Specify when subjects can titrate
Perform this task only if the protocol allows subjects to titrate based on input from a clinician at the site. This procedure also applies to rollover studies.
You can assign a kit type titration to an unscheduled visit the same way that you would do it for a regular kit.
You can't drag a kit type titration to the first dispensation visit. You must dispense without titration for the first dispensation visit, and then you can allow titration starting at the second or later dispensation visit. Additionally, you can't drag the kit type titration to the randomization visit, the study completion visit, the withdrawal visit, or a scheduled visit that hasn't been scheduled yet.
To perform this task, you must first create kit type titrations that determine how subjects can change dose levels and define the dispensation schedule. For step-by-step instructions, see Define how subjects titrate and Define the dispensation schedule.
To specify when subjects can titrate:
- To check or change the work you did on a visit, click the visit in Visits & Events.
- To see details about dose changes, point to the kit type titration that's in the box for a treatment arm.
- To edit the dispensation schedule for individual kit types, click the plus sign (+) for the treatment arm.
- To edit the dispensation schedule for kit type titrations, click
the edit icon on the treatment arm.
After a kit type titration has been added to a visit, you can edit only the name and settings for a kit type titration, and you can't delete the kit type titration. The same rules apply after a study has been approved.
- If a study has been approved, you can update the name and settings for a kit type titration
- To remove a kit type titration from a treatment arm, click the trash can for the kit type titration.