Define kits with calculated doses

When you create kit types for the investigational product, you can choose whether calculated doses should be included or not, along with other storage details.

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.

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

If you don't want to create a kit with calculated doses, follow the simplified procedure. For step-by-step instructions, see Define the kits for investigational products.

To create kits with calculated doses:

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 to define calculations for this kit type based on subjects' answers to one or more questions.
6. Fill in the remaining fields and click Next.

   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.

7. Click the edit icon () to the right of Calculated Dose 1, and specify a name for the calculated dose.
   If you create multiple calculated doses for a kit type, make sure you use names that help you distinguish them.
8. Fill in the fields and click Finish.

   Field	Description
   Form Question for Calculated Doses	From the drop-down on the left, select the form containing the question that is used to calculate the appropriate dose for each subject. From the drop-down on the right, select a question. The answer to the question is used to calculate the appropriate dose. Only required Number questions are listed.
   Visit Where Form is Collected	From the drop-down on the left, select the type of visit that contains the question for the dosing calculation. If the question is asked in multiple visits and you want the calculation to use the subject's answer from the visit that they're currently in, choose Current Visit. From the drop-down on the right, select the visit in which the question that is used to calculate the appropriate dose is asked.
   Precision for Each Dose	Choose the number of places after the decimal point that each dose should be calculated in. For example, choose 1 if the calculation should round each dose to the nearest whole number Choose 1.0 to round each dose to one number after the decimal and so on.
   Round Up For	Determine how rounding is performed to reach the dose precision that you specified. For example, if the precision is 1, and the dose calculation is 2.483, should that number be rounded up to 3 or down to 2? Choose .4 if all numbers above .4 round up to the nearest whole number.
   Dosing Frequency	Determine how many doses the subject must consume: Once: 1 dose per visit. QD: 1 dose per day. BID: 2 doses per day. TID: 3 doses per day. QID: 4 doses per day. Q3: 8 doses per day consumed at 3-hour intervals. Q4: 6 doses per day consumed at 4-hour intervals. Q8: 3 doses per day consumed at 8-hour intervals. Q12: 2 doses per day consumed at 12-hour intervals. Q24: 1 dose per day consumed at the same time every day. Bedtime: 1 dose per day consumed just before bed. With meals: 3 doses per day consumed at mealtime. With meals and at bedtime: 4 doses per day consumed at mealtime and just before bed.
   Use Leftover Units in Next Dose	Select Yes if any units remaining after a dosing round will be consumed during the next dosing round. This option minimizes waste; for example, if a subject consumes only half the pills in a bottle during one dosing round, the calculations assume that the subject will consume the remaining pills in the next dosing round. Select No if you want the calculation to provide a new kit to each subject in every dosing round.
   Kit Measurement	Enter the total numeric value for the product in the kit. For example, if a bottle contains 750 mg of pills, enter 750. The Measurement unit that you specified on the previous page of the wizard, such as mg, is a read-only value below the entry field.
   Subject Measurement	Enter the value that, along with the answer for the subject and the value of a single unit, determines the dose. For instance, if a unit is 10 mg and a subject weighs 150 lb, and you enter 50 lb, the dosing calculation divides the subject answer by the value you enter here and then multiplies that value by the measurement of a single kit (that is, 150 lb divided by 50 lb is 3, and 3 times 10 mg is 30 mg, so the subject’s dose is 30 mg). The unit from the kit type appears as a read-only value below the entry field.

9. To create another calculated dose on the kit type, click the plus sign in the upper right.

If you make a change that breaks the calculated dose (for instance, if you delete a question that is used in a calculated dose), the icon for the calculated dose on the kit type turns red (). If the study hasn't been approved yet, open the kit type and locate the field outlined in red, and then make the appropriate update. For details about what to do if the study has already entered the study conduct period, see Update a form during the study conduct period.

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.