Patient Recruitment
Screening Visit
A screening visit is the in-clinic assessment at which a potential clinical trial participant is formally evaluated against the protocol's inclusion and exclusion criteria, typically through medical history, physical examination, lab work, and protocol-specific tests.
Screening visits begin only after written informed consent. The visit produces an eligibility determination; participants who pass are randomized (or assigned to treatment), while those who fail are recorded as screen failures with the failing criterion captured for the CSR's disposition flow diagram.
AI pre-screening tools reduce wasted screening visits by surfacing only high-probability candidates and quoting the supporting EHR evidence to coordinators in advance.
Related terms
Screen Failure Rate
The screen failure rate is the percentage of patients who consent to be screened for a clinical trial but are subsequently found ineligible and not randomized.
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria are the protocol-defined conditions a person must satisfy (inclusion) or not exhibit (exclusion) to be eligible to enroll in a clinical trial.
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