Abstract: Many computer systems can be used in the diagnosis and care of subjects in a clinical study,in dispensing drug supplies, and in performing laboratory tests required by the study protocol. It is impotant that these systems are closely controlled and perform reliably every time they are used. Intermational regulations require that such systems be well documented. Audits a and inspections at clinical study sites under Good Clinical Practice (GCP) will check such systems to be sure that they are re liable in perfomance and that their data is trustw orthy. The Principal Investigator in a study is responsible for the quality of all computer systems used to meet the study protocol and for the quality and trustworthiness of all trial data collected either by paper or computer.

Key words: computer validation, clinical trial, GCP audit, study site computer, risk analysis, data integrity