Pause dispensation by placing a dose hold

As a blinded site user or a pharmacist, you have the option of pausing dispensation during a scheduled or unscheduled dispensation visit to ensure a subject's safety.

You can perform a dose hold on multiple types of kits that appear available for this task. Any other kits can then be dispensed to a subject as usual.

To learn more about the particularities of your workflow, see Learn the details of performing a dose hold.

  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 the subject and click the visit in the Next Visits column.
  5. Fill-in the forms. For step-by-step instructions, see Enter data and dispense kits.
  6. Click Dose Hold.
  7. On the Dose Hold dialog, select any of the available types of kits that you must put a dose hold on.

    Note:

    If a dose hold must be placed on an Unblinded Pharmacist type of a kit, you see a notice to contact your unblinded site user or pharmacist, so they can perform this task.
  8. Click Next.
    If there are any other kits to dispense, the Dispense Kits dialog appears.
  9. On the Dispense Kits dialog, review the kit numbers and descriptions.
  10. Verify the subject number in the confirmation window, and note the kit numbers to dispense, any dispensation instructions, and notices about dose holds.
  11. Depending on what is your next step, do one of the following things:
    • Click Close.
    • Click Print Dispensation Information to view and print dosing instructions.
    • Click Return to All Subjects to go back to the Subjects page.
    On the Subject History pane, a kit that was put on hold is displayed as a dose hold.
  12. To dispense a kit that was previously put on hold, look for the kit on the Subjects History pane, click the menu icon (The menu icon is represented by three horizontal lines stacked on top of each other.) and then click Dispense.
On the Subject History pane, a kit that was put on hold is displayed as a dose hold. When multiple types of kits are put on hold, the Subject History pane only displays one dose hold for each type of kit. Upon clicking Dispense, all kit types previously put on hold are displayed. You must select the kit types that you want to no longer hold and plan on dispensing.

Figure 6-3 How a site user sees a kit put on hold in the Subject History pane

A kit put on hold is called a dose hold

Related Topics

Parent topic: Receive and manage an investigational product