Specify enrollment settings

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

Tip:

You don't need to specify limits for every field and in fact probably don't want to. Setting limits on many levels can sometimes result in randomization errors that are difficult to troubleshoot. You can change limits at any time.

Note:

Consider the following notes:
  • Limits defined on the Sites & Labs tab will override values set in Enrollment Settings table.
  • Subjects from all study versions for a particular study count toward the limits.
  • 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.
  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 Can be changed anytime during the study conduct period Description
    Study Total Yes Specify limits for the entire study.
    Site Total Yes Specify limits for sites. All sites are subject to the same limit.
    Country Yes 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 Yes

    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 Yes

    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.
  4. For each activated row, fill in the values for the following:

    Note:

    If you want to add 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.
    Setting Can be changed anytime during the study conduct period Description
    First screened notification Yes

    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 Yes

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

    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 Yes

    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 randomization, for example, you can leave the Randomization Limits field blank.

    Notification % Yes

    Enter the percentage of subjects in the limit who can be either screened or randomized before a notification occurs. The notification percentage that you specify applies to both the screening and randomization limits.

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

    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 (%) Yes

    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