What is my workflow for creating device kit types managed with Oracle mHealth Connector?

Your workflow for creating device kit types managed with Oracle mHealth Connector so that the study can dispense devices is similar to your workflow for creating kit types for dispensing drug kits, with one important addition: you must configure the connection to Oracle mHealth Connector when the study dispenses devices.

1. Make sure the Study Name field in Oracle mHealth Connector is identical to the Study ID field (on the General tab in Study Settings) in Oracle Clinical One Platform. If these fields aren't identical, data from the devices won't appear as expected in the appropriate application.
2. Study Name in Oracle mHealth Connector must match the Oracle Clinical One Platform Study ID.
3. Configure the connection to Oracle mHealth Connector:
   1. Obtain the following information from Oracle:
      • Production, Training, and Testing URLs for Oracle mHealth Connector.
      • User name and password for an Oracle mHealth Connector user. The user account is typically a service or integration account and isn't used by a user to sign in to Oracle mHealth Connector. If you don't have the user name or password, work with the delegated administrator who is responsible for provisioning users in Oracle Life Sciences IAMS to obtain the user name and password.
   2. Using the URLs and account information you obtained from Oracle, configure the connection to Oracle mHealth Connector so you can dispense devices.
4. Design the study as usual, including performing the following steps required for devices:
   1. Define the kits for devices.
   2. Define the dispensation schedule.
5. Specify settings for Testing mode as usual, including performing the following steps required for devices:
   1. Associate each device kit type with the depot(s) that ship the devices.
   2. Include device kit types in resupply strategies.
   3. Generate or upload a kit list.
   4. Create at least one manufacturing lot for the devices for Testing mode so you can specify their expiration dates, and combine the manufacturing lots into blinded lots if required.
   5. If you're using blinded groups for devices, create a blinded group of kits for devices for Testing mode.
6. Specify settings for Production mode as usual, including performing the following steps required for devices:
   1. Create a predictive resupply strategy [Testing].
   2. Generate or upload kit lists for Production and Training modes.
   3. Create at least one manufacturing lot for the devices for Production and Training modes so you can specify their expiration dates, and combine the manufacturing lots into blinded lots if required.
   4. If you're using blinded groups for devices, create blinded groups of kits for devices for Production and Training modes.
7. Throughout the study, perform kit reconciliation for returned devices, if required.