Complete a dispensation visit with dose changes

You must complete all required fields to be able to perform dose changes for 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 You cannot dispense to a withdrawn subject.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.
  • 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.

  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.

    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    You cannot dispense to a withdrawn subject. If the subject is in withdrawn state, the dispense button is not available and the visit will remain in incomplete status.
    Option Steps
    If the subject is allowed to titrate
    You can change the subject's dose, so you must select an option:
    1. In the Dispense Kits wizard, review the details and options that you have for dose changes:

      In a blinded study, the subject's number appears; in an unblinded study, the kits that the subject received last also appear.

    2. Select one of the following:
      • To keep a subject on their current dose, choose Maintain Dose.
      • To titrate down, choose Decrease Dose.
      • To titrate up, choose Increase Dose.
    3. Review the message and select the checkbox.
    4. Click Next.

    Note: If either the Decrease Dose or Increase Dose options are grayed out, that type of titration isn't allowed right now. The subject might have reached the limit for the maximum number of allowed dosing changes or not enough time has passed since the subject's last titration. To learn more about visit and dispensation settings, contact your Clinical Research Associate (CRA).
    If the subject isn't allowed to titrate
    You can't change the subject's dose, so a message from the sponsor or CRO appears:
    1. Review the message, and click OK.
    2. In the Dispense kits wizard, do the following:
      • Check the kit details and click Next.
      • To go back and choose a different option for titration, click Back.
  8. In the Dispense Kits wizard, verify the subject number.
    If there are not enough kits available at a site to dispense, Perform a partial dispensation.

    Tip:

    After a partial dispensation, you can do an unscheduled titration to decrease the dose so that the subject doesn't need to come back to receive more kits.
  9. If applicable, click Print Dispensation Information to view the dosing instructions. You can print the report after it opens.
  10. Click Return to All Subjects to return to the list of subjects at the site, or click Cancel to continue operating 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