Define the kits for investigational products
When you create kit types, you specify details about the kits, including storage details and whether doses are calculated based on subjects' answers questions. This procedure applies for defining kit types in a rollover study, as well.
If your study has both a blinded and open-label period, you must create separate kit types for the blinded and open-label periods, so the kit type descriptions must be visible to blinded users during the open-label period. If the kit type descriptions don't need to be visible, you can use blinded kit types during the open-label period and need to create only blinded kit types.
If titration is part of your protocol, you might need to create more kit types than you expect.
Here's the rule: you can combine kit types for an up titration or down titration, but only if they're different kit types. In other words, you can't dispense two or more kits of the same type when subjects titrate up or down. Let's say a subject starts at 5 mg and can titrate up to 10 mg. You can create two kit types, 5 mg and 10 mg, and dispense each kit for the appropriate dose. You cannot, however, dispense two 5 mg for the 10 mg dose.
For more information on kit types and their restrictions, see Serialized and non-serialized inventory.
Want to see how to perform this task? Watch the video below.
To create kits for the investigational product:
- Define the dispensation schedule.
- Upload or generate a kit list in Testing mode or Production or Training mode. See Generate or upload a kit list .
A kit list assigns unique numbers to every kit that will be dispensed. After you create a kit list, sponsor and depot users can start managing kits individually.