Enhancements for forced randomization

Sponsor users can now set forced randomization limits at multiple levels and create custom enrollment groups using questions from the randomization visit.

Details for sponsor users

• You can now set a maximum number of forced randomizations that can occur in a study.
  • To set a forced randomization limit, use the new Forced Randomization Limits setting in Enrollment Settings on the Study Settings tab.

    Note:

    Subjects force-randomized prior to enabling this feature are excluded from the limit count.
  • Limits can be set at the Study Total, Site Total, Country, and Cohort levels. For more information about these levels, see Specify enrollment settings.

    Note:

    It is not possible to define a forced randomization limit at the individual-site level.
  • Setting a limit defines how many subjects can be force-randomized. For example, if the Randomization Limit is 100 and the Forced Randomization Limit is 10, then up to 10 of the 100 subjects can be force-randomized.
  • Notifications are governed by two settings: Forced Randomization Limits and the Notification percentage. The system displays a notification when the count defined for forced randomizations reaches the specified percentage of that limit. For example, with a limit of six and a notification percentage of 50%, a notification is triggered after the third subject is force-randomized.
• Additionally, the Randomization visit is now available under Select a Visit when creating custom enrollment groups. This allows you to create a group using questions on forms in the randomization visit.

  As with screening groups, the subject limit is recalculated for randomization groups after a group is created. This ensures that previously 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.

  You can use questions on forms from both the Screening and Randomization visits 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.

Details for site users

If a forced randomization limit is met, you are presented with a message informing you of that and to reach out to your clinical research associate (CRA) for assistance.

Impact on reports, extracts, archives, or datasets

More information and specific descriptions on modified report values can be found in the Reporting Guide after the assessment environment upgrade completes.

Report	Type of change	Description
Study Design report	Column name change	The setting Restrict Randomization to Available Kit Types (on the Treatment Arms page in Randomization Design) has been renamed to Restrict Randomization to Available Kit Types (Forced Randomization). This updated label now appears in the Randomizations section of the Study Design report.
Study Settings Report	New column fields	The Enrollment Settings tab now displays the following columns when a forced randomization limit is configured at that level: Forced Randomized Study Total Forced Randomized Site Total Forced Randomized Country Total The Cohort Limits by Cohort tab now displays the following column when a forced randomization limit is configured for a cohort: Forced Randomization Limit
Study Enrollment report	New column fields	A Forced Randomization Limit column now appears in the following sections: General Enrollment Note: Forced Randomization Limits is displayed here. General Enrollment Audit Trail Cohort Enrollment Cohort Enrollment Audit Trail Country Enrollment Country Enrollment Audit Trail