The process of setting up screening and randomization limits and statuses

Before you add regions, countries, and users to the study, you must:

Set screening and randomization limits for the study and its regions and countries.
A screening limit is the maximum number of potential subjects who can be screened for a study, region, or country. A randomization limit is the maximum number of subjects who can be randomized into a study, region, or country.

Each study places maximum limits on study populations.
Open or close screening and randomization for the study and its regions and countries.
Screening status determines whether studies, regions, or countries can screen potential subjects. If screening is open, potential subjects can be screened. Randomization status determines whether studies, regions, and countries can randomize subjects. If randomization is open, subjects can be randomized.

Even if study-level screening is open for the study, you must still open the screening limits for individual countries and the regions where those countries are located. If the screening limits are not open in a country and region, sites in that country and region cannot screen potential subjects.