Automatically selected subjects

Automatically selected subjects are those subjects that are added to the SV Pool based on:

• The number of initial subjects enrolled in the site that you want to be source verified. The default is 0.

  These subjects are added automatically to the Manual Pool, but are otherwise the same as other manual subjects.

• A percentage (0 to 100%) target rate at which you want subjects to be selected for source verification after the initial subjects are verified (the SV Target Rate). The default is 100%, which means all subjects are selected.
  • If you increase the target rate, the auto-selection process only considers subjects from the SV Eligible Pool.
  • If you decreases the target rate, the auto-selection process ranks subjects in the Auto-select Pool for return to the SV Eligible Pool based on the current number of forms already source verified.

    For example:

    If subject 01-004 has one form source verified, subject 01-007 has two forms source verified, and subject 01-012 has three forms source verified:

    • The process returns 01-004 to the SV Eligible Pool if the rate reduction called for removing a single subject.
    • If the rate reduction called for removal of two subjects from the Auto-select Pool, then subjects 01-004 and 01-007 would be returned.

      This occurs so that reduction of the Auto-select Pool maintains a preference for retaining subjects with the highest number of SV Complete forms for the study. This ensures that the least amount of additional source verification work is required when the target rate is reduced.