Define the Study Characteristics

You can model single or multiple treatment arm trials, using either parallel or cross-over designs.

Your edit mode determines which fields are displayed and available to override to enter a different value than the default value provided.

1. On the Treatment tab, in the Study Characteristics section, select the Trial Design:
   • Parallel—A parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then the results are compared.
   • Crossover— In a crossover trial design, each subject receives all defined treatments, but in a different order or sequence; such as, the subjects or patients cross over from one treatment to another during the course of the trial.

     If you select Crossover, you are prompted to enter in additional crossover-specific assumptions such as characteristics about the washout period.

2. From the Measure enrollment periods in drop-down list, specify how to measure enrollment periods. Choose between weeks and days to specify the enrollment period duration interval unit per treatment.

   Note:

   This field and other enrollment-specific fields are hidden for Phase I (Healthy Volunteers) plans because all subjects are assumed to enroll on the same day they arrive at the Clinical Pharmacology Unit (CPU).
3. From the Measure treatment duration in drop-down list, choose between weeks and days to specify the treatment period duration interval unit per treatment.
4. Complete the next section to define the investigator grants.