Allow subjects to titrate up and down
You can now design a study that allows subjects to titrate up or down - that is, increase or decrease their dose levels - based on input from a clinician at a site. Starting with this release, when subjects titrate, they must switch to a different kit type for the same investigational product, such as moving from a 5 mg kit type to a 7.5 mg or 2.5 mg kit type.
Titrating by changing dosing frequency, such as consuming more or fewer pills per day, isn't supported in this release.
Titrations are an optional feature. If the study that you're working on doesn't allow subject titrations, your workflows won't change, though you might still see small interface changes. For instance:
- If you're a study designer, you'll see the button for creating kit type titrations, and there are some small changes to fields when you define the dispensation schedule.
- If you review some reports, you'll see some new fields related to titrating.
A couple more things you should know about titrations before you keep reading: In this release, when a kit type has calculated doses defined for it, the kit type can't be titrated. And subjects can't titrate during unscheduled visits.
Ready to learn more? Keep reading for all the details about this great new feature.