Audits are used to check and evidence that an organisation's quality management system is working (assessment after the event); providing assurances that sponsored research is compliant to the protocol, procedures, GCP, relevant guidelines and/or legislation whilst at the same time identifying any gaps or failures within the system (and where improvements can be made or further training/clarity of process is required).
Audits are conducted by personnel independent of the study team (where the audit is of a site or study activity) and the auditor must be able to demonstrate that they have expertise relevant to the area being audited (for example: if auditing a CTIMP the auditor should be able to demonstrate a sound working knowledge of the current legislation so that they can assess whether the organisation is meeting the requirements of the legislation).