Conduct of Investigator Site Audits in Europe by Clinical Quality Assurance Personnel

Abstract

Guidelines for the conduct of clinical trials have been published through the CPMP. It is likely that these will be made legally binding by European Council Directives. The guidelines require that a system of Quality Assurance allowing for independent auditing of the clinical trial is established by sponsor companies. For many companies this will require establishment of new departments. The auditing of investigator sites where trials are being conducted will also represent a new experience. The rationale for selection of which sites should be audited is discussed. The process of the audit is outlined indicating what documentation should be examined and which other areas need attention. Reporting of the findings and follow-up action is described.