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.

TransCelerate recommends the creation of an integrated, multifaceted approach to proactively detect data quality issues. Detection methods should include a strategy tailored to the characteristics of the study. Some sponsors are taking advantage of more advanced methods and integrated processes and systems to proactively detect and address issues, relying on advances in technology to more efficiently review data in real time. Further research is underway to assess statistical data quality detection methodology in clinical trials.

Previous studies in other laboratories had indicated that some of the effects of parathyroid hormone on skeletal tissue and the renal tubule to influence ion metabolism can be produced by beta-adrenergic stimulation. Studies were carried out to determine whether the same adenylate cyclase system in rat renal cortex is activated by parathyroid hormone and isoproterenol. At maximal effective concentration of dose response, parathyroid hormone (2 \ m=x\\m=-\5 m) increased adenylate cyclase activity by some 415 per cent, isoproterenol (10\m=-\6m) increased activity by some 40 to 50 per cent, vasopressin (10\ m=-\ 5 m) increased activity by some 96 per cent and porcine calcitonin (10\m=-\5m) increased activity by some 92 per cent. Dl-propranolol (10\m=-\5m), a beta-adrenergic receptor blocking agent, prevented the increase in enzyme activity produced by isoproterenol (10\ m=-\ 6 m), did not diminish the increase in activity produced by parathyroid hormone (10\m=-\6m) and did not influence basal adenylate cyclase activity by itself.

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