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TransCelerate has developed a risk-based monitoring methodology that transforms clinical trial monitoring from a model rooted in source data verification (SDV) to a comprehensive approach leveraging cross-functional risk assessment, technology, and adaptive on-site, off-site, and central monitoring activities to ensure data quality and subject safety. Evidence suggests that monitoring methods that concentrate on what is critical for a study and a site may produce better outcomes than do conventional SDV-driven models. This article assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits. The results support the hypothesis that generalized SDV has limited value as a quality control measure and reinforce the value of other risk-based monitoring activities.

THE FATE of nuclear power plants is one of the more nettlesome issues facing electric utility industry restructuring in New York State. It is an issue that demands that the state government proceed with much caution and scrutiny to understand what role, if any, nuclear power should have in the new energy marketplace. Exposing nuclear power to the rigors of marketplace competition raises a number of health, safety and economic concerns for all New Yorkers. These concerns are especially significant for Long Islanders, who live just downwind of several reactors and whose primary utility owns a share of an upstate nuclear power plant that cost more than the Shoreham reactor to construct. Although New York has six commercial nuclear reactors, the PSC proceeding addressed only the four that it has authority to regulate: Nine Mile Point 1, owned by Niagara Mohawk Power; Nine Mile Point 2, owned by Niagara Mohawk, New York State Electric & Gas and three other co-owners including the Long Island Power Authority; R.E. Ginna, owned by Rochester Gas & Electric, and Indian Point 2, owned by Consolidated Edison.