Define advanced dispensation of kits

You can define advanced dispensation of kits by creating advanced dispensation definitions and adding them to your dispensation schedule instead of standalone kits. Using advanced dispensations allows you to apply different dispensation instructions and associated kit types for different groups of subjects.

For example, in a pediatric study you can configure different formulations of the investigational product (suspension, pills, and chewable tablets) based on the subject's age.

To create an advanced dispensation you must first create the kit types to be used in the advanced dispensation definition. See Define the kits for investigational products

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. Select Create Advanced Dispensation.
5. In the Create Advanced Dispensation dialog, enter a title.
6. Start by adding a group by selecting Add New Group. Add as many groups as needed.
   Each group constitutes a subset of subjects that meet a specific criteria and that will have specific dispensation and dosing instructions. Within an advanced dispensation definition, you can have multiple groups which constitute multiple dispensation variations based on form item answers or other variables. Each group is later defined.
7. Define each group:
   To view tips for completing a field, click into the field or choose an option.
   1. In the Group Name section, enter a name for the group.
   2. In the Group Criteria section, click Add Criteria and select an option to define the criteria elements that determine which subjects belong to this group:
      Add as many criteria elements as needed for each group. At least one needs to be defined to determine dispensation logic.

      Note:

      If you add multiple criteria elements, all must be met for a subject to be included in the given group.

      WARNING:

      Consider all possible scenarios, and avoid having subjects falling into more than one group that dispenses the same kit. If a subject meets the criteria for more than group, kits defined in all those groups will be dispensed. However, if dispensation of a same kit type is defined more than once in a visit for the same subject, dispensation will fail.

      For example, one subject falls into two different groups of the advanced dispensation (meeting the specified criteria for both), and both groups dispense the same kit, maybe in different quantities. In this case, the advanced dispensation design must be updated to avoid dispensation failures.

      Option	Description
      Form Item	Select a form item and the answer that defines which subjects belong to this group. Only number, date and multi-select questions (checkbox, drop-down and radio buttons) are allowed. Select a visit from the Select Visit drop-down. Select a form from the Select Form drop-down. This drop-down gets enabled only after you select a visit. The list of available options is populated based on your visit selection. Only flat forms are available for selection. Select a question from the Select Question drop-down. This drop-down gets enabled only after you select a form. The list of available options is populated based on your form selection. Depending on the type of question, select a specific answer or set a rule. Subjects with the specified answer will be considered as part of this group. For number and date questions you can set a comparison rule such as: Greater Than or After Greater Than or Equal To or On or After Less Than or Before Less Than or Equal To or On or Before Is or On Not Equal To or Not On Not Between Range Tip: It is recommended to use Auto-lock rules for form items that are part of the advanced dispensation definition. This is to avoid impacting the subject's dose with subsequent changes. See Set up a question to lock automatically
      Variable	Select a variable and the specific condition that defines which subjects belong to this group. Select a variable from the Select Variable drop-down: System Randomization Date Note: This considers only the first randomization date. Re-randomization is not taken into account. System Screening Date System Visit Date Cohort Treatment arm Set the variable condition. Subjects that meet this condition will be considered as part of this group. For date-type variable: Select a comparison operator (Before or After) and set a date. Note: System dates are converted to the site time zone for these calculations. For Cohort or Treatment Arm variables: Select a specific cohort or treatment arm respectively. You may select multiple options. Note: You should not use Cohort when designing advanced dispensation for a forced randomization visit, as the system will not assign the cohort until after the subject is randomized. If this is implemented the system will only check the kits for the first open cohort and the randomization may fail due to not enough kits at the site.

   3. In the Kit Settings section, define the kits to be dispensed for subjects in this group:
      1. Click Add Kit to add a kit type to define.

         Add as many kit types as needed. At least one kit needs to be added for dispensation for each group.

      2. For each Kit Description, select a kit from the Select Kit drop-down.
         You may select different kind of kit types, including Blinded, Unblinded, Unblinded Pharmacist kits, calculated doses and devices. Both serialized and non-serialized kits are allowed.

         • If you include kits with calculated doses, from the drop-down that appears below the kit name, select the specific calculated dose to be dispensed.
      3. In the Number of kits textbox, enter the number of kits of that kit type to dispense. This number acts as a multiplying factor for the selected kit type.

         The total number of kits, of all the kit types to be dispensed for a same group, constitutes one round of treatment.

   4. In the Instructions section, enter the text to display as dosing instructions for the site user, upon dispensation for subjects in this group.

      Note:

      These instructions must consider all kit types to be dispensed for the group. These instructions overwrite any dosing instructions defined at any kit level, including calculated doses.
8. To copy a group within the same Advanced Dispensation definition: click the copy icon () next to the group's title.
9. To delete a group within an Advanced Dispensation definition: click the delete icon () next to the group's title.
10. Select Create.

You can manage an Advanced Dispensation definition at any time. From the Kits tab within Study Supplies in Draft mode:

• To copy an Advanced Dispensation definition: click the copy icon () next to the Advanced Dispensation title.

  The Create Advanced Dispensation dialog displays, allowing you to add a new name and modify the details of the new definition to be created.

• To edit an Advanced Dispensation definition: click the edit icon () next to the Advanced Dispensation title.
  The Create Advanced Dispensation dialog displays, allowing you to modify it.

  Note:

  If you modify the advanced dispensation definition used in a live study, the updates will apply to all subjects for upcoming dispensations once the new study version with the updates is approved and assigned to the site.
• To delete an Advanced Dispensation definition: click the delete icon () next to the Advanced Dispensation title.

  A Delete Advanced Dispensation dialog displays, allowing you to confirm the action.

  Note:

  You can only delete an Advanced Dispensation definition as long as it is not used in the visit schedule. If used, the delete action will fail and an error message displays.

To use the Advanced Dispensation in your study, add it to the visit schedule:

• You can add advanced dispensation to any visit, but if the treatment arm is used in the definition it must be a visit on or after randomization.
• You must consider all the used criteria elements when you add the advanced dispensation to the schedule. If there is 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.

For more information, see Define the dispensation schedule.