Understand how dose holds work

Dose holds are crucial when an investigator needs to pause dispensation and respond appropriately to subjects' experiences concerning their health and well being. To make sure this feature is properly configured in a study, several types of users must do their part in creating and applying a dose hold.

What clinical supply managers must know

As a clinical supply manager, it is your responsibility to properly configure dose holds for one or all required kit types in a study. How a site user performs a dose hold during the study conduct period depends entirely on what you allow them to do.

Before you begin your work with dose holds, there are several particularities of this feature that you must consider to make sure you approach your task in the right way.

You can choose to create one or more dose holds in your study, in any study mode (Testing, Training, or Production) and properly define the details of each dose hold. For step-by-step instructions on how to create and manage a dose hold, see Create or edit a dose hold.

Consideration	Notes
Kit types	You cannot define more than one dose hold for the same combination of a visit and kit type. For example, you cannot create two separate dose holds for Kit A, starting with a Week 1 visit. If you already created a dose hold for an individual kit type titration within a titration group, but also created a dose hold for an entire titration group, the dose hold created for that titration group takes precedence over the dose hold created for the individual kit type. A dose hold created for a titration group is always taken into account, even when a dose hold for an individual kit type is not created separately.
Visits	You cannot create a dose hold for an unscheduled event or a randomization visit. However, you can create a dose hold for an unscheduled visit (that is different from an unscheduled event, such as an Adverse Event). An end visit date can be entered for dose holds.
Frequency of dose holds	When establishing the frequency of dose holds, keep in mind that, in the application, days are considered calendars days and not increments of 24 hours. Days are determined by a site's current time zone.
Avoiding unblinding	If you are creating a dose hold for an Unblinded Pharmacist kit, work with your study designer to make sure there is a matching placebo kit that you can use to configure the dose hold. You must know that kits available for dose holds are displayed using an icon for the site user to match the kit that they want to put on hold. If the kits that can be put on hold are using the same icon (for example, the Blister pack icon), and if multiple blinded kits must be dispensed to a single treatment arm, these similar kits are grouped using one dose hold icon. See figure below.

Figure 4-2 How a site user sees blinded kits available for dose holds

What the site staff must know

If you want to learn more about what a site user must do to pause dispensation, see Pause dispensation by placing a dose hold.