Enter data and 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. 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. If the question is marked as required, you can't randomize or dispense until it is answered. If the question isn't marked as required, you can randomize or dispense without answering.

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

For more information on how to handle reference information during the process of collecting data, as well as tips and tricks on how to answer certain question types, see Best practices for collecting data.

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 click 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 Start 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.

   Tip:

   To complete exact times, in the Date & Time wizard, first select Now, and then start filling in the fields with the appropriate time.
6. Answer questions on each form.
7. Click Save and then Dispense.
8. In the Dispense Kits wizard, review details of the kits and click 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, click 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. Click 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, click Print Dispensation Information to view the dosing instructions. You can print the report after it opens.
13. Click Return to All Subjects to return to the list of subjects at the site, or click Cancel to remain in the visit.