What is my workflow if subjects need to titrate?

Your workflow depends on whether you titrate according to a predefined schedule, or you let subjects change doses based on input from a clinician at the site.

• If subjects must titrate according to a predefined schedule, you just assign the appropriate kit type to each visit when defining the dispensation schedule.
• If subjects have the option of changing doses based on the input from a clinician at the site, you must define kit type titrations. Use the following workflow when defining the kits in the study:
  1. Define all the kit types.

     Sometimes subjects can titrate the investigational product but don't titrate another kit type, such as a box of syringes or a rescue inhaler. Create kit types for all the products, including those that can be titrated and those that can't be titrated.

  2. Define the kit type titrations.

     If you're dispensing a kit separately, such as the syringes or rescue inhaler, don't include it in the kit type titration.

  3. Define the dispensation schedule.
  4. Associate kit type titrations with the appropriate visits.