ABSTRACT

At the end of a clinical trial, after possibly several years of work, the only tangible product is a collection of pieces of paper called case record or case report forms (CRFs). These are the forms on which all the information and results of the clinical trial are recorded. They are designed to match the protocol, be filled in by the investigator, checked by the CRA and the results put onto a computer for analysis. A common source of confusion is that CRF is also used as an abbreviation for case record folder which is a bound ‘book’ of individual forms, sufficient for one trial patient.