Specify enrollment settings

Define enrollment settings to manage limits and notifications for screening, randomization, and forced randomization in your study. We recommend configuring and verifying them in Testing mode first.

You can change limits at any time. However, when you set enrollment limits, consider the following:
  • Limits defined on the Sites & Labs tab will override values set in Enrollment Settings table. See Manage screening and randomization limits by site.
  • Subjects from all study versions for a particular study count toward the limits.
  • For studies where subject numbers are assigned after screening, enrollment limits reached at either the study, country or site level, block site users to start screening candidate subjects.

Tip:

You don't need to specify limits for every field. Setting limits on many levels can sometimes result in randomization errors that are difficult to troubleshoot.
  1. Navigate to the Study Settings tab and determine in which mode you want to work. For step-by-step guidelines, see Specify study, enrollment, and visits settings.
  2. Under Enrollment Settings, configure the enrollment settings appropriately:
    Setting Description
    Study Total Specify limits for the entire study.
    Site Total Specify limits for sites. All sites are subject to the same limit.

    Note: If you want to set screening and randomization limits individually by site, select View Sites to go to the Sites & Labs tab. For more information, see Manage screening and randomization limits by site.

    Forced randomization limits cannot be set at the individual site level.
    Country Specify limits that every country is subject to or create country-specific limits. To specify country-specific limits, select Add Countries, select your countries, and then enter limits for them.
    Cohorts

    Note - Only the studies that use a randomization type that requires cohorts will display this field.

    Specify a limit for each cohort.

    You must select the Cohort checkbox to enable or disable the Stratum checkboxes individually.

    Want to know how to open and close a cohort?
    Stratum

    Only displays for studies that use a stratified randomization type that requires strata and have previously defined cohorts.

    Specify limits for each stratum.

    You must select the Cohort checkbox to enable or disable the Stratum checkboxes individually.

  3. For each row, select the check boxes in the column First Screened Notification or First Randomized Notification, to activate the alerts respectively.

    Note:

    Activating notifications for specific screening and randomization limits or events isn't enough. Users need to have the appropriate permissions assigned to receive these notifications. For more information, see Subject notifications.

    There are no subject notifications for forced randomization limits.

  4. For each activated row, fill in the values for the following:
    Setting Description
    First screened notification

    Select the check-box if you want to receive information about the first screened subjects for either a study or a site.
    First randomized notification

    Select the check-box if you want to receive information about the first randomized subject for either a study or a site.
    Screening Limits

    Enter the maximum number of subjects who can be screened. Screen failures count toward this limit.

    After this limit is reached, sites can't add any more subjects.

    If you want to limit only randomization, for example, you can leave the Screening Limits fields blank.

    Randomization Limits

    Enter the maximum number of subjects who can be randomized.

    After this limit is reached, no subjects can be randomized (even subjects who were already added to the study).

    If you want to limit only screening, for example, you can leave the Randomization Limits fields blank.

    Forced Randomization Limits

    Enter the maximum number of subjects who can be force randomized.

    After this limit is reached, no subjects can be force randomized.
    Notification %

    Enter the percentage of subjects in the limit who can be screened, randomized, or force randomized before a notification occurs.

    The notification percentage that you specify applies to the screening, randomization, and forced randomization limits.

    You can adjust this value throughout the study conduct period so that you receive updates about the number of screened, randomized, and force randomized subjects.
    Cap

    Note: Only displays for studies that include stratification randomization design with strata within cohorts.

    Specify the maximum amount of subject in a stratum.
    Notification Percent (%)

    Note: Only displays for studies that include stratification randomization design with strata within cohorts.

    Enter the percentage of randomized subjects in the cap for each stratum.

    After this limit is reached, a notification is sent.
  5. If your study includes a minimization design with cohorts, specify enrollment settings for minimization cohorts that have been created in study design.
  6. Select Apply Changes:
    • Apply to Production to use the study settings only for your approved study.
    • Apply to All Modes to use the study settings in all three modes: Testing, Training, and Production.

Related Topics

Parent topic: Specify study, enrollment, and visits settings