Screening

DEFINITION

• Screening involves a determination of whether potential participants are eligible, i.e., meet all criteria, for participation in a particular study. Screening is the assessment of a potential subject to determine his or her eligibility for enrollment in a clinical study.

Policies/Guidelines

• No subject may be screened without informed consent, unless the informed consent requirement was waived by the Institutional Review Board (IRB).
• Screening and enrollment logs help keep track of study screening. These logs should be maintained in RedCap.

Templates/Forms

• REDCap Shared Library

Training:

• See FDA’s INFORMATION SHEET on Screening Tests Prior to Study Enrollment:
  • Screening Tests Prior to Study Enrollment