Screening and Enrolling Subjects
Subject screening and enrollment are two distinct processes that go hand in hand. The screening process evaluates potential participants for their eligibility to take part in a study. The enrollment and randomization processes register participants into a clinical trial, assigning them to the appropriate treatment arm, as applicable.
Subject screening takes places before enrollment to ensure that potential subjects meet all enrollment inclusion and exclusion or eligibility criteria. Often times existing clinical data may be used, if within window, in combination with other data for enrollment. A subject screening log is an essential document recording subjects who were reviewed for possible entry into a clinical trial they were "screened" for entry and why they were or were not eligible. Documentation of eligibility is very important.
Enrollment is the active of enrolling someone onto the trial. From that point on they will follow the clinical trial protocol. For the purposes of the Penn IRB, enrolment means consenting. Any subject who signed consent, is enrolled.