Overview: The focus of scientific monitoring Is the application of quality assurance procedures and standards to monitor the overall scientific progress of institutional clinical trials and to ensure adherence to clinical trial and GCP requirements. This Includes review of the overall progress of each study-to ensure the safety of participants;validity of data, that the projected accrual goals are met on a timely basis, that excess accrual is avoided, that eligibility and evaluabillty rates do not fall below minimum acceptable standards, that stopping rules are appropriately adhered to, that risks are not excessive, and that adverse events are appropriately monitored and reported to the appropriate agencies. Inherent in this process is the goal of enhandng the quality of the research by providing the investigator with constructive criticism. The level of monitoring for each clinical trial is based on the degree of risk imposed by the research, judged Initially by the Cancer Protocol Committee, which classifies each study and assigns a monitoring level. Audits are then triggered by accrual milestones based on this Initial assessment. Scientific progress reviews occur, minimally, annually, and more frequently as determined by audit findings.
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