• Select Yes if you want to ensure that randomization is prevented unless all required kit types are available in the site's inventory, in the necessary quantities.
• Select No to allow the randomization of subjects regardless of a site's inventory. By default, this setting is set to No.

Select Kits

Note: Available only whenYes is selected for Randomize Only when All Kits are Available at Site.

Select kit types that must be available at a site to allow for subject randomization. This is a multi-select field with a default of All.

• Select Yes if you want to let site users conserve and re-dispense a subject's reusable kits.
• Select No if you want to restrict site users from conserving and re-dispensing reusable kits to subjects.

• Select Yes if you want to let site users confirm kits are dispensed to each subject during a visit.
• Select No if you don't want to enable site users to confirm the dispensation of kits during each dispensation visit.

Choose the prefix to use for every shipment ID.

Select whether initial shipments are sent to sites when each site is activated, or after the first subject starts a particular visit, which you choose. Only one initial shipment is ever sent to a site, even if you change this setting in a live study.

Note: If you select First Subject in Visit Number, the Visit Number drop-down shows only scheduled visits.

(Available only when First Subject in Visit Number is selected for the previous field)

Select the visit that the first subject must start for initial shipments to be sent to a site.

Select Yes if a shipment can contain one kit. If the study is blinded, you typically select No.

Note: Single kit ordering is not supported for pooled kits.

(Available only when single kit ordering isn't allowed)

Select Yes if kits have different packaging requirements. Create blinded groups of the kits that ship together to protect the study blind.

If you select No, specify the kit that is added to single-kit shipments to protect the study blind.

(Available only when single kit ordering isn't allowed)

Select how kits are added to a shipment to protect the study blind when single-kit ordering isn't allowed. If you choose to send a specific kit type, the location where you choose the kit type depends on whether you have blinded groups. If you don't have blinded groups, you choose the kit type to add to the shipment on this page. If you have blinded groups, you choose the kit type to add to the shipment when you create a blinded group.

(Available only when single kit ordering isn't allowed, blinded groups aren't required, and you chose to send a specific kit type to prevent unblinding)

Select the kit type to add to a single-kit shipment to protect the study blind.

Select Yes if a kit type has more than one label. A label group is a collection of kits that use the same label.

Note: If you assigned the label to a depot in error, click Clear assigned label group to remove it from the Kit Settings.

(Available only when Yes is selected for Allow for Temperature Excursion)

Select Yes if you would like to allow single kits to be quarantined if they experience a temperature excursion.

(Available only when Yes is selected for Allow Temperature Excursions)

(Available only when Yes is selected for Allow for Temperature Excursion)

Provide a starting number for the shipment's tracking number. The number can begin with a value of one digit up to 8 digits that sequentially increment by 1.

Note: The starting number cannot begin with 0.

• Select Yes to create shipments according to the storage needs of the kit types. For example, kits requiring refrigeration are shipped separately from kits that require ambient storage. If kit reconciliation is required and kits are shipped to a depot for destruction, shipments are created based on the temperature requirements for the kits.
• Select No if all kits have the same storage needs.

• Select Daily to receive the Receive Shipment notification daily, depending on the days resupply is scheduled to run.
• Select Once to receive the Receive Shipment notification only once.

Insert the number of days after the ship date when the site user receives a notification to mark a shipment as received.

Note: If the ship date isn't defined, raise the date.

• Select Yes if sites can order a blinded shipment that you don't have to approve. You define the contents of the shipment in the resupply strategy that you assign to the site.
• Select No if the clinical supply manager will specify the contents of manual shipments that sites request.

Select the countries the selected kit type can be sourced from.

Select the countries whose kits can be locally sourced.