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 also assign a kit type titration to an unscheduled visit the same way that you would do it for a regular kit.

Note:

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 any 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 the starting dose (first dispensation visit). For step-by-step instructions, see Define kits for titrations and Define the dispensation schedule.

1. Access the Draft version of a study as described in Open a study's design.
2. Select Study Supplies.
3. Select the Kits tab.
4. On the Visits & Events pane, locate the second dispensation visit.
5. Drag a kit type titration to the visit.
   Remember there must be at least one prior dispensation visit in which the starting dose (standalone kit) was added for dispensation.

   WARNING:

   Be careful not to add multiple dispensations of the same kit to the same visit, this includes advanced dispensation, titration and standalone kits. If dispensation of a same kit type is defined more than once in a visit, dispensation will fail.

   For example, a subject may fall into one group of the advanced dispensation that must be dispensed with kit A, while the same visit is configured for kit A titration. In this case, the design must be evaluated and the dispensation schedule updated.

6. Complete the fields on the Add Titration to Visit Schedule dialog and then select Next.

   Field	Description
   Select Treatment Arm	In the field in the upper right, choose the treatment arm(s) that the dose titration applies to. Note: Choosing the All Treatment Arms option for an unscheduled visit won't allow site users to dispense kit type titrations to subjects who aren't randomized.
   Dispense column	Specify when subjects are allowed to titrate. Only visits in which subjects are allowed to titrate appear in the list. To allow subjects to titrate in a visit, select both the Dispense checkbox to the left of the visit and the Allow Titration checkbox at the end of the row. To prevent subjects from titrating in a visit, select the Dispense checkbox to the left of the visit and leave Allow Titration deselected. If titration is allowed in the future as a result of a protocol amendment, this workflow will make your future changes easier.
   DND (Days) column	Enter the minimum number of days before the kit's expiration date that the kit cannot be dispensed to a subject. For example, if the kit has enough product for 30 days, and the patient can come in up to 7 days after the scheduled visit, the DND must be at least 37. Want more help with this field?
   Dispense Outside Window column	Check this column if kits can be dispensed outside the visit window. Site users are notified that a visit is out of window but can still dispense the kits. Leave Unchecked to prevent site users from dispensing to subjects who come in outside the visit window. For an unscheduled visit, you don't see this column.
   Allow Titration column	Instructions on how to complete cells in the column can be found on the Dispense column row, in this table.

7. Complete the remaining pages in the wizard and then select Next. One page appears for each kit type that is dispensed in the kit type titration.
   • In the Quantity field, enter the number of rounds of treatment to dispense in the visit.

     When determining this value, consider the amount of time that will pass before the next dispensation visit and the amount of time that each dispensation visit supplies for. For instance, consider a treatment arm that dispenses 1 bottle of Kit A and 1 bottle of Kit B, and each bottle lasts 1 week. Subjects come in for dispensation visits during Week 1, Week 2, and Week 4. For Week 1, you need to supply the subject with 2 bottles, but the 2 bottles constitute 1 round of treatment, so you should enter 1. For week 2, you need to supply the subject with 4 bottles, which are 2 rounds of treatment, so you should enter 2.

8. Select Finish.
   An icon appears on every visit in which subjects can titrate up or down.

To check the visit configuration, including your changes about titration and dispensation, select the visit in Visits & Events.

• To see or edit dispensation details for a kit or titration on a treatment arm, select the pencil button on a treatment arm. If multiple kit types or titrations are associated with the treatment arm, select one from the drop-down to view its details.

  Note:

  After a kit type titration has been added to a visit, you can only edit the settings for a kit type titration (Dispense, DND, Dispense Outside Window, Allow Titration), and the quantity for each kit type. The same rules apply after a study has been approved.
• To remove the association between a titration and visit, select the trash can for the titration within the given treatment arm.
• To change the visit ID, select the pencil for the corresponding field in the upper-left corner of the visit dialog.
• You can drag and drop to reorder forms or add more forms in a visit using the Add form icon (+), on the Forms pane to the left of the dialog.