Complete a randomization or dispensation visit

During a site visit, you collect data as required using the forms associated with the visit. You may also randomize a subject or dispense a kit as part of the visit. To randomize or dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject.

You must complete all required fields to be able to dispense or randomize. 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.

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.

WARNING:

If your study is set to randomize upon kits availability you may get an error if the required kits are not available at the site. Make sure all your shipments are marked as received and kits are added to inventory with a status of Available, then try to randomize the subject again. See Randomize a subject after Oracle Clinical One Platform didn't allow you to randomize.

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 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 complete the visit:
    • If the visit doesn't include randomization or dispensation, clicking Save marks the visit as complete.
    • If you want to save your changes and randomize or dispense later, click Save & Close.
  8. Next, do one of the following:
  9. In the Dispense Kits dialog, verify the subject number.
  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