Manage screening and randomization limits by site

Study managers can set screening and randomization limits for each site individually.

When managing screening and randomization limits, users can either set site limits for the total of sites at once or for individual sites. SeeSpecify study, visit, limit, and cohort settings for more information on setting total limits.

Users must consider the status of the site when setting limits. For example, active sites can have limits, but retired site cannot, However, subjects from retired sites will still count toward the overall limit for study totals.

1. Open the study's settings.
2. Select the Sites & Labstab.
3. On the top left, select a specific mode:
   • Production Settings
   • Testing Settings
   • Training Settings
4. Turn on the Show Limits toggle, in the upper right corner of the screen, to show the limits columns.

   Note:

   When toggle is off, no specific limits are considered for sites.
5. If the Screening and Randomization Limits toggle is not visible in the Study Settings page Check the sites' permissions and make sure the Randomize Subjects toggle button is enabled for every site. If this toggle is disabled, it will prevent you from randomizing subjects at the given sites. For more information, seeManage site permissions.

   Figure 4-1 Sites & Labs tab - Screen and randomize subjects toggles

   
   

   

   
   
6. Enter a number for the Screening Limit and Randomized Limit in the appropriate column and for each site as required.

   Note:

   As long as you define the randomization for a study version in each mode, both the Screening Limit and Randomized Limit columns will be available for sites in all modes: Testing, Production, or Training. You will see only the Screening Limit column if you don't have defined randomization in any study version for the given mode. To add a randomization list, see Generate a randomization list.
7. Click Apply Changes.