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.

Want to see how to perform this task? Watch the video below.

To create kits for the investigational product:

1. Access the Draft version of a study as described in Open a study's design.
2. Click Study Supplies.
3. Click the Kits tab.
4. Click Create Kit Type and then click Investigational Product.
5. For Calculating Doses, choose Yes if you need to define calculations for this kit type based on subjects' answers to one or more questions. Choose No if calculations aren't required for dispensation.
6. Fill in the remaining fields and click Add.
   To view tips for completing a field, click into the field or choose an option.

   Field	Description
   Distribution Settings	Note: This field has unblinding consequences. Make sure you set it correctly. If blinded users should never see the kit type description, choose Blinded. If blinded users should always see the kit type description, choose Unblinded. If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types, choose Unblinded Pharmacist. You typically choose this option for kit types that contain an investigational product that should be prepared by a pharmacist or an unblinded site user.
   Kit Type ID	Enter an identifier for the kit, such as A.
   Description	Enter the name of the product. If the kit type is unblinded, make sure the description is appropriate for blinded users.
   Storage Temperature	Choose the storage temperature requirements for kits of this type (ambient, refrigerated, or frozen). If you're not sure, work with the clinical supply manager.
   Type	Choose the packaging of the product. This selection determines the image that appears for the kit type.
   Minimum Units to Ship	Enter the minimum number of kits to include in each shipment to meet packaging requirements. For example, for a box of 6 individually labeled vials, the value is 6.
   Single Unit Dose	Specify how one unit in the kit is measured, both its value (such as 10) and its measurement (such as mg). The Single Unit Dose value should correspond to the minimum dose of the product. Note: When you multiply the Single Unit Dose value by the Units Per Kit value (described below), the answer must match the total value of the kit. For instance, if a kit contains 50 mg of a product and has 10 pills, the Single Unit Dose is 5 mg (50 mg / 10).
   Units Per Kit	Enter the number of units in the kit, such as the number of pills in a bottle.

Adding kits to your study is a multi-step process. After defining the kit types, you must:

• 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.