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.

Learn more about kits and dispensation in the FAQs.

Want to see how to perform this task? Watch the video below.

Only visits that occur during or after randomization will be available if you associated the kit type with one or more treatment arms.

  1. Access the Draft version of a study as described in Open a study's design.
  2. Click Study Supplies.
  3. Click the Kits tab.
  4. On the Visits & Events pane, locate the first dispensation event defined in the study protocol.
  5. Drag the kit type to the visit. If the study allows titration, you should drag the kit type that subjects start on for a given treatment arm.
  6. Click in the Select Treatment Arm field, and select an option from the drop-down:
    • If the visit occurs before randomization, select All Subjects.
    • If the visit occurs during or after randomization, select one or more treatment arms to associate the kit type with, or select All Treatment Arms.
    • If the visit is unscheduled, either select All Subjects, select one or more treatment arms to associate the kit type with, or select All Treatment Arms.
  7. Select the appropriate visits:
    • If the study doesn't allow titration, select all other visits in which the kit must be dispensed. You can use the column-level checkbox to select all visits.
    • If the study allows titration, select no other visits. You'll associate the appropriate kit types with future dispensation visits when you Define kits for titrations.
  8. Fill in the fields, and click Add.
    To view tips for completing a field, click into the field.
    Field Description
    Quantity Enter the number of kits to dispense in the visit.
    DND (Days) Enter the minimum number of days before the kit's expiration date that the kit cannot be dispensed to a subject. For example, if the kit has enough product for 30 days, and the patient can come in up to 7 days after the scheduled visit, the DND must be at least 37.
    Dispense Outside Window Choose Yes if kits can be dispensed outside the visit window. Choose No to prevent site users from dispensing to subjects who come in outside the visit window.
    Calculated Dose (Appears only for investigational product kit types): If the study determines doses based calculations, select the calculated dose that determines the dispensation requirements for the visit. You can select a different calculated dose for each visit. The question that is used to calculate the dose must be asked during or before the visit. For example, if Dosing Calculation 1 is based on weight, and you collect weight in Week 2, you can't select Dosing Calculation 1 for Week 1. If the study doesn't use calculated doses, leave the field blank.
    An icon appears on the visit, indicating that dispensation occurs during the visit. A pill icon appears for an investigational product kit type, and a device icon appears for a device kit type.
Tips:
  • To check the work you did on a visit, add and reorder more forms in a visit, or edit a visit ID or type, click the visit in Visits & Events.
    • To see dispensation details, click the pencil button on a treatment arm, and select a kit type from the drop-down that appears.
    • To remove the association between a kit type and visit, click the trash can for the kit type.
    • To change the visit type or ID, click the pencil for the corresponding fields in the upper-left corner of the visit flyout.
  • You can't dispense kits in a withdrawal or completion visit.