Create or edit custom enrollment groups

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

Study design requirements

Work with your study designer to ensure the following elements are defined in the study design so you can create the appropriate custom enrollment groups:

• Screening or randomization visits that include forms and questions that are needed to create a group.
• The questions must include multiple options.
• Multiple-choice questions, such as checkboxes and drop-downs should have a Select Exactly One or Answer Must Be validation rule defined.
• Questions on a subject's age must be defined on a form using the Age type question. For more information, see Specify details for an age 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.

Details about combining screening and randomization criteria in a group

Questions on forms from both the screening and randomization visits can be used when creating groups.

• If the same data is collected at both visits, like weight at screening and randomization, you can only use one question in the group.
• If a group contains only screening-visit questions and the subject limit is reached, you cannot screen additional subjects. Likewise, if a group contains only randomization-visit questions and the defined limit is reached, you cannot randomize additional subjects.
• If a group is created using questions from both screening and randomization forms that are part of the screening visit, and the subject limit is met, you cannot screen or randomize additional subjects.
• If a group is created using questions from both screening and randomization forms that are part of different visits, and the subject limit is met, you cannot randomize additional subjects.

1. Open the study settings.
2. Below the study name, select 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 group or not, you can:
   • Select Add Custom Enrollment Group to create your first enrollment group.
   • Select Edit () 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. Note: Subject limit is only calculated when the criteria are met and custom enrollment is enabled. If the criteria are met while custom enrollment is disabled or not configured, those subjects will not be included in the subject limit calculation.
   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.
   Enabled	Indicates whether the enrollment limits are applied or not.

7. Choose Select a Visit, then select the appropriate visit.
   The drop-down includes all visits prior to screening, as well as the screening and randomization visits themselves.
8. Choose Select a Form, then select a form to display its questions.
9. 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.
10. 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.
11. Select Save or Save & Add Another.

    Note:

    The subject limit is recalculated after a group is created. This ensures that previously screened and randomized subjects are taken into account when calculating the subject limit for a group. You may notice a brief delay before the change appears in the interface—updates are usually complete within about ten minutes.