ABSTRACT
This chapter discusses the role of the auditor during random, planned audits and how they can maximize their effectiveness in detection and analysis of possible fraud or misconduct at an investigator site. The auditor is a key member of the team in assessing the trustworthiness of scientific and medical researchers, which is essential to ensure that public confidence in clinical research is maintained. Site audits are especially effective in ensuring the quality of the clinical procedures performed – usually by people who are not under the direct control of the sponsor. Audit reports typically have limited circulation, to minimize any possible misinterpretations that may affect the auditees. Audits will only be effective with successful and timely follow-up. The follow-up process must be well structured and controlled. At the end of the audit process, audit certificates are issued for site audits.
