Create or edit custom enrollment limits

Study managers can create custom enrollment limits to restrict subject enrollment based on specific criteria. Custom enrollment limits can be defined in all three modes: Testing, Training, and Production.

To make sure you create relevant and appropriate custom enrollment limits in your study, you must work with your study designer to make sure the following elements are defined in a study's design:

• You must include a screening visit in your study. Moreover, you must assign forms to that visit.
• You must include questions with multiple options for an answer, as well as age questions.
• Work with your study designer to make sure that multiple-choice questions, such as checkboxes and drop-down questions, have a Select Exactly One or Answer Must Be validation rules defined.
• Questions on a subject's age must be defined as the specific age type of question.

A custom enrollment group may need to be modified during the study conduct period. For example, if a question used as enrollment criteria is removed or modified, that question is highlighted when you attempt to edit the custom enrollment group. Review the changes and if you still need to use that question for your enrollment criteria, work with your study designer.

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. Scroll down to the Custom Enrollment Settings.
5. Depending on whether this is your first time creating a custom enrollment limit or not, you can:
   • Click Add Custom Enrollment Group to create your first enrollment group.
   • Click the Edit icon () to edit an existing enrollment group.
6. On the Create Custom Enrollment Group dialog, enter the details for the following fields:

   Field	Description
   Group Title	Enter the name of the enrollment group, such as High Risk.
   Subject Limit	Insert the maximum number of subjects permitted for the enrollment group.
   Notification	Enter the percentage of enrollments that generates the Study Limits notification.
   Description	(Optional) Provide additional information about the enrollment group that does not fit in the title.

7. Click Select a Visit.
   The system displays all scheduled visits at or before the Screening visit.
8. From the drop-down, select the appropriate visit, branch, or cycle.
9. Click Select a Form and select a form to display its questions.
10. Drag the desired question and drop it onto the Group Criteria section.
    Repeat this step for every question you want to use as enrollment criteria.
11. Configure the settings of each question for your group criteria.
    For example, for a question with multiple choices, select the exact answer options that must be used as enrollment criteria. Or, for the age question, define the age range of subjects that can be enrolled.
12. Click Save or Save & Add Another.
    The system adds the custom enrollment group to the table.