Specify supply settings

Typically, a clinical supply manager specifies these settings. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies.

Note:

We recommend you set and verify these settings in Testing mode first. Specify supply settings for Production mode once you have verified that the study design and settings are working as expected in Testing, then make Training mode settings match.

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

1. Open the study settings.
2. Below the study name, click the Supply Settings tab.
3. On the top left, select a specific mode:
   • Production Settings
   • Testing Settings
   • Training Settings
4. Fill in the fields.
   To view tips for completing a field, click into the field or choose an option to reveal a tool tip. Refer to Supply settings fields for fields descriptions.
5. In the upper right, click Apply Changes.

• If your study allows sites to perform partial dispensation, Create and manage a partial dispensation.
• If your study allows sites to perform does holds, Create or edit a dose hold.

Specify these settings for other modes in your study, if you haven't already and when required.

• Supply settings fields
  This reference provides you with the fields and their descriptions when specifying supply settings for a study.
• Add a locally sourced kit
  Define locally sourced kits for your study to allow sites in specific countries to dispense kits from local distributors, instead of kits contained in Clinical One. This allows flexibility when new products are made commercially available.
• Create and manage a partial dispensation
  Define partial dispensation settings to allow site users to complete a visit when there are not enough kits available at the site to dispense. Partial dispensation is only available when the dispensation of multiple kits of the same type is required for the visit and you have at least one kit available of each kit type that must be dispensed.
• Understand combination kit dosing
  Combination kit dosing is helpful in ensuring subjects are dispensed the correct dosage.
• Define combination kit dosing
  Create a combination kit dosage.
• Understand how dose holds work
  Dose holds are crucial when an investigator needs to pause dispensation and respond appropriately to subjects' experiences concerning their health and well being. To make sure this feature is properly configured in a study, several types of users must do their part in creating and applying a dose hold.
• Create or edit a dose hold
  Create a dose hold to enable site staff to pause dispensation of a specific kit type for a subject due to safety reasons. A dose hold can be created in all three modes: Testing, Training, or Production.
• Create a min/max resupply strategy
  You create a min/max resupply group to resupply a site or a depot only when their inventory is low. When the application checks inventory and subject ranges, shipments are created as needed to bring the inventory at sites or depots up to the maximum number of kits you specify.
• Create a predictive resupply strategy
  You create a predictive resupply group to resupply a site based on actual enrollment and planned dispensation visits. After running inventory, the application creates shipments to meet each site's inventory requirements for the coming weeks. You specify the number of weeks to consider and the number of weeks to order for. You also set minimum and maximum levels so that sites have sufficient supply for new subjects.
• Create a blinded group of kits
  Create blinded groups if you don't allow single kit ordering, and if the kits in your study use different packaging. Blinded groups determine the kit or kits that are added to a single-kit shipment to protect the study blind. This procedure also applies to rollover studies.