10 Kit types and dispensation schedules

You can define various types of kits, from kits containing the investigational product, kit type titrations, to devices and kits that only an unblinded pharmacist can dispense.

• Define the kits for investigational products
  When you create kit types, you specify details about the kits, including storage details and whether doses are calculated based on subjects' answers questions. This procedure applies for defining kit types in a rollover study, as well.
• Define kits with calculated doses
  When you create kit types for the investigational product, you can choose whether calculated doses should be included or not, along with other storage details.
• Define the kits for devices
  Create one kit type for each type of device that is dispensed. Devices might include scales or blood pressure monitors, for example. If the study doesn't dispense devices, you can skip this step.
• Define kits for titrations
  When subjects can titrate, you must define the titration rule by creating titrations. Create one titration for each treatment arm. Every kit type in the titration must contain the same product and should have the same distribution status (either blinded or unblinded). This procedure can also apply to rollover studies.
• Import a pooled kit type
  After you or another library user create the pooled kit type, approve it in a library study, and then publish it, you can import that kit type into a Production study.
• Specify when subjects can titrate
  Perform this task only if the protocol allows subjects to titrate based on input from a clinician at the site. This procedure also applies to rollover studies.
• Define the dispensation schedule
  When you define the dispensation schedule, you choose the visits in which kits are dispensed, the quantity to dispense, and other details. Kits can contain either investigational products or devices. This procedure also applies to rollover studies.