Define the kits for devices

Create one kit type for each type of device that is dispensed. Devices might include scales or blood pressure monitors, for example. If the study doesn't dispense devices, you can skip this step.

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

If investigational and other drug products are dispensed during the study, create kit types for each drug product.

To create a kit type device:

1. Access the Draft version of a study as described in Open a study's design.
2. Click Study Supplies.
3. Click the Kits tab.
4. Click Create Kit Type and click Device.
5. Fill in the remaining fields and click Add.
   To view tips for completing a field, click into the field or choose an option.

   Field	Description
   Device Type	Choose the type of device from the drop-down. This value is visible to blinded users.
   Device Connection	Choose the type of IoT (Internet of Things) connection option for the device. If you're not sure what to select, contact the vendor of the device. Cloud to Cloud: For a device that connects to the Oracle mHealth Connector Cloud Service via the device vendor’s cloud service. When a site user dispenses a device with a Cloud to Cloud (C2C) connection, the site user must enter Vendor Code to register and activate the device. Device to Cloud: For a device that connects directly to the Oracle mHealth Connector Cloud Service. When a site user dispenses a device with a Device to Cloud (D2C) connection, an access code and password from Oracle mHealth Connector are displayed to the site user. The site user must enter these values into the device for the device so they can register and activate it. Note: You can dispense only one Device to Cloud device to each subject in a study. No Connection: For a device that doesn't connect to the Oracle mHealth Connector Cloud Service.
   Distribution Settings	Note: This field has unblinding consequences. Make sure you set it correctly. If blinded users should never see the kit type description, choose Blinded. If blinded users should always see the kit type description, choose Unblinded.
   Kit Type ID	Enter an identifier for the device, such as A.
   Description	Enter the name of the device. If the kit type is unblinded, make sure the description is appropriate for blinded users.
   Storage Temperature	Choose the storage temperature requirements for the devices (ambient, refrigerated, or frozen). If you're not sure, work with the clinical supply manager.
   Minimum Units to Ship	Enter the minimum number of devices to include in each shipment to meet packaging requirements. For example, for a box of 6 individually labeled scales, the value is 6.

Adding kits to your study is a multi-step process. After defining the kit types, you must:

• Define the dispensation schedule.
• Upload or generate a kit list in Testing mode or Production or Training mode. See Generate or upload a kit list.

  A kit list assigns unique numbers to every kit that will be dispensed. After you create a kit list, sponsor and depot users can start managing kits individually.