Create or edit a dose hold

As a clinical supply manager, you can create a dose hold to enable site staff to pause dispensation 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.

To create dose holds for multiple kit types, you must create one dose hold for each type of kit. For example, you create one dose hold for a kit containing the investigational product and another dose hold for a kit type titration group.

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:
   • Make sure the toggle () is turned on.
   • Click the toggle () to activate the feature.

     By default, the toggle is turned off.

     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.
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 the edit icon () and edit its details on the Create Dose Hold dialog.
9. To stop the functioning of an existing dose hold, click the toggle () 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.

Activate and create dose holds for other modes in your study, if you haven't already and when required.