ABSTRACT
Case report forms (CRFs) are the forms on which all the information and results of the clinical trial are recorded. Once the patient's involvement in the study is over and the doctor has completed the CRF, it is usually checked on site by the Clinical Research Associate (CRA) and then brought back to the office. The investigator is given one copy and the originals are forwarded to the data management or biometrics department. The information on the CRFs will then be extracted by data-entry staff and entered onto a specially-designed database ready for analysis. It is usual for the CRA to retain a spare copy in case data management personnel identify any queries or omissions. Many CRFs are designed by the CRA responsible for a trial, although larger companies may have a separate department which both designs and produces them. Many CRAs and their secretaries can produce print-ready proofs.
