Detailed and accurate documentation, source or otherwise, is crucial in clinical research and yet the site monitoring visit report is often perceived as a "B-list" actor when compared with the superstar, source documentation. Nothing could be further from the truth. The monitoring visit report not only documents observations at the site but is one of the main avenues for communicating important information to key stake holders in the clinical research process: study and site issues to the sponsor and facilitating sponsor oversight of the investigator and clinical study; issues of concern and corrective actions to the site staff, and site GCP compliance to regulatory authorities, especially during an audit. The importance of the monitoring visit report must be understood and guidance provided on how to write it effectively.
Roslyn Hennessey, PA, MS, Project Manager, Westat