The aim of record keeping and the handling of data is to gather information from the trial without error in a form that can later be analysed and reported. A Case Report Form (CRF) for each patient in the trial must be completed and signed by the investigator and the patient’s files, CRFs and other sources of primary data must be kept for future reference. Patient data must be handled in a way that maintains confidentiality and yet ensures accuracy. All efforts should be made to maintain error-free records.

When subjects are randomized to different groups, the randomization procedure used must be documented. In the case of a blinded trial, a code for the medicine actually administered must be kept under appropriate conditions.