THE AUDIT VISIT TO THE SITE

The audit visit team consists of at least three people, two of whom are representatives from the DMC. The others are clinical monitors appointed by the Clinical Management Center. The clinical monitor assigned to the local center is not allowed to be a part of the audit team, thus avoiding a potential conflict of interest. At least half of the members of the audit team are experienced, having participated in a previous audit. In this way, experience gained in previous audits is passed on.
During the audit, the site is assessed for general organization, security, and adherence to the study protocol. High priority is given to verification of patient eligibility and informed consent, assessing the quantity and quality of patient progress notes and source documentation, and checking for consistency between the study database and the CRFs at the site. An exhaustive review is made of the study materials for approximately 10% of the patients randomized to that site. These patients are chosen by the staff of the DMC, and are not revealed to site personnel before the visit.
We are careful to emphasize that the audit process is not meant to be hostile. Our purpose is to document a high quality of data collection and follow up of patients. To make the process as nonconfrontational and fair as possible, the site to be audited is contacted 14-30 days before the visit to arrange a mutually acceptable time. After the visit, the audit team writes a report of their findings. This report is then discussed with site personnel, and usually requires corrective actions to be completed.
Our goal is to conduct an unannounced audit of every site that randomizes 20 or more patients. Thus far, 28 sites have been audited and there are six to eight sites remaining. A significant part of the audit is one of three summary designations that is assigned (by the audit team) to the site: 'satisfactory', 'needs improvement', or 'unsatisfactory'. To date, no site has been given an 'unsatisfactory' designation, but three have been given a 'needs improvement' designation. These three sites had significant problems implementing the study protocol, and were eventually closed to patient recruitment.
Along with providing the usual quality control measures, the audits have been valuable as an educational tool, helping us to identify and address situations before they become serious problems. In addition, many site personnel view the audits as an opportunity to reinforce the information contained in the study procedure manual