices is similar to your workflow for creating kit types for dispensing drug kits, with one important addition: you must configure the connection to Oracle mHealth Connector when the study dispenses devices.