Specify enrollment settings for minimization cohorts

When specifying the enrollment settings, if your study includes a minimization design , the system displays the cohorts in sections by each minimization design. Typically, a study manager specifies these settings. This procedure also applies to rollover studies.

Each minimization design contains a number of cohorts defined when creating the randomization. Minimization cohorts are organized underneath each minimization design listed in this section. For example, a minimization design called "Minimization 1:1" will have a corresponding section of cohorts on this screen called "Minimization 1:1 Cohorts".

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

1. Open the study settings.
2. Below the study name, click the Study Settings tab.
3. On the top left, select a specific mode:
   • Production Settings
   • Testing Settings
   • Training Settings
4. Within the Enrollment Settings section, locate the cohorts and expand each to fill in the fields:
   1. For each of the displayed cohorts, turn on the toggle to open the enrollment of subjects based for that cohort. Turn the toggle off to close the enrollment for that minimization cohort.
   2. In the Enrollment and Randomization Limits column, enter the maximum number of subjects who can be randomized.
      After this limit is reached, no subjects in this cohort can be randomized (even subjects who were already added to the study). The system then proceeds to randomize subjects from the next cohort included in the minimization.
   3. In the Notifications column, enter the percentage of subjects in the limit who can be randomized before a notification occurs.
      You can adjust this value throughout the study conduct period so that you receive updates about the number of screened and randomized subjects.
5. In the upper right, click Apply Changes, then select an option:
   • Select the option to apply to the given mode.
   • Select Apply to All Modes to use the study settings in all 3 modes.