Supply settings fields

This reference provides you with the fields and their descriptions when specifying supply settings for a study.

Schedule Settings

Field Description
Days to Run Inventory Choose the days of the week when the resupply process runs for every site.
Time to Run Inventory Choose the time when the resupply process runs.

Inventory Settings

Field Description
Site Kit Reconciliation Required Choose Yes if you want to manage the return or destruction of any unused product from within Oracle Clinical One Platform at a site.
Dispense Kits By

Select whether kits are dispensed by Lowest Kit Number & Closest Expiration Date or Lowest Sequence Number & Closest Expiration Date.

Dispensing by lowest kit number is helpful when you store your kits in a physical space.

Dispensing kits by lowest sequence number is the default method where kit numbers are scrambled.

Depot Kit Reconciliation Required Choose Yes if you want to manage the destruction of any shipments from within Oracle Clinical One Platform at a depot facility.
Randomize Only when All Kits are Available at Site

Choose No to allow the randomization of subjects regardless of a site's inventory. By default, this setting is set to No.

Choose Yes if you want to prevent randomization when site has no kits availabile of either all or specific kit types.

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.

Dispense Reusable Kits

Choose Yes if you want to let site users conserve and re-dispense a subject's reusable kits.

Or choose No if you want to restrict site users from conserving and re-dispensing reusable kits to subjects.

Dispense only reusable kits from a subject's last dispensation visit Click the checkbox if you want to set a limit for site users to only see conserved kits from a subject's last dispensation visit. If this setting is enabled, site users only see reusable kits from a subject's latest dispensation visit as opposed to seeing reusable kits from all previous dispensation visits.
Request Sites to Confirm Dispensation

Choose Yes if you want to let site users confirm kits are dispensed to each subject during a visit.

Choose No if you don't want to enable site users to confirm the dispensation of kits during each dispensation visit.

Shipment Settings

Field Description
Shipment ID Prefix Choose the prefix to use for every shipment ID.

Note:

  • For shipments sent through the Oracle Clinical One Platform - Fisher Clinical Services integration, only IDs that contain numbers are accepted. To make sure you use the right Shipment ID prefix, select Use Depot ID or None. If a depot ID contains leading zeros, they do not appear in the Shipment Request file as part of the Shipment ID format for Fisher Clinical Services.
  • For shipments sent through the Oracle Clinical One Platform - Catalent Clinical Supply Services integration, Shipment ID prefixes must consist only of numbers. To make sure you use the right Shipment ID prefix, select Use Depot ID (if depot IDs are defined using numbers only), Enter Prefix to use a prefix that consists only of numbers or None, if no prefix is used.
Send Initial Shipments Choose 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 choose First Subject in Visit Number, the Visit Number drop-down shows only scheduled visits.
Visit Number

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

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

Single Kit Ordering Allowed 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.
Blinded Groups Required (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.

Kits Added to Prevent Unblinding

(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.

Kit Type

(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)

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

Label Groups Required 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.
Allow for Temperature Excursion Select Yes if any kits are sensitive to temperature excursions. A kit that experiences a temperature excursion cannot be dispensed until data about the excursion has been reviewed.
Allow Single Kit Quarantine

(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.

Shipments Received without a Temperature Monitor Should be (Available only when Yes is selected for Allow Temperature Excursions)

Select Quarantined if you would like kit statuses to update to Quarantined if they are received without a temperature monitoring device.

Choose Allow to Continue to Receipt Process to let kits received without a temperature monitor to progress through the receipt process.

Temperature Excursion Starting Number (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.
Multiple Storage Requirements

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.

Notification Schedule 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.

Notification to Receive Shipment (in days) 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.
Site Can Request Shipments

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.

Locally Sourced Kit Settings

For step-by-step instructions on configuring locally sourced kits, see Add a locally sourced kit.

Field Description
Kit Type Select the type of kit that can be locally sourced.
Locally Sourced Countries Select the countries the selected kit type can be sourced from.

Note:

A country can only be added to either Locally Sourced Countries or Sourced by Site Countries, but not added to both.
Sourced by Site Countries Select the countries whose kits can be locally sourced.

Note:

A country can only be added to either Locally Sourced Countries or Sourced by Site Countries, but not added to both.