An audit is an integral part of this process and ensures the validity of research data from which conclusions are drawn. In order to maintain the integrity of the audit process, auditors are necessarily independent of the sites at which the data is generated. Thus, preparing for an audit, including the preparation of institutional records that verify reported data, is generally the responsibility of the institutional CRA. This preparation is crucial, since questions raised on audit often require a lengthy resolution process that can involve sanctions against the site. The Clinical Research Group is available to prepare the clinical site for a successful audit.