Case report form (CRF)

The CRF holds what the CIP requires, and every entry has to be traceable to source documents. Electronic CRFs are electronic records and need validated systems with an audit trail.

set of printed, optical, or electronic documents for each subject (3.50) on which information to be reported to the sponsor (3.49) is recorded, as required by the CIP

ISO 14155:2020, clause 3.6