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The screening process is a step in the clinical research that occurs before study enrollment. It is used to determine the eligibility of the potential subject for participation in a clinical research study.
The screening process differs from trial to trial based on the eligibility criteria established for the trial. It can include tests or screening questionnaires. As the screening process is considered as a part of the subject selection and recruitment process, it does require IRB oversight.
Source: Office of the Commissioner. (2018, July 13). Screening Tests Prior to Study Enrollment. U.S. Food and Drug Administration. Retrieved January 9, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/screening-tests-prior-study-enrollment