Create titrations with calculated doses

Study designers can now create titrations that include kits with calculated doses.

With the introduction of this feature, studies with dosing calculations can now allow site users to adjust dosage in dispensation visits. Titration is defined in study design and it can now include both standard kit types and kits with calculated doses.

Details for study designers

When you create titrations, here's what's new for you:

• The Create Kit Type Titration button is now called Create Titration.
• On the Create Titration dialog, you can add standard kit types or kits with calculated doses. For kit types that contain calculated doses, a sub-menu is displayed so you can select the exact dose within the kit type that should be used to titrate.

  Note:

  You must specify a dose for every column in a titration: Starting Kits, Down Titrate, Maintain, and Up Titrate.
• On the Settings page in the Create Titration dialog, when you specify the Minimum Time Between Dose Changes to either up or down titration, a checkbox becomes available to enable exceptions. These exceptions allow you to define overrides for the defined time between dose changes.
• If you enable exceptions, a new step in the Create Titration dialog allows to configure exceptions, one step for Up Titration Exceptions and another one for Down Titration Exceptions. On these new sections you will enter a new Minimum Time Between Dose Change for a particular starting and ending dose combination.
• On the Kits tab, when you hover over a titration with calculated doses, you can view the exact doses that are selected for all titration options.
• A calculated dose that is used in a titration can be edited but not removed. If you make an update, the system informs you of the impact of your changes on existing titrations within the study. Also, when a form or visit that is used in the design of a calculated dose is removed from the study, that calculated dose is highlighted as broken () within both the kit type and the titration.

To create titrations with alculated doses in an existing study, you must create the new titration and add it to the dispensation schedule in a draft version and then make the updated study version live. For step-by-step instructions, see Update the way that subjects titrate during the study conduct period.

You can find additional information in the Study Designer User Guide after the Release Assessment Environment upgrade.

Details for site users

There is no impact on the dispensation process, besides you gaining the ability to titrate kits with calculated doses. The process to complete a dispensation visit with dose changes has not changed either. For more details on how to dispense kits with dosage titration, see Complete a dispensation visit with dose changes.