An audit is an inspection or examination of an organization's records. For the purposes of this office, audits will be a review of an investigator's clinical trial records--regulatory documents, patient study charts and medical records (if applicable).
The intent of the audits conducted by this office is educational. The reviewers are colleagues and peers, the experience is meant to education both the researchers and the reviewers, as well as to ensure the quality and validity of the data collected and reported.
A for cause audit can be conducted by this office. In the case of a for cause audit, the investigator and/or the trial has been brought to the attention of this office, there is evidence for concern and, thus, a pointed audit is warranted.