Glossary
Pre-screening
Checking whether a person might qualify for and want to join a study before they sign consent, through a records review or a short conversation.
What does Pre-screening mean in clinical research?
Pre-screening covers the steps before informed consent that decide whether someone might be eligible and interested. NIH's Office of Human Subjects Research Protections describes it as happening before a person signs a consent form, to see if someone might qualify and is interested in the study, and says it must not include research procedures; screening to determine further eligibility happens after consent.[1]
Under the revised Common Rule, an IRB may approve obtaining information for screening, recruiting or determining eligibility without consent when the investigator communicates with the prospective subject or accesses records.[2] Pre-screening is also where many interested patients are lost: a 2024 DIA Global Forum article cites an estimate that 69% of patients identified and interested in participating are never pre-screened.[3]
Practical note: keep a pre-screening log of who was reviewed, contacted, eligible for a screening visit, or ruled out and why, and follow your IRB's rules on what identifiable data you may keep for people who do not qualify. See the pre-screening call script, and Engage for voice and text pre-screening.
Sources
- 1.Screening for Research Studies · NIH Office of Human Subjects Research Protections, 2026Quote: "Pre-screening happens before a person signs a consent form. Its purpose is to see if someone might qualify and is interested in the study." Also: "It must not include research procedures." and "Screening to determine further eligibility happens after consent is obtained (unless waived by the IRB)."
- 2.45 CFR 46.116(g) Screening, recruiting, or determining eligibility · eCFR (HHS OHRP), 2026
- 3.Documenting the "Last Mile" Leak in the Patient Recruitment Pipeline · DIA Global Forum, 2024Quote: "69% of patients identified and interested in participating are never pre-screened" (the article attributes this figure to Clinical Leader).