Subject binder

A binder (or chart) that contains source documents for the research subject, including the original signed Informed Consent Form (ICF)(s), study progress notes, case report form(s) (CRFs), medical records, any required testing results (for example: labs, electrocardiograms, and X-rays), diaries, logs completed by the participant, individual participant study drug logs (if applicable), and more. CITI: Clinical Research Coordinator Foundations Course: Clinical Research Coordinator (CRC) Responsibilities