Monitoring in clinical trials

Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. Oversight of the monitoring activity is the responsibility of the sponsor. According to the U.S. Food and Drug Administration's Center of Drug Evaluation and Research, the top five deficiency categories for site inspections caught by clinical monitors as reported in the 2001 Report to the Nation are: Failure to follow investigation protocol (the procedures and treatment subjects must undergo, as well as the schedule of assessments) Failure to keep adequate and accurate records Problems with the informed consent form Failure to report adverse events Failure to account for the disposition of study drugs Therefore, the primary goal of clinical trial monitoring is to observe each trial site to ensure that the standardized operation procedures for the trial are being followed, reporting and managing any deviations from the investigation plan as they occur. Monitoring plans in the United States typically also require a clear protocol for reporting adverse/undesirable effects caused by the treatment to the institutional review board (IRB), the US Food & Drug Administration (FDA), and the institution funding the research.