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.

To define the dispensation schedule, you can add normal kits, devices, kits with calculated doses, titrations or advanced dispensations.

You must first create all required kit types for a study. For step-by-step instructions, see:

• Define the kits for investigational products
• Define the kits for devices
• Define kits with calculated doses
• Define kits for titrations
• Define advanced dispensation of kits

Learn more about kits and dispensation in the FAQs.

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

1. Access the Draft version of a study as described in Open a study's design.
2. Select Study Supplies.
3. Select the Kits tab.
4. On the Visits & Events pane, locate the first dispensation event defined in the study protocol.

   Note:

   You can add dispensation to visits prior randomization if you intend to dispense to all subjects. Conversely, if the kit type dispensation is associated to one or more treatment arms, you must add dispensation events only in visits that occur during or after randomization.

   Also, you can't dispense kits when subject is screen failed, nor in a withdrawal, completion, or adverse event visit.

5. Drag the kit type (investigational product, investigational product with calculated doses or device), or advanced dispensation to the visit.
   • If the study allows titration, you should drag the kit type that subjects start on for a given treatment arm. After completing all these steps to define the dispensation for the starting dose kit type, Specify when subjects can titrate.
   • If you are working with advanced dispensations, you must consider the defined criteria. If the advanced dispensation uses any criteria that cannot be verified for a given visit, for example using the randomization date in the screening visit (prior randomization), dispensation will fail.

   WARNING:

   Be careful not to add multiple dispensations of the same kit to the same visit, this includes advanced dispensation, titration and standalone kits. If dispensation of a same kit type is defined more than once in a visit, dispensation will fail.

   For example, a subject may fall into one group of the advanced dispensation that must be dispensed with kit A, while the same visit is configured for kit A titration. It may also happen that a same subject falls into two different groups of the advanced dispensation (meeting the specified criteria for both), and both groups dispense the same kit in different quantities. In both cases, the design must be evaluated and the dispensation schedule updated.

6. Fill in the fields in the Add Kit to Visit Schedule dialog:
   If you are adding and advanced dispensation, a different screen for each group is available to define its settings individually. After completing all fields for one group, click Next to move on to the next group.
   1. Click in the box and select an option from the drop-down:
      • For visits occurring before randomization, select All Subjects.
      • For visits occurring during or after randomization, select one or more treatment arms to associate the kit type with, or select All Treatment Arms.
      • For unscheduled visits, select any applicable option.
   2. In the table below, select the appropriate visits:
      • If the study doesn't allow titration, select all other visits in which the kit or advanced dispensation kits 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 and Specify when subjects can titrate.
   3. Complete the rest of the settings for the selected visits:
      To view tips for completing a field, click into the field.

      Field	Description
      Quantity	Enter the number of kits to dispense in the visit. Note: For advanced dispensation, all kits to be dispensed have a defined multiplier that defines the amount of kits of a given kit type in one round of treatment. This quantity field determines an additional multiplier, that constitutes the number of complete rounds of treatment to be dispensed.
      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	Displays only for investigational product kit types with calculated doses. From the drop-down, select the calculated dose that determines the dispensation requirements for the visit. You can select a different calculated dose for each visit. Note: 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.

7. Select Add to save your changes in the dispensation schedule.

An icon appears on the visit, indicating that dispensation occurs during the visit:

• A pill icon displays for visits with dispensation of an investigational product kit type.
• A device icon displays for visits with dispensation of a device kit type.
• A titration icon displays for visits that allow titration.
• A pill with a DNA helix icon displays for visits with advanced dispensation.

You can add other kit types to the dispensation schedule using these same steps. To add titration definitions, see Specify when subjects can titrate.

To check the visit configuration, including your changes about dispensation, select the visit in Visits & Events.

• To see dispensation details for a kit on a treatment arm, select the edit icon (
  
  
  
  ) on a treatment arm. If multiple kit types are associated with the treatment arm, select one from the drop-down to view its details.
• To remove the association between a kit type and visit, select the delete icon () for the kit type within the given treatment arm.
• To change the visit ID, select the edit icon (
  
  
  
  ) for the corresponding field in the upper-left corner of the visit dialog.
• You can drag and drop to reorder forms or add more forms in a visit using the Add form icon (+), on the Forms pane to the left of the dialog.