Screening and randomization limits by site

Study managers can now set limits for sites and report on the defined limits.

With this new feature, study managers can control the number of screened and randomized subjects by site, adding different limits for each site even after the study is live. These limits can be set in all three modes: Production, Testing, and Training. When any of these configured limits are reached during the study, users with the Receive Study Limits Notifications permission receive an alert.

Details for study managers

If you want to manage site limits, here's what's new for you:

• On the Sites & Labs tab, a new Show limits toggle appears. You can turn it on to display the Screening Limits and Randomization Limits columns. If your study does not include randomization, limits defined for screening will be used for enrollment.
• On the Screening Limits and Randomization limits column, you can enter a number to define the limits for each site included in your study. These limits will override values indicated on the study settings, if any.
• You can leave limits undefined or with a null value in a study and this will not affect the study's development.

Figure 6-2 Changes in the Sites & Labs tab to define screening and randomization limits by site

You can find additional information in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Reporting updates

Within the Study Enrollment report, you can find a new section called Site Enrollment that contains the details about site limits. New columns for each site will show as Screening limit and Randomization limit.

You can find additional information in the Reporting Guide after the Release Assessment Environment upgrade.