A Screening Eligibility Form (SEF) documents whether a potential participant meets protocol-defined inclusion and exclusion criteria.
SEFs create a traceable record of eligibility decisions and the evidence used to support them (such as lab values, diagnoses, and prior therapy history). Accurate eligibility documentation helps prevent inappropriate enrollment that could increase risk or compromise endpoint interpretation. Monitors frequently review SEFs to confirm adherence to protocol requirements and to identify recurring screening issues. Strong SEF practices reduce protocol deviations and support consistent application of enrollment criteria across sites.