Set a subject's blinded dose level for kits

Study designers can now specify the dose level for blinded kit type titrations, so site users know whether a subject is on a low, medium or high dose during the study, for example.

Details for study designers

To add labels for a subject's dose level, go to the first column in the Create Kit Type Titration pop-up. Use general terms to describe a subject's dose level without offering unblinding information, so site users know a subject's dose and perform the right dose changes during visits.

Details for site users

Every time you want to perform a dose change for a subject, a label appears on the Dispense Kits wizard. For example, this label can indicate whether the subject is on a low, medium or high dose of the investigational product without unblinding the kits.

After you decide whether to maintain, decrease or increase a subject's dose, the dose label changes in the Dispense Kits wizard.

Reporting changes

Data about blinded dose levels can be seen in the Titration Summary report, Subject Dispensation report, and the Study Design report.

Already working in a live study?

As a study designer, you can start adding dose level titles for blinded kits in a kit type titration as soon as the system upgrade is complete. As a site user, you will see these changes as soon as the updated study is approved and live.