|Audits, part of quality assurance, may be initiated by the sponsor during or following completion of a clinical trial. Audits are conducted regularly or because of special events. The sponsor will announce an audit visit a few weeks in advance. Normally, the clinical monitor (clinical research associate – CRA) will assist the investigational site in preparing the audit and will also be present during the audit.
In accordance with ICH-GCP, an independent auditor is sent to an investigational site to verify whether the trial is/was conducted in accordance with applicable laws, GCP, protocol and SOPs. Furthermore, it is validated whether the data have been collected in accordance with these requirements. In a final discussion, the auditor will explain findings (categorised as minor, major, critical) to representatives of the study team. The sponsor will receive an audit report from the auditor summarizing any findings.
Following the audit, the investigator will implement a so called CAPA plan (corrective and preventive action plan), which must be communicated to the entire study staff and rolled out within an individually chosen period of time. Hence, a well organised audit follow-up can contribute to increasing the study quality at the audited study site.
Apart from on-site audits, authorised Contract research organizations (CROs) or the sponsor themselves may be audited.
Another possibility for external examination of investigational sites is an inspection. They follow a similar scheme as audits but are requested by the responsible governmental authority and not by the sponsor.