Screening

What does Screening mean in clinical research?

Screening is the formal eligibility check that begins after informed consent. The CDISC Glossary's definition of the first-subject-screened milestone places it when the subject signs the informed consent form and is screened for potential enrollment or randomization, before being determined to meet the inclusion and exclusion criteria.^⁠[1] NIH's human subjects office draws the same line: pre-screening happens before a person signs a consent form.^⁠[2]

The distinction matters because screening can include research procedures. FDA's position is that informed consent must be obtained before any clinical procedure performed solely to determine research eligibility, while procedures that are part of routine care and would be done anyway may be used for eligibility without research consent.^⁠[3]

Practical note: every screening visit costs coordinator time, clinic space and patient goodwill, so the fewer candidates who arrive with a disqualifier already in the chart, the better. A records review and a short pre-screening call before the visit, the work of Identify and Engage, can catch many of those.