Configure advanced dispensation for your study

You can now create advanced dispensation definitions with different dispensation instructions and associated kit types for different groups of subjects.

When defining an advanced dispensation design, you can add as many groups as needed in your study. For each group, you specify the kit types and quantities to dispense to subjects within that group. You define a group by setting the criteria that subject must meet to be considered part of it. That criteria can come from a form question answer or from any other system variable, such as:
  • Randomization date
  • Screening date
  • Current visit date
  • Cohort
  • Treatment arm

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.

Details for study designers

If you want to start using the advanced dispensation feature, here's what's new for you, as a study designer:

Note:

You still need to create the individual kit types to be used in the advanced dispensation. The process to create kit types, both simple and with calculated doses remains unchanged.
  • In Draft mode, within the Kits tab in Study Supplies, there is a new button called Create Advanced Dispensation. Clicking it opens a dialog that guides you through the process of defining the advanced dispensation design.
  • Within the advanced dispensation definition, you can add as many groups as needed. Each group constitutes a subset of subjects that meet specific criteria and that will have specific dispensation and dosing instructions. The group criteria can be set based on form question answers or other subject variables.
  • You must define the criteria that qualify a subject for inclusion in each group. You can define as many criteria elements as needed, but you must define at least one.

    Caution:

    When setting up the criteria for each group, you must consider the following:
    • If you add multiple criteria elements, all must be met for a subject to be included in the given group.
    • If a subject meets the criteria for multiple groups, then kits defined in all of those groups would be dispensed to the subject.
    • Consider all possible scenarios carefully to prevent assigning subjects to multiple groups that dispense the same kit. If dispensation of the same kit type is defined more than once in a visit for the same subject, dispensation will fail.
  • For each group you must also define the specific kit types and quantity to be dispensed, as well as the dosing instructions that display to site users when dispensing to subjects in that group.

    You may select different kind of kit types, including Blinded, Unblinded, Unblinded Pharmacist kits and calculated doses, both serialized and non-serialized.

  • After creating the advanced dispensation definition, you must add it to the required visits in the visit schedule. This step ensures its inclusion in the dispensation schedule of your study.

    Caution:

    • You must consider the defined criteria. If the advanced dispensation uses criteria that cannot be verified for a given visit, for example using the randomization date in the screening visit (prior randomization), dispensation will fail.
    • Avoid adding multiple dispensations of the same kit to a 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.

You can find additional information in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Details for sponsor users

If your study begins using advanced dispensation, most of your workflows remain unchanged. However, there are a few things you must consider when it comes to partial dispensation and dose hold configuration:
  • You define both partial dispensation and dose holds for the individual kit types, not for an entire advanced dispensation definition or for a group. This is because multiple kit types, in multiple combinations, can be defined for multiple groups.
  • Partial dispensation is only possible when a visit requires dispensing multiple kits of the same type. This requires that you have at least one kit available of each kit type that is to be dispensed.

Details for site users

There are no changes in your workflow, as you should always dispense all of the kits indicated by the system.

Partial dispensation and dose holds are allowed in studies using advanced dispensation, with the same considerations as with standalone dispensation:
  • Both partial dispensation and dose holds are defined for individual kit types and therefore must be performed on individual kit types.
  • Partial dispensation is only possible when a visit requires dispensing multiple kits of the same type. This requires that you have at least one kit available of each kit type that is to be dispensed.

Impact on reports

The following reports have been updated to support advanced dispensation:
Report Type of change Description
Study Design report Modified tables
  • The Data Collection Design Summary section, includes advanced dispensations in the Kits Dispensed column when associated with a given visit.
  • The main table in the Kits section includes details of the existing advanced dispensations.
  • The Kit Dispensation section includes details of the existing advanced dispensations when associated with a given visit.
Study Design report New section
An Advanced dispensation section is added to this report, which includes the following information for each advanced dispensation definition:
  • Group name.
  • Group criteria for each group.
  • Kits to be dispensed for each group.
  • Dosing instructions for each group.
Kit dispensation report New column The Dosing Instructions column is added to display the dosing instructions for the group to which the subject belongs to, when using advanced dispensation.

You can find additional information and specific descriptions on modified report values in the Reporting Guide after the RAE upgrade.

Already working in a live study?

As soon as this release is available, you can start using advanced dispensation in your study. Create the advanced dispensation definition and update your dispensation schedule accordingly. To avoid dispensation failures, be careful not to add multiple dispensations of the same kit to the same visit. This considers kits in advanced dispensation, titration and standalone kits. You may need to remove the association between visits and existing kit types.

If you modify the dispensation schedule to use advanced dispensation 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. We highly recommend you properly test all possible dispensation scenarios in Testing mode.

Parent topic: Randomization and Trial Supply Management