Create or edit a dose hold

Create a dose hold to enable site staff to pause dispensation of a specific kit type for a subject due to safety reasons. A dose hold can be created in all three modes: Testing, Training, or Production.

To learn more about the end-to-end workflow of creating and applying dose holds, as well as any particularities of this feature, see Understand how dose holds work.
Activate and create dose holds for other modes in your study, if you haven't already and when required. To create dose holds for multiple kit types, you must create one dose hold for each type of kit individually:
  • If your study allows titration, you can create one dose hold for a kit containing the investigational product (kit types used in the titration definition) and another dose hold for a kit type titration group.

    Note:

    The dose hold created for the titration group takes precedence over the dose hold created for the individual kit type, if both are defined.
  • If your study uses advanced dispensation, dose holds must be defined on the individual kit type used in the advanced dispensation definition, as multiple kit types can be defined for multiple groups.
To create or edit a dose hold:
  1. Open the study settings.
  2. Click the Supply Settings tab.
  3. On the top left, select a specific mode:
    • Production Settings
    • Testing Settings
    • Training Settings
  4. Scroll down to the Dose Hold Settings and depending on whether this is the first time you are creating a dose hold or not, you can:

    Note:

    You cannot set to have partial kit dispensations and dose holds at the same time in your study. If you activate either of the toggles, the other one will be deactivated.
    • Make sure the toggle The toggle is turned on and colored in blue. is turned on.
    • Click the toggle The toggle is turned off and grayed out. to activate the feature. By default, the toggle is turned off.
  5. Click Create Dose Hold.
  6. On the Dose Hold dialog, fill-in the fields:
    Field Description

    Kit Type or Titration Group

    From the drop-down, choose the kit type or titration group that sites can pause dispensation for.

    Starting Visit

    From the drop-down, choose the visit where site users can begin performing dose holds for the previously specified kit type.

    Note: On this drop-down, while you may see the randomization visit in your study available for selection, remember that a site user cannot place a dose hold during a randomization visit.
    End Visit If you set an end visit date, dose holds will not be able to occur past this visit.

    Cycle

    If you chose a visit from a branch, for the Starting Visit field, a new Cycle field appears. You must choose the cycle where site users can begin the dose holds.

    Max per Subject

    Enter a whole number (from 1 to 999) for the maximum number of dose holds that site users can perform for the selected kit type.

    Leaving the field empty sets the maximum number of dose holds to unlimited.

    Frequency per Subject
    Choose whether there is a limited frequency or timeframe during which the site user can perform a dose hold:
    • Unlimited
    • Up to a certain number of sequential dose holds: enter a whole number from 1 to 999.
    • Every certain amount of days: enter a whole number from 1 to 999.
  7. Click Submit & Create Another or Create.
  8. To edit the details of an existing dose hold, click Edit Edit and edit its details on the Create Dose Hold dialog.
  9. To stop the functioning of an existing dose hold, click the toggle The toggle is turned on and colored in blue. next to a dose hold to deactivate it.
Every dose hold that you create is displayed in a table, in the Dose Holds Settings section, along with the dose hold's corresponding details, such as the chosen kit type, the starting visit, as well as the allowed number of dose holds per subject, and the frequency.

Related Topics

Parent topic: Define settings