Complete a dispensation visit for devices

You must complete all required fields to be able to dispense devices to a subject during a dispensation visit. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. This procedure applies to rollover studies, as well.

Note:

If you enter data that doesn't meet the requirements specified by the sponsor in the form fields, a message explains why the answer does not meet the required criteria.

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

1. On the Home page, determine where to work. For more information, see Access study modes and pages.
2. Along the top, make sure Subjects is selected.
3. Filter your view based on several criteria. For more information, see Filter subjects in a study.
4. Locate a subject on subjects list, and select the visit in the Next Visits column.
   Upon selecting a subject, you can view whether certain visits in a subject's schedule are part of a branch or what cycle they are on.
5. For the Visit Date field, select today or an earlier date. Depending on how the study is set up, you might be allowed to edit the date after saving the form.
6. Answer questions on each form.
   For more information on specified data points required for certain actions, see About required questions for Randomization and Trial Supply Management (RTSM) events.
7. Select Save and then Dispense.

   Note:

   You cannot dispense to a withdrawn subject. If the subject is in withdrawn state, the dispense button is not available and the visit will remain in incomplete status.
8. In the Dispense Kits wizard, review details of the kits and select Next.
9. Locate the devices to configure for the subject:
   • For a device with a cloud-to-cloud connection, enter the unique vendor code that comes with the device.
   • For a device with a device-to-cloud connection, make sure they're using the right access code and password. If they don't work, select Refresh Codes.

     Note:

     Remember that you can only activate one device with a device-to-cloud connection for a subject in a study.
   • If you need to dispense devices that aren't created through Oracle mHealth Connector, just follow your regular workflow for dispensing devices.
10. Select Finish to dispense the kits to the subject. Just as it happens with investigational product kits, you don't see kit descriptions for devices that are blinded. Instead, you only see the kit type.
11. In the Dispense Kits wizard, verify the subject number.
12. If applicable, select Print Dispensation Information to view the dosing instructions. You can print the report after it opens.
13. Select Return to All Subjects to return to the list of subjects at the site, or select Cancel to remain in the visit.