Complete an unscheduled dispensation visit

During an unscheduled visit, you can dispense kits containing an investigational product, Unblinded Pharmacist kits, devices, perform dose changes or converse and confirm the dispensation of kits, but you can't randomize subjects.To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject.

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 dispense until it is answered.
  • If the question isn't marked as required, you can dispense without answering.

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.

To view dosing instructions, run the Kit Dispensation report. For more information, see Kit Dispensation report.

  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 the subjects list and select the checkbox to the left of it.
    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. From the Manage Subjects drop-down, select Unscheduled Visit, and then choose the unscheduled visit you want to start.
  6. 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.
  7. Answer questions on each form.
  8. Click Save, and then Dispense.
    The button you click to submit the form depends on the type of event associated with the visit.

    Note:

    You cannot dispense to a withdrawn subject. If the subject is in withdrawn state, the dispense button is not available.
  9. Verify the subject number in the confirmation window.
  10. If applicable, click Print Dispensation Information to view the dosing instructions. You can print the report after it opens.
  11. Click Return to All Subjects to return to the list of subjects at the site or click Cancel to remain in the visit.
In the subjects page you can see the visit for the subject:
  • When the visit contains a two-section form, if you completed all of the required questions in the first section of the form and there are no table rows added to the section section of the form, then the two-section form is considered complete. If you completed all of the required questions in the first section of the form, but there are any incomplete rows in the table section of the form, then the two-section form is considered incomplete.
  • The completion of a hidden, required question is taken into account to determine a visit's status, but it won't be taken into account to determine a form's status. To learn more about how a visit's status and a form's status is recorded, see How does a hidden and required question impact a form and visit's status?.

Related Topics

Parent topic: Enter data and dispense kits